DOLF-Indo: Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis
Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01905423
Collaborator
(none)
17,108
1
55
310.9
Study Details
Study Description
Brief Summary
Approximately 3,500 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis endemic areas. The study will be performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Purpose of the study is to evaluate different mass drug administration (MDA) regimens for lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this study may enhance efforts to control and eliminate these important neglected tropical diseases.
The investigators will test the hypothesis that accelerated mass drug administration will be superior to annual MDA for elimination of lymphatic filariasis and for control of soil transmitted helminth infections (STH):
-
Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF).
-
Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes elephantiasis and genital deformity (especially hydroceles). The infection affects some 120 million people in 81 countries in tropical and subtropical regions with well over 1 billion people at risk of acquiring the disease. LF is caused by Wuchereria bancrofti and Brugia spp. (B. malayi and B.timori), nematode parasites that are transmitted by mosquitoes. This study is based on the assumption that currently used mass drug administration (MDA) regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine (DEC) 6 mg/kg or Alb 400 mg plus ivermectin (Iver) 200 µg/kg for LF) were developed more than 10 years ago.
Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelminthics usually target special groups of the population, such as schoolchildren, and have limited impact on the transmission. Treatment of the total population and semiannual treatments may reduce re-infection considerably and will most likely lead to reduced infection densities and infection prevalences. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections.
Purpose: The study aims to compare the effectiveness once yearly (1X) versus twice yearly (2X) mass drug administration (MDA) for the elimination of lymphatic filariasis and for control of soil-transmitted helminths (intestinal parasites) in large populations. Mass drug administration will be provided by the Indonesia Ministry of Health. This project will assess the impact of the public health program.
Procedures: Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). Stool samples will be collected to detect STH infections. All assays will be performed in Indonesia (filarial serology tests, blood smears for detection of microfilariae (MF), and stool examinations for detection of worm eggs).
Washington University researchers developed the protocol, will provide training and guidance to Indonesian researchers, and work with them to analyze the data. Indonesian researchers will consent the participants, obtain stool and blood specimens, perform laboratory tests on the specimens, and enter data on participants and lab results.
Study Design
Study Type:
Observational
Actual Enrollment
:
17108 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis
Actual Study Start Date
:
May 1, 2011
Actual Primary Completion Date
:
Mar 1, 2015
Actual Study Completion Date
:
Dec 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Paga (annual MDA) This group includes eligible residents of the village of Paga. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Paga received a total of three rounds of MDA over a period of 24 months (once every 12 months). |
Drug: Albendazole (annual)
Albendazole 400 mg pnce annually
Other Names:
Drug: Diethylcarbamazine (annual)
Diethylcarbamazine 6 mg/kg once annually
Other Names:
|
| Lewomada (annual MDA) This group includes eligible residents of the village of Lewomada. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Lewomada received a total of three rounds of MDA over a period of 24 months (once every 12 months). |
Drug: Albendazole (annual)
Albendazole 400 mg pnce annually
Other Names:
Drug: Diethylcarbamazine (annual)
Diethylcarbamazine 6 mg/kg once annually
Other Names:
|
| Pruda (semiannual MDA) This group includes eligible residents of the village of Pruda. This cohort will receive twice yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Pruda received a total of five rounds of MDA over a period of 24 months (once every 6 months). |
Drug: Albendazole (semiannual)
Albendazole 400 mg twice annually
Other Names:
Drug: Diethylcarbamazine (semiannual)
Diethylcarbamazine 6 mg/kg twice annually
Other Names:
|
| Pekalongan (annual MDA) This group includes the villages of Banyurip Ageng and Jenggot. This cohort will receive once yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis. |
Drug: Albendazole (annual)
Albendazole 400 mg pnce annually
Other Names:
Drug: Diethylcarbamazine (annual)
Diethylcarbamazine 6 mg/kg once annually
Other Names:
|
| Pekalongan (semiannual MDA) This group includes the villages of Kertoharjo and Pabean. This cohort will receive twice yearly MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis. |
Drug: Albendazole (semiannual)
Albendazole 400 mg twice annually
Other Names:
Drug: Diethylcarbamazine (semiannual)
Diethylcarbamazine 6 mg/kg twice annually
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood [3 years]
Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual and semiannual community surveys. Prevalence rates (a measure of the disease rates in the population sampled) are expressed as % positive for microfilaremia (having microfilaria in the blood).
