Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

July 1, 2011 updated by: Washington University School of Medicine

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi
        • St. Louis Nutrition Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
liquid placebo medication given twice per day for 7 days
EXPERIMENTAL: Amoxicillin
Drug: Amoxicillin
liquid amoxicillin given twice per day for 7 days
EXPERIMENTAL: cefdinir
Drug: Cefdinir
liquid cefdinir given twice per day for 7 days
Other Names:
  • Omnicef

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
nutritional recovery
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
weight gain
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Mark J. Manary, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (ESTIMATE)

October 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 1, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MJM-antibiotics

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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