Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
Sponsor
Coordinación de Investigación en Salud, Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT03019965
Collaborator
Instituto Mexicano del Seguro Social (Other), Hospital Infantil de Mexico Federico Gomez (Other), Hospital Regional de Alta Especialidad del Bajio (Other)
426
2
6
35.9
213
5.9
Study Details
Study Description
Brief Summary
This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis. Half of participants will receive piperacillin/tazobactam, imipenem or meropenem in continuous or extended infusion, while the other half will receive piperacillin/tazobactam, imipenem or meropenem in intermittent infusion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Sepsis is the leading cause of morbidity and mortality in hospitalised patients globally. Betalactams are time-dependent antibiotics, and so, the duration of time for which the free drug plasma concentration remains above the minimum inhibitory concentration (fT > MIC) is the pharmacokinetic/pharmacodynamic index associated with bacterial killing and clinical improvement. Numerous studies have demonstrated that continuous infusion (infusion in 24 hours) and extended infusion (through prolonging the infusion time to greater than 3 hours) allows the maintenance of concentrations above the MIC for a longer period of time within the dosing interval (30 minute or 1 hour), and so, capitalises on the pharmacodynamic properties of betalactams and maximises bacterial killing, therefore potentially improving clinical outcomes. In adult patients, the several studies suggest that prolonged infusion may offer clinical benefits and significant reduction in mortality without increasing the risk of toxicity, however, there is limited information about these dosing strategies in pediatric patients.
Study Design
Study Type:
Interventional
Actual Enrollment
:
426 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of the Administration of Betalactam Antibiotics in Continuous or Extended Infusion Compared to Intermittent Infusion in Patients With Sepsis in Two Pediatric Third-level Care Hospitals
Actual Study Start Date
:
Feb 1, 2017
Actual Primary Completion Date
:
Dec 30, 2019
Actual Study Completion Date
:
Jan 30, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intermittent Piperacillin/tazobactam Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours. |
Drug: Intermittent Piperacillin/tazobactam
Piperacillin/tazobactam administered in 30 minutes infusion.
Other Names:
|
| Experimental: Continuous Piperacillin/tazobactam Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature. |
Drug: Continuous Piperacillin/tazobactam
Piperacillin/tazobactam administered in 24 hours infusion.
Other Names:
|
| Active Comparator: Intermittent Imipenem Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours. |
Drug: Intermittent Imipenem
Imipenem administered in 60 minutes infusion.
Other Names:
|
| Experimental: Extended Imipenem Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature. |
Drug: Extended Imipenem
Imipenem administered in 6 hours infusion.
Other Names:
|
| Active Comparator: Intermittent Meropenem Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours. |
Drug: Intermittent Meropenem
Meropenem administered in 60 minutes infusion.
Other Names:
|
| Experimental: Extended Meropenem Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature. |
Drug: Extended Meropenem
Meropenem administered in 8 hours infusion.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Clinical Response [Number of participants with clinical response at 14 days after antibiotic cessation, up to an average of 28 days or the day of your discharge if this occurred before 14 days after antibiotic cessation.]
Resolution. Disappearance of all signs and symptoms related to the infection. Failure. Insufficient lessening of the signs and symptoms of infection to qualify as improvement, including death or indeterminate (no evaluation possible, for any reason).
Secondary Outcome Measures
- Number of Participants With Adverse Events [Number of participants with adverse events evaluated by an physician at the time of administration of antibiotics, up to an average to 24 hours after the study drug cessation.]
Any harmful, undesirable, potentially serious and life threatening effects occurring during or after administration of the antibiotics proposed in this study (piperacillin / tazobactam, imipenem or meropenem), was evaluated as: none or adverse event classified according to the intensity of the clinical manifestation (severity) as: mild, moderate or severe and for each antibiotic.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Month
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients diagnosed with sepsis, who have been evaluated by an infectious physician and are candidates to receive piperacillin/tazobactam, imipenem or meropenem as empiric treatment.
Exclusion Criteria:
-
Patients with a history of allergy to one or more of the proposed antibiotics.
-
Patients with chronic kidney disease or acute renal failure.
-
Patients with acute liver failure of any cause.
