Albendazole Dose Finding and Pharmacokinetics in Children and Adults
Study Details
Study Description
Brief Summary
This study is a single-blind randomized clinical trial conducted in rural Côte d'Ivoire. This study aims at providing evidence on the dose-response of increasing oral albendazole dosages against whipworm (T. trichiura) and hookworm infections in preschoolers (2-5 years), school-aged children (6-12 years) and adults (≥ 21 years).
The primary objective is to determine cure rates (primary end point, i.e. conversion from being egg positive pre-treatment to egg negative post-treatment). Secondary objectives involve the determination of egg reduction rates (the reduction in the number of excreted eggs from baseline (prior to treatment) to follow-up) and the assessment of safety of ascending dosages of albendazole (secondary end points). In addition, key pharmacokinetic parameters will be determined from blood samples collected with a micro-sampling device (secondary end point).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This study is a single-blind randomized clinical trial conducted in Côte d'Ivoire. This study aims at providing evidence on the efficacy and safety of ascending oral albendazole dosages in children and adults infected with T. trichiura and hookworm. In preschool-aged children (2-5 years) (i) 200 mg, (ii) 400 mg and (iii) 600 mg; in schoolchildren (6-12 years) and adults (≥ 21 years) (i) 200 mg (only for hookworm infections), (ii) 400 mg, (iii) 600 mg and (iv) 800 mg will be administered and efficacy, safety and pharmacokinetic parameters will be assessed.
The primary objective is to determine the dose-response based on cure rates of albendazole in preschool-aged children (2-5 years), school-aged children (6-12 years) and adults (≥ 21 years) infected with T. trichiura and hookworm.
The secondary objectives of the trial are to determine the efficacy based on egg reduction rates of albendazole in preschool-aged children, school-aged children and adults, to determine an exposure (including length of time that the drug concentration is above the MIC, Cmax, AUC)-response correlation of albendazole in preschool-aged children, school-aged children and adults, to evaluate the safety and tolerability of albendazole in preschool-aged children, school-aged children and adults, and to determine the efficacy against concomitant soil-transmitted helminthiasis (Ascaris lumbricoides).
After obtaining informed consent from individual/parents and/or caregiver, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination and venipuncture to examine biochemical parameters in the blood carried out by the study physician before treatment. Enrollment will be based on two stool samples that will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days.
All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians. Randomization of participants into the treatment arms will be stratified according to intensity of infection. All participants will be interviewed before treatment, 3 and 24 hours and 3 weeks after treatment about the occurrence of adverse events. Children and adults will be sampled using finger pricking for micro-blood sampling at 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing.
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis and an intention-to-treat analysis will be conducted. CRs will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment. Differences among CRs will be analysed by using crude logistic regressions and adjusted logistic regressions (adjustment for age, sex, and height).
Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 2,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs. Noncompartmental and nonlinear mixed-effects (NLME) modeling will be used to determine PK parameters.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 200 mg albendazole against T. trichiura in preschool-aged children or against hookworm infections in preschool-aged children, school-aged children and adults |
Drug: Albendazole
Single dose of albendazole (200mg, dependent on treatment cohort)
Other Names:
|
Experimental: 400 mg albendazole against T. trichiura in preschool-aged children, school-aged children and adults or against hookworm infections in preschool-aged children, school-aged children and adults |
Drug: Albendazole
Single dose of albendazole (400mg, dependent on treatment cohort)
Other Names:
|
Experimental: 600 mg albendazole against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults |
Drug: Albendazole
Single dose of albendazole (600mg, dependent on treatment cohort)
Other Names:
|
Experimental: 800 mg albendazole against T. trichiura in school-aged children and adults or against hookworm infections in school-aged children and adults |
Drug: Albendazole
Single dose of albendazole (800mg, dependent on treatment cohort)
Other Names:
|
Placebo Comparator: Placebo against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults |
Drug: Placebo
Matching placebo tablets will be obtained from Fagron, Germany.
