Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2011

Interventions

  • 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

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: Amoxicillin
  • Experimental: cefdinir
    • cefdinir

Clinical Trial Outcome Measures

Primary Measures

  • nutritional recovery
    • Time Frame: 12 weeks

Secondary Measures

  • weight gain
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Professor Mark J. Manary, Washington Univeristy in St. Louis
  • Overall Official(s)
    • Mark J. Manary, MD, Principal Investigator, Washington University School of Medicine

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