Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

Washington University School of Medicine2,700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,700

Conditions

Kwashiorkor Marasmus

Interventions

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

nutritional recovery

Time frame: 12 weeks

Secondary Outcomes

weight gain