Secondary Outcome Measures
- Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests [3 years]
This outcome is reported as the frequency of participants with positive Brugia Rapid antifilarial antibody tests. Data was only collected at baseline and at year 3 for this outcome measure and no antibody data was collected for the Pekalongan study sites.
- Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test [3 years]
Prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test "ICT" card test) among the population surveyed. Prevalence data are expressed as %.
- Prevalence of Ascaris Infection [2 Years]
Prevalence of Ascaris infection is defined by the number of participants with any Ascaris worm eggs present in their stool sample as analyzed with microscopy.
- Prevalence of Hookworm Infection [2 years]
Prevalence of hookworm infection is defined by the number of participants with any hookworm eggs present in their stool sample as analyzed with microscopy.
- Prevalence of Trichuris Infection [2 years]
Prevalence of trichuris infection is defined by the number of participants with any trichuris worm eggs present in their stool sample as analyzed with microscopy.
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Areas should be endemic for filariasis and have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age.
Exclusion Criteria:
- Children less than 5 years of age.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Indonesia, Department of Parasitology | Jakarta | Java | Indonesia | 10430 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Peter U Fischer, Ph.D., Washington University School of Medicine
- Principal Investigator: Gary J Weil, MD, Washington University School of Medicine
- Study Director: Taniawati Supali, Ph.D., Indonesia University
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Gary Weil, MD,
Professor of Medicine/ Microbiology,
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01905423
Other Study ID Numbers:
- 201103313
First Posted:
Jul 23, 2013
Last Update Posted:
Nov 17, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gary Weil, MD,
Professor of Medicine/ Microbiology,
Washington University School of Medicine
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This was a cross-sectional study. The final end points of the study are measures of community prevalence. Participant involvement in the study ended after each survey period. Participants were not followed across survey periods, but could be and were likely recruited into more than one survey period. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Arm/Group Description | The village of Paga received once annual MDA for a total of 3 rounds over 24 months. | Village of Lewomada received once annual MDA for a total of 3 rounds over 24 months. | The village of Pruda received twice annual MDA for a total of 5 rounds over 24 months. | The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group received one round of MDA and was surveyed one year later. | The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group received two rounds of MDA and was surveyed one year later. |
| Period Title: Overall Study | |||||
| STARTED | 4456 | 3297 | 4111 | 2757 | 2487 |
| Baseline | 1443 | 722 | 1033 | 1482 | 1326 |
| Year 1 Follow-up | 994 | 846 | 1007 | 1275 | 1161 |
| Year 2 Follow-up | 1114 | 858 | 1043 | 0 | 0 |
| Year 3 Follow-up | 905 | 871 | 1028 | 0 | 0 |
| COMPLETED | 4456 | 3297 | 4111 | 2757 | 2487 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Annual MDA Treated Group (Paga) | Annual MDA Treated Group (Lewomada) | Semiannual MDA Treated Group | Annual MDA Treated Group (Pekalongan) | Semiannual MDA Treated Group (Pekalongan) | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly | This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly | This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly | The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly | The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly | Total of all reporting groups |
| Overall Participants | 1443 | 722 | 1033 | 1482 | 1326 | 6006 |
| Age, Customized (Count of Participants) | ||||||
| 15 years and younger |
597
41.4%
|
285
39.5%
|
374
36.2%
|
353
23.8%
|
372
28.1%
|
1981
33%
|
| Older than 15 |
794
55%
|
437
60.5%
|
653
63.2%
|
1129
76.2%
|
954
71.9%
|
3967
66.1%
|
| Age unknown |
52
3.6%
|
0
0%
|
6
0.6%
|
0
0%
|
0
0%
|
58
1%
|
| Sex/Gender, Customized (Count of Participants) | ||||||
| Females |
897
62.2%
|
411
56.9%
|
545
52.8%
|
816
55.1%
|
721
54.4%
|
3390
56.4%
|
| Males |
546
37.8%
|
311
43.1%
|
488
47.2%
|
666
44.9%
|
605
45.6%
|
2616
43.6%
|
