Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

Kwashiorkor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000298
• Other study ID #: MJM-antibiotics
• Status: Completed
• Phase: N/A
• First received: October 22, 2009
• Last updated: July 1, 2011
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2700
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Marasmus

Intervention

Drug:
• Placebo
liquid placebo medication given twice per day for 7 days
• Amoxicillin
liquid amoxicillin given twice per day for 7 days
• Cefdinir
liquid cefdinir given twice per day for 7 days

Locations

Country	Name	City	State
Malawi	St. Louis Nutrition Project	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nutritional recovery		12 weeks	No
Secondary	weight gain		12 weeks	No