|
Outcome Measures
Primary Outcome Measures
- Cure Rate Against T. Trichiura and Hookworm Infections [14-21 days after treatment]
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Secondary Outcome Measures
- Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively [14-21 days after treatment]
Percent change in geometric mean eggs per gram of stool from before to after treatment
- Maximum Concentration (Cmax) of Albendazole and Its Metabolites [0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing]
To determine maximum drug concentration (Cmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
- Time to Reach Cmax (Tmax) of Albendazole and Its Metabolites [0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing]
To determine time to reach Cmax (tmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
- Area Under the Curve (AUC) of Albendazole and Its Metabolites [0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing]
To determine the area under the curve (AUC) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female adults (≥21 years), preschool-aged children (2-5 years) and school-aged children (6-12 years) infected with T. trichiura/hookworm
-
Written informed consent/assent signed from parent/guardian
-
Positive for T. trichiura/hookworm by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
-
Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
Exclusion Criteria:
-
Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment and liver function tests.
-
Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
-
Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned test article administration.
-
Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
-
Known or suspected allergy to benzimidazoles.
-
Pregnant (urine testing) or breastfeeding women
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS) | Abidjan | Côte D'Ivoire |
Sponsors and Collaborators
- Jennifer Keiser
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 2
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Placebo against T. trichiura in preschool-aged children | 200 mg of albendazole against T. trichiura in preschool-aged children | 400 mg of albendazole against T. trichiura in preschool-aged children | 600 mg of albendazole against T. trichiura in preschool-aged children | Placebo against T. trichiura in school-aged children | 400 mg of albendazole against T. trichiura in school-aged children | 600 mg of albendazole against T. trichiura in school-aged children | 800 mg of albendazole against T. trichiura in school-aged children | Placebo against T. trichiura in adults | 400 mg of albendazole against T. trichiura in adults | 600 mg of albendazole against T. trichiura in adults | 800 mg of albendazole against T. trichiura in adults | Placebo against hookworm in preschool-aged children | 200 mg of albendazole against hookworm in preschool-aged children | 400 mg of albendazole against hookworm in preschool-aged children | 600 mg of albendazole against hookworm in preschool-aged children | Placebo against hookworm in school-aged children | 200 mg of albendazole against hookworm in school-aged children | 400 mg of albendazole against hookworm in school-aged children | 600 mg of albendazole against hookworm in school-aged children | 800 mg of albendazole against hookworm in school-aged children | Placebo against hookworm in adults | 200 mg of albendazole against hookworm in adults | 400 mg of albendazole against hookworm in adults | 600 mg of albendazole against hookworm in adults | 800 mg of albendazole against hookworm in adults |
