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Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000298
First Posted: October 23, 2009
Last Update Posted: July 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Washington University School of Medicine
  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: Quadruple (Participant, Care Provider, 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:


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

Primary Outcome Measures:
  • nutritional recovery [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • weight gain [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 22, 2009
First Posted: October 23, 2009
Last Update Posted: July 6, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Kwashiorkor
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases
Anti-Bacterial Agents
Amoxicillin
Cefdinir
Anti-Infective Agents