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

Not Applicable

Completed

• Conditions: Severe Acute Malnutrition
• Interventions: Drug: Placebo; Drug: Amoxicillin

• Registration Number: NCT01613547
• Lead Sponsor: Epicentre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-26
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Study Start: 2012-10
• Primary Completion: 2014-03
• Status Verified: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2412

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No routine antibiotic prescription	Placebo	-
Routine antibiotic prescription	Amoxicillin	Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days)

Primary Outcome Measures

Name	Time	Method
Proportion of children discharged from nutritional program as recovered	Until discharge from the nutritional program, an expected average of 5 weeks

Secondary Outcome Measures

Name	Time	Method
Hospitalization or death	3 months following enrollment

Trial Locations

Locations (1)

Centres de Récupération et d'Education Nutritionnelle Ambulatoires de Dan Issa, Madarounfa, and Gabi; 🇳🇪 Maradi, Niger