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Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

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ClinicalTrials.gov Identifier: NCT01000298
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date July 6, 2011
Study Start Date  ICMJE December 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
nutritional recovery [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01000298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
weight gain [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Kwashiorkor
  • Marasmus
Intervention  ICMJE
  • 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
    Other Name: Omnicef
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Amoxicillin
    Intervention: Drug: Amoxicillin
  • Experimental: cefdinir
    cefdinir
    Intervention: Drug: Cefdinir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
2700
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000298
Other Study ID Numbers  ICMJE MJM-antibiotics
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Mark J. Manary, Washington Univeristy in St. Louis
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark J. Manary, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP