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Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01000298
First received: October 22, 2009
Last updated: July 1, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Kwashiorkor
Marasmus
 Drug: Placebo
Drug: Amoxicillin
Drug: Cefdinir

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • nutritional recovery [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight gain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 2700
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
cefdinir
 Drug: Cefdinir
liquid cefdinir given twice per day for 7 days
Other Name: Omnicef

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000298

Locations
Malawi
St. Louis Nutrition Project
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Mark J. Manary, MD Washington University School of Medicine
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Mark J. Manary, Washington Univeristy in St. Louis
ClinicalTrials.gov Identifier: NCT01000298     History of Changes
Other Study ID Numbers: MJM-antibiotics
Study First Received: October 22, 2009
Last Updated: July 1, 2011
Health Authority: Malawi: College of Medicine Research and Ethics Committee
United States: Institutional Review Board

Additional relevant MeSH terms:
Kwashiorkor
Protein-Energy Malnutrition
Malnutrition
Protein Deficiency
Deficiency Diseases
Nutrition Disorders
 Amoxicillin
Anti-Bacterial Agents
Cefdinir
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013