Severe Acute Malnutrition
Conditions
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.
Interventions
DRUGAmoxicillin
80 mg/kg/day for 7 days
DRUGPlacebo
7 days
Sponsors
Medecins Sans Frontieres, Netherlands
FORSANI
District Sanitaire de Madarounfa, Région de Maradi
Ministere de la Sante Publique du Niger
Bichat Hospital
Epicentre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children discharged from nutritional program as recovered | Until discharge from the nutritional program, an expected average of 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization or death | 3 months following enrollment |
Countries
Niger
Outcome results
None listed