Period Title: Overall Study | ||||||||||||||||||||||||||
STARTED | 27 | 27 | 30 | 27 | 46 | 45 | 46 | 43 | 10 | 11 | 9 | 12 | 0 | 13 | 13 | 12 | 24 | 27 | 27 | 29 | 26 | 40 | 41 | 38 | 40 | 37 |
COMPLETED | 24 | 21 | 23 | 18 | 46 | 43 | 43 | 41 | 7 | 9 | 8 | 11 | 0 | 13 | 13 | 12 | 23 | 27 | 27 | 28 | 25 | 35 | 35 | 30 | 39 | 34 |
NOT COMPLETED | 3 | 6 | 7 | 9 | 0 | 2 | 3 | 2 | 3 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 5 | 6 | 8 | 1 | 3 |
Baseline Characteristics
Arm/Group Title | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Placebo against T. trichiura in preschool-aged children | 200 mg of albendazole against T. trichiura in preschool-aged children | 400 mg of albendazole against T. trichiura in preschool-aged children | 600 mg of albendazole against T. trichiura in preschool-aged children | Placebo against T. trichiura in school-aged children | 400 mg of albendazole against T. trichiura in school-aged children | 600 mg of albendazole against T. trichiura in school-aged children | 800 mg of albendazole against T. trichiura in school-aged children | Placebo against T. trichiura in adults (>21 years) | 400 mg of albendazole against T. trichiura in adults | 600 mg of albendazole against T. trichiura in adults | 800 mg of albendazole against T. trichiura in adults | Placebo against hookworm in preschool-aged children | 200 mg of albendazole against hookworm in preschool-aged children | 400 mg of albendazole against hookworm in preschool-aged children | 600 mg of albendazole against hookworm in preschool-aged children | Placebo against hookworm in school-aged children | 200 mg of albendazole against hookworm in school-aged children | 400 mg of albendazole against hookworm in school-aged children | 600 mg of albendazole against hookworm in school-aged children | 800 mg of albendazole against hookworm in school-aged children | Placebo against hookworm in adults (>21 years) | 200 mg of albendazole against hookworm in adults | 400 mg of albendazole against hookworm in adults | 600 mg of albendazole against hookworm in adults | 800 mg of albendazole against hookworm in adults | Total of all reporting groups |
Overall Participants | 27 | 27 | 30 | 27 | 46 | 45 | 46 | 43 | 10 | 11 | 9 | 12 | 0 | 13 | 13 | 12 | 24 | 27 | 27 | 29 | 26 | 40 | 41 | 38 | 40 | 37 | 700 |
Age (years) [Mean (Standard Deviation) ] | |||||||||||||||||||||||||||
Age |
4.1
(0.9)
|
4.0
(0.9)
|
3.8
(1.1)
|
4.0
(0.9)
|
8.9
(1.9)
|
8.9
(1.9)
|
8.7
(2.0)
|
8.8
(1.8)
|
44.3
(12.3)
|
40.5
(11.9)
|
36.6
(12.2)
|
44.8
(15.9)
|
3.8
(1.2)
|
3.8
(1.3)
|
3.8
(1.1)
|
9.1
(2.2)
|
9.1
(1.9)
|
9.8
(1.9)
|
9.2
(2.2)
|
9.4
(2.3)
|
35.4
(10.3)
|
39.8
(12.2)
|
36.3
(12.2)
|
39.2
(11.5)
|
35.7
(12.0)
|
17.7
(16.3)
|
|
Sex: Female, Male (Count of Participants) | |||||||||||||||||||||||||||
Female |
16
59.3%
|
18
66.7%
|
16
53.3%
|
18
66.7%
|
25
54.3%
|
15
33.3%
|
19
41.3%
|
17
39.5%
|
6
60%
|
9
81.8%
|
7
77.8%
|
8
66.7%
|
5
Infinity
|
9
69.2%
|
8
61.5%
|
8
66.7%
|
12
50%
|
8
29.6%
|
5
18.5%
|
7
24.1%
|
7
26.9%
|
16
40%
|
7
17.1%
|
7
18.4%
|
9
22.5%
|
282
762.2%
|
|
Male |
11
40.7%
|
9
33.3%
|
14
46.7%
|
9
33.3%
|
21
45.7%
|
30
66.7%
|
27
58.7%
|
26
60.5%
|
4
40%
|
2
18.2%
|
2
22.2%
|
4
33.3%
|
8
Infinity
|
4
30.8%
|
4
30.8%
|
16
133.3%
|
15
62.5%
|
19
70.4%
|
24
88.9%
|
19
65.5%
|
33
126.9%
|
25
62.5%
|
31
75.6%
|
33
86.8%
|
28
70%
|
418
1129.7%
|
|
Race and Ethnicity Not Collected (Count of Participants) | |||||||||||||||||||||||||||
Count of Participants [Participants] |
0
0%
|
||||||||||||||||||||||||||
T. trichuris median eggs per gram (eggs per gram of stool) [Median (Inter-Quartile Range) ] | |||||||||||||||||||||||||||
Median (Inter-Quartile Range) [eggs per gram of stool] |
216
|
264
|
210
|
228
|
387
|
426
|
507
|
414
|
138
|
168
|
156
|
195
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
294
|
|
T. trichuris infection intensity (Count of Participants) | |||||||||||||||||||||||||||
Light (1-999 epg) |
22
81.5%
|
22
81.5%
|
24
80%
|
21
77.8%
|
32
69.6%
|
30
66.7%
|
31
67.4%
|
30
69.8%
|
10
100%
|
10
90.9%
|
9
100%
|
10
83.3%
|
0
NaN
|
0
0%
|
1
7.7%
|
2
16.7%
|
2
8.3%
|
0
0%
|
0
0%
|
2
6.9%
|
1
3.8%
|
0
0%
|
0
0%
|
0
0%
|
1
2.5%
|
260
702.7%
|
|
Moderate (1000-9999 epg) |
4
14.8%
|
5
18.5%
|
5
16.7%
|
6
22.2%
|
14
30.4%
|
15
33.3%
|
15
32.6%
|
12
27.9%
|
0
0%
|
1
9.1%
|
0
0%
|
2
16.7%
|
0
NaN
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
79
213.5%
|
|
Heavy (>= 10000 epg) |
1
3.7%
|
0
0%
|
1
3.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
8.1%
|
|
Not infected |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
13
Infinity
|
13
100%
|
11
84.6%
|
22
183.3%
|
25
104.2%
|
27
100%
|
29
107.4%
|
24
82.8%
|
39
150%
|
41
102.5%
|
38
92.7%
|
40
105.3%
|
36
90%
|
358
967.6%
|
|
hookworm median eggs per gram (eggs per gram of stool) [Median (Inter-Quartile Range) ] | |||||||||||||||||||||||||||
Median (Inter-Quartile Range) [eggs per gram of stool] |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
216
|
126
|
252
|
183
|
126
|
138
|
156
|
153
|
157
|
126
|
96
|
189
|
114
|
132
|
|
hookworm infection intensity (Count of Participants) | |||||||||||||||||||||||||||
Light (1-1999 epg) |
0
0%
|
0
0%
|
1
3.3%
|
0
0%
|
1
2.2%
|
1
2.2%
|
2
4.3%
|
3
7%
|
1
10%
|
1
9.1%
|
0
0%
|
0
0%
|
12
Infinity
|
12
92.3%
|
11
84.6%
|
22
183.3%
|
26
108.3%
|
27
100%
|
27
100%
|
24
82.8%
|
38
146.2%
|
40
100%
|
38
92.7%
|
40
105.3%
|
36
90%
|
363
981.1%
|
|
Moderate (2000-3999 epg) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
Infinity
|
1
7.7%
|
1
7.7%
|
2
16.7%
|
1
4.2%
|
0
0%
|
2
7.4%
|
0
0%
|
2
7.7%
|
1
2.5%
|
0
0%
|
0
0%
|
1
2.5%
|
12
32.4%
|
|
Heavy (>= 4000 epg) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
6.9%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
5.4%
|
|
Not infected |
27
100%
|
27
100%
|
29
96.7%
|
27
100%
|
45
97.8%
|
44
97.8%
|
44
95.7%
|
40
93%
|
9
90%
|
10
90.9%
|
9
100%
|
12
100%
|
0
NaN
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
323
873%
|
|
A. lumbricoides infection intensity (Count of Participants) | |||||||||||||||||||||||||||
Light (1-4999 epg) |
2
7.4%
|
2
7.4%
|
3
10%
|
2
7.4%
|
8
17.4%
|
8
17.8%
|
4
8.7%
|
6
14%
|
0
0%
|
1
9.1%
|
0
0%
|
2
16.7%
|
1
Infinity
|
0
0%
|
1
7.7%
|
1
8.3%
|
1
4.2%
|
0
0%
|
1
3.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.6%
|
0
0%