| Gender unknown |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood |
|---|---|
| Description | Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual and semiannual community surveys. Prevalence rates (a measure of the disease rates in the population sampled) are expressed as % positive for microfilaremia (having microfilaria in the blood). |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pekalongan study sites were dropped after the first year due to lower than expected prevalence of lymphatic filariasis infections. The overall number of participants analyzed for each group may be slightly less than the total sample size for that group due to the fact that not all data was collected for all participants. |
| Arm/Group Title | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly |
| Measure Participants | 4401 | 3297 | 4079 | 2730 | 2427 |
| Baseline (pre-MDA) |
54
3.7%
|
36
5%
|
146
14.1%
|
46
3.1%
|
45
3.4%
|
| Year 1 |
11
0.8%
|
9
1.2%
|
37
3.6%
|
28
1.9%
|
30
2.3%
|
| Year 2 |
6
0.4%
|
6
0.8%
|
15
1.5%
|
0
0%
|
0
0%
|
| Year 3 |
0
0%
|
3
0.4%
|
12
1.2%
|
0
0%
|
0
0%
|
| Title | Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests |
|---|---|
| Description | This outcome is reported as the frequency of participants with positive Brugia Rapid antifilarial antibody tests. Data was only collected at baseline and at year 3 for this outcome measure and no antibody data was collected for the Pekalongan study sites. |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome data was only collected at baseline and at year 3 for Paga & Pruda and no antibody data was collected at all for the Pekalongan study sites. The overall number of participants analyzed for each group may be less than the total sample size for that group due to the fact that not all data was collected for all participants. |
| Arm/Group Title | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly |
| Measure Participants | 2308 | 3297 | 2054 | 0 | 0 |
| Baseline |
175
12.1%
|
229
31.7%
|
297
28.8%
|
0
0%
|
0
0%
|
| Year 1 |
0
0%
|
168
23.3%
|
0
0%
|
0
0%
|
0
0%
|
| Year 2 |
0
0%
|
134
18.6%
|
0
0%
|
0
0%
|
0
0%
|
| Year 3 |
16
1.1%
|
36
5%
|
37
3.6%
|
0
0%
|
0
0%
|
| Title | Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test |
|---|---|
| Description | Prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test "ICT" card test) among the population surveyed. Prevalence data are expressed as %. |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome data was not collected for Paga at year 3 or for Pekalongan sites after year 1 (Pekalongan study site was dropped completely after year 1). The overall number of participants analyzed for each group may be less than the total sample size for that group due to the fact that not all data was collected for all participants. |
| Arm/Group Title | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly |
| Measure Participants | 3511 | 3297 | 4095 | 2696 | 2407 |
| Baseline |
14
1%
|
47
6.5%
|
235
22.7%
|
118
8%
|
102
7.7%
|
| Year 1 |
0
0%
|
12
1.7%
|
91
8.8%
|
51
3.4%
|
63
4.8%
|
| Year 2 |
2
0.1%
|
13
1.8%
|
106
10.3%
|
0
0%
|
0
0%
|
| Year 3 |
0
0%
|
36
5%
|
72
7%
|
0
0%
|
0
0%
|
| Title | Prevalence of Ascaris Infection |
|---|---|
| Description | Prevalence of Ascaris infection is defined by the number of participants with any Ascaris worm eggs present in their stool sample as analyzed with microscopy. |
| Time Frame | 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pekalongan study sites were dropped after the first year. No soil transmitted helminth infection data was collected after year 2. The overall number of participants analyzed for each group may be slightly less than the total sample size for that group due to the fact that not all data was collected for all participants. |
| Arm/Group Title | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly |
| Measure Participants | 708 | 1230 | 523 | 699 | 792 |
| Baseline |
88
6.1%
|
56
7.8%
|
34
3.3%
|
19
1.3%
|
58
4.4%
|
| Year 1 |
135
9.4%
|
17
2.4%
|
7
0.7%
|
11
0.7%
|
6
0.5%
|
| Year 2 |
107
7.4%
|
18
2.5%
|
3
0.3%
|
0
0%
|
0
0%
|
| Title | Prevalence of Hookworm Infection |
|---|---|
| Description | Prevalence of hookworm infection is defined by the number of participants with any hookworm eggs present in their stool sample as analyzed with microscopy. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Hookworm prevalence was not analyzed for Pekalongan sites. Hookworm data was not collected after year 2 for any sites. The overall number of participants analyzed for each group may be slightly less than the total sample size for that group due to the fact that not all data was collected for all participants. |
