Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effectiveness of Oral Antibiotics in the Community-based Treatment of Severe Acute Malnutrition in Malawian Children

Washington University School of Medicine1 site in 1 country2,700 target enrollmentDecember 2009

ConditionsKwashiorkor Marasmus

InterventionsPlacebo Amoxicillin Cefdinir

DrugsPlacebo Amoxicillin Cefdinir

Overview

Phase: Not Applicable
Intervention: Placebo
Conditions: Kwashiorkor
Sponsor: Washington University School of Medicine
Enrollment: 2700
Locations: 1
Primary Endpoint: nutritional recovery
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

May 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Eligibility Criteria

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