-
Patients in palliative or supportive care only.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Infantil de México Federico Gómez | Mexico | Distrito Federal | Mexico | 06720 |
| 2 | Instituto Mexicano del Seguro Social | Mexico | Distrito Federal | Mexico | 06720 |
Sponsors and Collaborators
- Coordinación de Investigación en Salud, Mexico
- Instituto Mexicano del Seguro Social
- Hospital Infantil de Mexico Federico Gomez
- Hospital Regional de Alta Especialidad del Bajio
Investigators
- Principal Investigator: Yazmín del Carmen Fuentes, Instituto Mexicano del Seguro Social
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Yazmín Del Carmen Fuentes Pacheco,
Pediatric Infectious Disease,
Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT03019965
Other Study ID Numbers:
- 2016-785-099
First Posted:
Jan 13, 2017
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | the pre-specified intent was to only compare "Intermittent" and "Prolonged" Arm/Groups with the grouping of betalactam antibiotics (imipenem, meropenem and piperacillin/tazobactam) |
| Arm/Group Title | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem |
|---|---|---|
| Arm/Group Description | Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours. Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion. Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours. Intermittent Imipenem: Imipenem administered in 60 minutes infusion. Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours. Intermittent Meropenem: Meropenem administered in 60 minutes infusion. | Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature. Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion. Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature. Extended Imipenem: Imipenem administered in 6 hours infusion. Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature. Extended Meropenem: Meropenem administered in 8 hours infusion. |
| Period Title: Overall Study | ||
| STARTED | 211 | 215 |
| COMPLETED | 201 | 202 |
| NOT COMPLETED | 10 | 13 |
Baseline Characteristics
| Arm/Group Title | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | Total |
|---|---|---|---|
| Arm/Group Description | Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours. Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion. Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours. Intermittent Imipenem: Imipenem administered in 60 minutes infusion. Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours. Intermittent Meropenem: Meropenem administered in 60 minutes infusion. | Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature. Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion. Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature. Extended Imipenem: Imipenem administered in 6 hours infusion. Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature. Extended Meropenem: Meropenem administered in 8 hours infusion. | Total of all reporting groups |
| Overall Participants | 201 | 202 | 403 |
| Age (Count of Participants) | |||
| <=18 years |
201
100%
|
202
100%
|
403
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
6
|
6
|
6
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
91
45.3%
|
91
45%
|
182
45.2%
|
| Male |
110
54.7%
|
111
55%
|
221
54.8%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| Mexico |
201
100%
|
202
100%
|
403
100%
|
| Comorbidity (Count of Participants) | |||
| Count of Participants [Participants] |
196
97.5%
|
187
92.6%
|
383
95%
|
| Comorbid conditions (Count of Participants) | |||
| Neoplastic |
125
62.2%
|
133
65.8%
|
258
64%
|
| Gastrointestinal |
20
10%
|
15
7.4%
|
35
8.7%
|
| Neurological |
8
4%
|
11
5.4%
|
19
4.7%
|
| Neonatal |
2
1%
|
3
1.5%
|
5
1.2%
|
| Cardiovascular |
15
7.5%
|
8
4%
|
23
5.7%
|
| Respiratory |
2
1%
|
2
1%
|
4
1%
|
| Hematologic/immunologic |
11
5.5%
|
4
2%
|
15
3.7%
|
| Metabolic |
1
0.5%
|
1
0.5%
|
2
0.5%
|
| Renal |
1
0.5%
|
0
0%
|
1
0.2%
|
| Genetic |
11
5.5%
|
9
4.5%
|
20
5%
|
| Stem cell transplant |
0
0%
|
1
0.5%
|
1
0.2%
|
| Hospital stay prior to enrollment to the study protocol (Count of Participants) | |||
| Count of Participants [Participants] |
113
56.2%
|
122
60.4%
|
235
58.3%
|
| septic shock at enrollment (Count of Participants) | |||
| Count of Participants [Participants] |
49
24.4%
|
61
30.2%
|
110
27.3%
|
| B-lactam antibiotic (Count of Participants) | |||
| piperacillin/tazobactam |
109
54.2%
|
108
53.5%
|
217
53.8%
|
| imipenem |
39
19.4%
|
42
20.8%
|
81
20.1%
|
| meropenem |
53
26.4%
|
52
25.7%
|
105
26.1%
|
| type of infection (Count of Participants) | |||
| febrile neutropenia |
69
34.3%
|
55
27.2%
|
124
30.8%
|
| intraabdominal |
40
19.9%
|
55
27.2%
|
95
23.6%
|
| respiratory tract |
34
16.9%
|
27
13.4%
|
61
15.1%
|
| bacteremia |
30
14.9%
|
35
17.3%
|
65
16.1%
|
| skin and soft tissue |
11
5.5%
|
10
5%
|
21
5.2%
|
| unknown |
11
5.5%
|
14
6.9%
|
25
6.2%
|
| urinary tract |
6
3%
|
6
3%
|
12
3%
|
| Number of participants with organisms identified (Count of Participants) | |||
| Count of Participants [Participants] |
75
37.3%
|
86
42.6%
|
161
40%
|
Outcome Measures
| Title | Number of Participants With Clinical Response |
|---|---|
| Description | Resolution. Disappearance of all signs and symptoms related to the infection. Failure. Insufficient lessening of the signs and symptoms of infection to qualify as improvement, including death or indeterminate (no evaluation possible, for any reason). |
| Time Frame | Number of participants with clinical response at 14 days after antibiotic cessation, up to an average of 28 days or the day of your discharge if this occurred before 14 days after antibiotic cessation. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The efficacy of the maneuver was evaluated by frequency of clinical response and calculation of the absolute risk reduction and the number needed to treat. |
| Arm/Group Title | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem |
|---|---|---|
