Clinical Trial: The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger

Brief Summary: This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.

Detailed Summary:
Sponsor: Epicentre

Current Primary Outcome: Proportion of children discharged from nutritional program as recovered [ Time Frame: Until discharge from the nutritional program, an expected average of 5 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Hospitalization or death [ Time Frame: 3 months following enrollment ]

Original Secondary Outcome: Same as current

Information By: Epicentre

Dates:
Date Received: May 26, 2012
Date Started: October 2012
Date Completion:
Last Updated: May 20, 2014
Last Verified: May 2014