| Arm/Group Title | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly |
| Measure Participants | 708 | 1230 | 523 | 0 | 0 |
| Baseline |
25
1.7%
|
226
31.3%
|
35
3.4%
|
0
0%
|
0
0%
|
| Year 1 |
118
8.2%
|
118
16.3%
|
90
8.7%
|
0
0%
|
0
0%
|
| Year 2 |
65
4.5%
|
97
13.4%
|
87
8.4%
|
0
0%
|
0
0%
|
| Title | Prevalence of Trichuris Infection |
|---|---|
| Description | Prevalence of trichuris infection is defined by the number of participants with any trichuris worm eggs present in their stool sample as analyzed with microscopy. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pekalongan study sites were dropped after the first year. No soil transmitted helminth infection data was collected after year 2. The overall number of participants analyzed for each group may be slightly less than the total sample size for that group due to the fact that not all data was collected for all participants. |
| Arm/Group Title | Paga (1x Annual MDA) | Lewomada (1x Annual MDA) | Pruda (2x Annual MDA) | Pekalongan (1x Annual MDA) | Pekalongan (2x Annual MDA) |
|---|---|---|---|---|---|
| Arm/Group Description | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly | Participants from this village receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly |
| Measure Participants | 708 | 1230 | 523 | 699 | 792 |
| Baseline |
68
4.7%
|
45
6.2%
|
8
0.8%
|
120
8.1%
|
352
26.5%
|
| Year 1 |
93
6.4%
|
25
3.5%
|
8
0.8%
|
35
2.4%
|
65
4.9%
|
| Year 2 |
84
5.8%
|
23
3.2%
|
13
1.3%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Subjects will be monitored for adverse events related to blood collection at each year of observation. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | This is a minimal risk and nonintervention study. Adverse events are not expected to be an issue. However, subjects will be monitored for adverse events related to blood collection. | |||||||||
| Arm/Group Title | Paga (Annual MDA) | Lewomada (Annual MDA) | Pruda (Semiannual MDA) | Pekalongan (Annual MDA) | Pekalongan (Semiannual MDA) | |||||
| Arm/Group Description | This group includes eligible residents of the village of Paga. This cohort will receive once yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Paga received a total of three rounds of MDA over a period of 24 months (once every 12 months). | This group includes eligible residents of the village of Lewomada. This cohort will receive once yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Lewomada received a total of three rounds of MDA over a period of 24 months (once every 12 months). | This group includes eligible residents of the village of Pruda. This cohort will receive twice yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Pruda received a total of five rounds of MDA over a period of 24 months (once every 6 months). | This group includes villages of Banyurip Ageng and Jenggot. This cohort will receive once yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis. | This group includes villages of Kertoharjo and Pabean. This cohort will receive twice yearly MDA (albendazole 400 mg + diethylcarbamazing 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Pekalongan study sites were dropped after the first year follow-up due to lower than expected rates of lymphatic filariasis. | |||||
All Cause Mortality |
||||||||||
| Paga (Annual MDA) | Lewomada (Annual MDA) | Pruda (Semiannual MDA) | Pekalongan (Annual MDA) | Pekalongan (Semiannual MDA) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4456 (0%) | 0/3297 (0%) | 0/4111 (0%) | 0/2757 (0%) | 0/2487 (0%) | |||||
Serious Adverse Events |
||||||||||
| Paga (Annual MDA) | Lewomada (Annual MDA) | Pruda (Semiannual MDA) | Pekalongan (Annual MDA) | Pekalongan (Semiannual MDA) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4456 (0%) | 0/3297 (0%) | 0/4111 (0%) | 0/2757 (0%) | 0/2487 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Paga (Annual MDA) | Lewomada (Annual MDA) | Pruda (Semiannual MDA) | Pekalongan (Annual MDA) | Pekalongan (Semiannual MDA) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4456 (0%) | 0/3297 (0%) | 0/4111 (0%) | 0/2757 (0%) | 0/2487 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT 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 | Peter Fischer |
|---|---|
| Organization | Washington University in St Louis Medical School |
| Phone | +1 (314) 747-5198 |
| pufischer@wustl.edu |
Responsible Party:
Gary Weil, MD,
Professor of Medicine/ Microbiology,
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01905423
Other Study ID Numbers:
- 201103313
First Posted:
Jul 23, 2013
Last Update Posted:
Nov 17, 2020
Last Verified:
Oct 1, 2020