| Arm/Group Description | Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours. Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion. Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours. Intermittent Imipenem: Imipenem administered in 60 minutes infusion. Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours. Intermittent Meropenem: Meropenem administered in 60 minutes infusion. | Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature. Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion. Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature. Extended Imipenem: Imipenem administered in 6 hours infusion. Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature. Extended Meropenem: Meropenem administered in 8 hours infusion. |
| Measure Participants | 201 | 202 |
| Count of Participants [Participants] |
178
88.6%
|
169
83.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem, Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.156 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Other Statistical Analysis | The efficacy of the maneuver was evaluated by calculating the absolute risk reduction and the number needed to treat. | |
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | Any harmful, undesirable, potentially serious and life threatening effects occurring during or after administration of the antibiotics proposed in this study (piperacillin / tazobactam, imipenem or meropenem), was evaluated as: none or adverse event classified according to the intensity of the clinical manifestation (severity) as: mild, moderate or severe and for each antibiotic. |
| Time Frame | Number of participants with adverse events evaluated by an physician at the time of administration of antibiotics, up to an average to 24 hours after the study drug cessation. |
Outcome Measure Data
| Analysis Population Description |
|---|
| evaluation of the safety of the intervention with analysis of the frequency of adverse events by treatment group |
| Arm/Group Title | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem |
|---|---|---|
| Arm/Group Description | Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours. Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion. Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours. Intermittent Imipenem: Imipenem administered in 60 minutes infusion. Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours. Intermittent Meropenem: Meropenem administered in 60 minutes infusion. | Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature. Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion. Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature. Extended Imipenem: Imipenem administered in 6 hours infusion. Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature. Extended Meropenem: Meropenem administered in 8 hours infusion. |
| Measure Participants | 201 | 202 |
| Count of Participants [Participants] |
1
0.5%
|
3
1.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem, Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.722 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 2.98 | |
| Confidence Interval |
(2-Sided) 95% 0.31 to 28.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | adverse events by the mode of administration: intermittent or prolonged, evaluated during the time of administration, up to an average 24 hours after administration of the antibiotics proposed. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | pre-specified intent was to only compare "Intermittent" and "Prolonged" Arm/Groups with the grouping of antibiotics betalactam (imipenem, meropenem and piperacillin/tazobactam) | |||
| Arm/Group Title | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | ||
| Arm/Group Description | Piperacillin/tazobactam 300mg/kg/day, divided into 4 doses/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 30 minutes infusion every 6 hours. Intermittent Piperacillin/tazobactam: Piperacillin/tazobactam administered in 30 minutes infusion. Imipenem 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes infusion every 6 hours. Intermittent Imipenem: Imipenem administered in 60 minutes infusion. Meropenem 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 60 minutes every 8 hours. Intermittent Meropenem: Meropenem administered in 60 minutes infusion. | Piperacillin/tazobactam initial doses 75mg/kg in 30 minutes infusion, immediately thereafter continue 300mg/kg/day, diluted in 5% glucose solution, at a concentration of 50mg/ml, to be administered in 24 hours infusion every 24 hours, as determined by antibiotic stability at room temperature. Continuous Piperacillin/tazobactam: Piperacillin/tazobactam administered in 24 hours infusion. Imipenem initial doses 20mg/kg in 60 minutes infusion, immediately thereafter continue 80mg/kg/day, divided into 4 doses/day, diluted in 0.9% saline solution, at a concentration of 7mg/ml, to be administered in 6 hours infusion every 6 hours, as determined by antibiotic stability at room temperature. Extended Imipenem: Imipenem administered in 6 hours infusion. Meropenem initial doses 35mg/kg in 60 minutes infusion, immediately thereafter continue 100mg/kg/day, divided into 3 doses/day, diluted in 0.9% saline solution at a concentration of 7mg/ml, to be administered in 8 hours infusion every 8 hours, as determined by antibiotic stability at room temperature. Extended Meropenem: Meropenem administered in 8 hours infusion. | ||
All Cause Mortality |
||||
| Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/201 (8.5%) | 19/202 (9.4%) | ||
Serious Adverse Events |
||||
| Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/201 (0%) | 0/202 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/201 (0.5%) | 3/202 (1.5%) | ||
| Gastrointestinal disorders | ||||
| moderate adverse event | 1/201 (0.5%) | 1 | 3/202 (1.5%) | 3 |
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 | Dr. Yazmín Fuentes |
|---|---|
| Organization | CISMexico |
| Phone | 55276900 ext 22462 |
| yazmin_fuentes@hotmail.com |
Responsible Party:
Yazmín Del Carmen Fuentes Pacheco,
Pediatric Infectious Disease,
Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT03019965
Other Study ID Numbers:
- 2016-785-099
First Posted:
Jan 13, 2017
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021