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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-05-31

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.

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Detailed Description

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Conditions

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Severe Acute Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Routine antibiotic prescription

Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days)

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

80 mg/kg/day for 7 days

No routine antibiotic prescription

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

7 days

Interventions

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Amoxicillin

80 mg/kg/day for 7 days

Intervention Type DRUG

Placebo

7 days

Intervention Type DRUG

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No