Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition
Not Applicable
Completed
- Conditions
- KwashiorkorMarasmus
- Interventions
- Registration Number
- NCT01000298
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The need for oral antibiotics as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not been studied in a prospective trial. This study will compare the recovery rates of children with SAM treated at home with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed antibiotics as part of their outpatient case management. The investigators hypothesize that there will be no significant difference in rates of recovery between children who receive and children who do not receive antibiotics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2700
Inclusion Criteria
- 6 months - 5 years old
- Kwashiorkor or Marasmus
- Qualifies for home-based therapeutic feeding with RUTF
Exclusion Criteria
- Obvious congenital or other malformation that makes child a poor candidate for home-based feeding with RUTF
- Unable to consume test-dose of RUTF in clinic
- Parent refusal to participate and return for follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Amoxicillin Amoxicillin - cefdinir Cefdinir cefdinir
- Primary Outcome Measures
Name Time Method nutritional recovery 12 weeks
- Secondary Outcome Measures
Name Time Method weight gain 12 weeks
Trial Locations
- Locations (1)
St. Louis Nutrition Project
🇲🇼Blantyre, Malawi