Kwashiorkor, Marasmus
Conditions
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.
Interventions
DRUGPlacebo
liquid placebo medication given twice per day for 7 days
DRUGAmoxicillin
liquid amoxicillin given twice per day for 7 days
DRUGCefdinir
liquid cefdinir given twice per day for 7 days
Sponsors
Washington University School of Medicine
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 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| nutritional recovery | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| weight gain | 12 weeks |
Countries
Malawi
Outcome results
None listed