The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

Study Overview
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Brief Summary
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This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.

Official Title
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The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger

Conditions
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Severe Acute Malnutrition

Intervention / Treatment
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* Drug: Amoxicillin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 6 to 59 months MUAC < 11.5 cm or WHZ < -3 Absence of bipedal edema Absence of current illness requiring inpatient care Eligible for new admission for outpatient nutritional therapy for SAM at 3 CRENAS in Madarounfa operated by FORSANI Absence of current clinical illness requiring prescription of specific antibiotic therapy and decision by the study physician to use a specific antimicrobial drug on admission Written consent of parent or caregiver Residence within Niger Exclusion Criteria: Age < 6 months or > 59 months MUAC ≥ 11.5 cm and WHZ ≥ -3 Presence of bipedal edema Presence of current illness requiring inpatient care Decision by the study physician to use a specific different antimicrobial drug on admission Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection Treatment with any antibiotic within 7 days Admission to any nutritional program for the treatment of SAM within 3 months Known contraindication / hypersensitivity to amoxicillin

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine antibiotic prescription<br>Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days) | Drug: Amoxicillin<br>* 80 mg/kg/day for 7 days<br>|
| Placebo Comparator: No routine antibiotic prescription<br> | Drug: Placebo<br>* 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children discharged from nutritional program as recovered |  | Until discharge from the nutritional program, an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization or death |  | 3 months following enrollment |