|
44
118.9%
|
|
Moderate (5000-49999 epg) |
2
7.4%
|
6
22.2%
|
2
6.7%
|
1
3.7%
|
5
10.9%
|
9
20%
|
6
13%
|
7
16.3%
|
0
0%
|
2
18.2%
|
0
0%
|
1
8.3%
|
0
NaN
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
41
110.8%
|
|
Heavy (>= 50000 epg) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.7%
|
|
Not infected |
23
85.2%
|
19
70.4%
|
25
83.3%
|
24
88.9%
|
33
71.7%
|
27
60%
|
36
78.3%
|
30
69.8%
|
10
100%
|
8
72.7%
|
9
100%
|
9
75%
|
12
Infinity
|
13
100%
|
11
84.6%
|
23
191.7%
|
26
108.3%
|
27
100%
|
28
103.7%
|
26
89.7%
|
40
153.8%
|
41
102.5%
|
38
92.7%
|
39
102.6%
|
37
92.5%
|
614
1659.5%
|
Outcome Measures
Title | Cure Rate Against T. Trichiura and Hookworm Infections |
---|---|
Description | The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR). |
Time Frame | 14-21 days after treatment |
Outcome Measure Data
Analysis Population Description |
---|
An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis. |
Arm/Group Title | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Placebo against T. trichiura in preschool-aged children | 200 mg of albendazole against T. trichiura in preschool-aged children | 400 mg of albendazole against T. trichiura in preschool-aged children | 600 mg of albendazole against T. trichiura in preschool-aged children | Placebo against T. trichiura in school-aged children | 400 mg of albendazole against T. trichiura in school-aged children | 600 mg of albendazole against T. trichiura in school-aged children | 800 mg of albendazole against T. trichiura in school-aged children | Placebo against T. trichiura in adults | 400 mg of albendazole against T. trichiura in adults | 600 mg of albendazole against T. trichiura in adults | 800 mg of albendazole against T. trichiura in adults | Placebo against hookworm in preschool-aged children | 200 mg of albendazole against hookworm in preschool-aged children | 400 mg of albendazole against hookworm in preschool-aged children | 600 mg of albendazole against hookworm in preschool-aged children | Placebo against hookworm in school-aged children | 200 mg of albendazole against hookworm in school-aged children | 400 mg of albendazole against hookworm in school-aged children | 600 mg of albendazole against hookworm in school-aged children | 800 mg of albendazole against hookworm in school-aged children | Placebo against hookworm in adults | 200 mg of albendazole against hookworm in adults | 400 mg of albendazole against hookworm in adults | 600 mg of albendazole against hookworm in adults | 800 mg of albendazole against hookworm in adults |
Measure Participants | 24 | 21 | 23 | 18 | 46 | 43 | 43 | 41 | 7 | 9 | 8 | 11 | 0 | 13 | 13 | 12 | 23 | 27 | 27 | 28 | 25 | 35 | 35 | 30 | 39 | 34 |
Cured |
4
14.8%
|
2
7.4%
|
4
13.3%
|
5
18.5%
|
3
6.5%
|
7
15.6%
|
11
23.9%
|
7
16.3%
|
1
10%
|
5
45.5%
|
4
44.4%
|
3
25%
|
9
Infinity
|
8
61.5%
|
10
76.9%
|
10
83.3%
|
17
70.8%
|
20
74.1%
|
18
66.7%
|
19
65.5%
|
5
19.2%
|
16
40%
|
16
39%
|
22
57.9%
|
32
80%
|
|
Not cured |
20
74.1%
|
19
70.4%
|
19
63.3%
|
13
48.1%
|
43
93.5%
|
36
80%
|
32
69.6%
|
34
79.1%
|
6
60%
|
4
36.4%
|
4
44.4%
|
8
66.7%
|
4
Infinity
|
5
38.5%
|
2
15.4%
|
13
108.3%
|
10
41.7%
|
7
25.9%
|
10
37%
|
6
20.7%
|
30
115.4%
|
19
47.5%
|
14
34.1%
|
17
44.7%
|
2
5%
|
Title | Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively |
