NCT01000298

Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,700 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kwashiorkor
• Marasmus

Interventions

Type	Name	Description
DRUG	Placebo	liquid placebo medication given twice per day for 7 days
DRUG	Amoxicillin	liquid amoxicillin given twice per day for 7 days
DRUG	Cefdinir	liquid cefdinir given twice per day for 7 days

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-10-23
• Last updated: 2011-07-06

Locations

1 site across 1 country: Malawi