The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger
Overview
- Phase
- Not Applicable
- Intervention
- Amoxicillin
- Conditions
- Severe Acute Malnutrition
- Sponsor
- Epicentre
- Enrollment
- 2412
- Locations
- 1
- Primary Endpoint
- Proportion of children discharged from nutritional program as recovered
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Sheila Isanaka
Prinicipal Investigator
Epicentre
Eligibility Criteria
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
Arms & Interventions
Routine antibiotic prescription
Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days)
Intervention: Amoxicillin
No routine antibiotic prescription
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of children discharged from nutritional program as recovered
Time Frame: Until discharge from the nutritional program, an expected average of 5 weeks
Secondary Outcomes
- Hospitalization or death(3 months following enrollment)