---|---|
Description | Percent change in geometric mean eggs per gram of stool from before to after treatment |
Time Frame | 14-21 days after treatment |
Outcome Measure Data
Analysis Population Description |
---|
An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis. |
Arm/Group Title | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Placebo against T. trichiura in preschool-aged children | 200 mg of albendazole against T. trichiura in preschool-aged children | 400 mg of albendazole against T. trichiura in preschool-aged children | 600 mg of albendazole against T. trichiura in preschool-aged children | Placebo against T. trichiura in school-aged children | 400 mg of albendazole against T. trichiura in school-aged children | 600 mg of albendazole against T. trichiura in school-aged children | 800 mg of albendazole against T. trichiura in school-aged children | Placebo against T. trichiura in adults (>21 years) | 400 mg of albendazole against T. trichiura in adults | 600 mg of albendazole against T. trichiura in adults | 800 mg of albendazole against T. trichiura in adults | Placebo against hookworm in preschool-aged children | 200 mg of albendazole against hookworm in preschool-aged children | 400 mg of albendazole against hookworm in preschool-aged children | 600 mg of albendazole against hookworm in preschool-aged children | Placebo against hookworm in school-aged children | 200 mg of albendazole against hookworm in school-aged children | 400 mg of albendazole against hookworm in school-aged children | 600 mg of albendazole against hookworm in school-aged children | 800 mg of albendazole against hookworm in school-aged children | Placebo against hookworm in adults (>21 years) | 200 mg of albendazole against hookworm in adults | 400 mg of albendazole against hookworm in adults | 600 mg of albendazole against hookworm in adults | 800 mg of albendazole against hookworm in adults |
Measure Participants | 24 | 21 | 23 | 18 | 46 | 43 | 43 | 41 | 7 | 9 | 8 | 11 | 0 | 13 | 13 | 12 | 23 | 27 | 27 | 28 | 25 | 35 | 35 | 30 | 39 | 34 |
Geometric Mean (95% Confidence Interval) [percent change] |
79.1
|
63.8
|
87.1
|
88.5
|
55.9
|
82.0
|
88.4
|
78.7
|
85.2
|
97.7
|
94.7
|
92.6
|
99.0
|
96.2
|
99.6
|
90.6
|
97.7
|
99.0
|
98.3
|
98.4
|
33.0
|
93.8
|
95.8
|
97.0
|
99.8
|
Title | Maximum Concentration (Cmax) of Albendazole and Its Metabolites |
---|---|
Description | To determine maximum drug concentration (Cmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml. |
Time Frame | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Time to Reach Cmax (Tmax) of Albendazole and Its Metabolites |
---|---|
Description | To determine time to reach Cmax (tmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml. |
Time Frame | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Area Under the Curve (AUC) of Albendazole and Its Metabolites |
---|---|
Description | To determine the area under the curve (AUC) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml. |
Time Frame | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | Adverse events were collected at 3 hours and 24 hours after treatment. | |||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm. | |||||||||||||||||||||||||||||||||||||||||||||||||||
Arm/Group Title | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | ||||||||||||||||||||||||||
Arm/Group Description | Placebo against T. trichiura in preschool-aged children | 200 mg of albendazole against T. trichiura in preschool-aged children | 400 mg of albendazole against T. trichiura in preschool-aged children | 600 mg of albendazole against T. trichiura in preschool-aged children | Placebo against T. trichiura in school-aged children | 400 mg of albendazole against T. trichiura in school-aged children | 600 mg of albendazole against T. trichiura in school-aged children | 800 mg of albendazole against T. trichiura in school-aged children | Placebo against T. trichiura in adults | 400 mg of albendazole against T. trichiura in adults | 600 mg of albendazole against T. trichiura in adults | 800 mg of albendazole against T. trichiura in adults | Placebo against hookworm in preschool-aged children | 200 mg of albendazole against hookworm in preschool-aged children | 400 mg of albendazole against hookworm in preschool-aged children | 600 mg of albendazole against hookworm in preschool-aged children | Placebo against hookworm in school-aged children | 200 mg of albendazole against hookworm in school-aged children | 400 mg of albendazole against hookworm in school-aged children | 600 mg of albendazole against hookworm in school-aged children | 800 mg of albendazole against hookworm in school-aged children | Placebo against hookworm in adults | 200 mg of albendazole against hookworm in adults | 400 mg of albendazole against hookworm in adults | 600 mg of albendazole against hookworm in adults | 800 mg of albendazole against hookworm in adults | ||||||||||||||||||||||||||
All Cause Mortality |
||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | |||||||||||||||||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/27 (0%) | 0/27 (0%) | 0/30 (0%) | 0/27 (0%) | 0/46 (0%) | 0/45 (0%) | 0/46 (0%) | 0/43 (0%) | 0/10 (0%) | 0/11 (0%) | 0/9 (0%) | 0/12 (0%) | 0/0 (NaN) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 0/24 (0%) | 0/27 (0%) | 0/27 (0%) | 0/29 (0%) | 0/26 (0%) | 0/40 (0%) | 0/41 (0%) | 0/38 (0%) | 0/40 (0%) | 0/37 (0%) | ||||||||||||||||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | |||||||||||||||||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/27 (0%) | 1/27 (3.7%) | 0/30 (0%) | 0/27 (0%) | 0/46 (0%) | 0/45 (0%) | 0/46 (0%) | 0/43 (0%) | 0/10 (0%) | 0/11 (0%) | 0/9 (0%) | 0/12 (0%) | 0/0 (NaN) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 0/24 (0%) | 0/27 (0%) | 0/27 (0%) | 0/29 (0%) | 0/26 (0%) | 0/40 (0%) | 0/41 (0%) | 0/38 (0%) | 0/40 (0%) | 0/37 (0%) | ||||||||||||||||||||||||||
Infections and infestations | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Inpatient hospitalization due to clinical malaria | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 | 0/30 (0%) | 0 | 0/27 (0%) | 0 | 0/46 (0%) | 0 | 0/45 (0%) | 0 | 0/46 (0%) | 0 | 0/43 (0%) | 0 | 0/10 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/12 (0%) | 0 | 0/0 (NaN) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/12 (0%) | 0 | 0/24 (0%) | 0 | 0/27 (0%) | 0 | 0/27 (0%) | 0 | 0/29 (0%) | 0 | 0/26 (0%) | 0 | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 0/38 (0%) | 0 | 0/40 (0%) | 0 | 0/37 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||||||||||||||||||||||||||
Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | |||||||||||||||||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/27 (11.1%) | 2/27 (7.4%) | 3/30 (10%) | 2/27 (7.4%) | 4/46 (8.7%) | 9/45 (20%) | 8/46 (17.4%) | 8/43 (18.6%) | 3/10 (30%) | 3/11 (27.3%) | 2/9 (22.2%) | 2/12 (16.7%) | 0/0 (NaN) | 1/13 (7.7%) | 0/13 (0%) | 1/12 (8.3%) | 2/24 (8.3%) | 3/27 (11.1%) | 2/27 (7.4%) | 1/29 (3.4%) | 3/26 (11.5%) | 2/40 (5%) | 4/41 (9.8%) | 5/38 (13.2%) | 3/40 (7.5%) | 4/37 (10.8%) | ||||||||||||||||||||||||||
Gastrointestinal disorders | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Abdominal pain | 1/27 (3.7%) | 0/27 (0%) | 1/30 (3.3%) | 2/27 (7.4%) | 4/46 (8.7%) | 4/45 (8.9%) | 3/46 (6.5%) | 7/43 (16.3%) | 2/10 (20%) | 3/11 (27.3%) | 1/9 (11.1%) | 0/12 (0%) | 0/0 (NaN) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 1/24 (4.2%) | 2/27 (7.4%) | 2/27 (7.4%) | 1/29 (3.4%) | 3/26 (11.5%) | 0/40 (0%) | 1/41 (2.4%) | 1/38 (2.6%) | 2/40 (5%) | 3/37 (8.1%) | ||||||||||||||||||||||||||
Nausea | 0/27 (0%) | 0/27 (0%) | 0/30 (0%) | 0/27 (0%) | 0/46 (0%) | 0/45 (0%) | 0/46 (0%) | 0/43 (0%) | 0/10 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/12 (0%) | 0/0 (NaN) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 0/24 (0%) | 0/27 (0%) | 0/27 (0%) | 0/29 (0%) | 0/26 (0%) | 0/40 (0%) | 0/41 (0%) | 0/38 (0%) | 0/40 (0%) | 1/37 (2.7%) | ||||||||||||||||||||||||||
Vomiting | 0/27 (0%) | 0/27 (0%) | 0/30 (0%) | 0/27 (0%) | 1/46 (2.2%) | 0/45 (0%) | 0/46 (0%) | 0/43 (0%) | 0/10 (0%) | 0/11 (0%) | 0/9 (0%) | 0/12 (0%) | 0/0 (NaN) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 0/24 (0%) | 0/27 (0%) | 0/27 (0%) | 0/29 (0%) | 0/26 (0%) | 0/40 (0%) | 0/41 (0%) | 0/38 (0%) | 0/40 (0%) | 0/37 (0%) | ||||||||||||||||||||||||||
Infections and infestations | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Diarrhea | 1/27 (3.7%) | 0/27 (0%) | 2/30 (6.7%) | 1/27 (3.7%) | 2/46 (4.3%) | 3/45 (6.7%) | 1/46 (2.2%) | 0/43 (0%) | 0/10 (0%) | 0/11 (0%) | 0/9 (0%) | 0/12 (0%) | 0/0 (NaN) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 0/24 (0%) | 0/27 (0%) | 0/27 (0%) | 0/29 (0%) | 0/26 (0%) | 0/40 (0%) | 0/41 (0%) | 0/38 (0%) | 0/40 (0%) | 0/37 (0%) | ||||||||||||||||||||||||||
Nervous system disorders | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Headache | 1/27 (3.7%) | 2/27 (7.4%) | 3/30 (10%) | 0/27 (0%) | 3/46 (6.5%) | 1/45 (2.2%) | 3/46 (6.5%) | 5/43 (11.6%) | 1/10 (10%) | 3/11 (27.3%) | 2/9 (22.2%) | 2/12 (16.7%) | 2/0 (Infinity) | 1/13 (7.7%) | 0/13 (0%) | 1/12 (8.3%) | 1/24 (4.2%) | 1/27 (3.7%) | 0/27 (0%) | 0/29 (0%) | 0/26 (0%) | 2/40 (5%) | 3/41 (7.3%) | 4/38 (10.5%) | 2/40 (5%) | 1/37 (2.7%) | ||||||||||||||||||||||||||
Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Itching | 0/27 (0%) | 0/27 (0%) | 0/30 (0%) | 0/27 (0%) | 0/46 (0%) | 1/45 (2.2%) | 1/46 (2.2%) | 0/43 (0%) | 0/10 (0%) | 0/11 (0%) | 0/9 (0%) | 1/12 (8.3%) | 1/0 (Infinity) | 0/13 (0%) | 0/13 (0%) | 0/12 (0%) | 0/24 (0%) | 0/27 (0%) | 0/27 (0%) | 0/29 (0%) | 0/26 (0%) | 0/40 (0%) | 0/41 (0%) | 0/38 (0%) | 0/40 (0%) | 0/37 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Jennifer Keiser, PhD |
---|---|
Organization | Swiss Tropical and Public Health Institute |
Phone | +41 (61) 284 8218 |
jennifer.keiser@swisstph.ch |
- 2