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Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

NCT01000298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2700

Last updated 2011-07-06

No results posted yet for this study

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.

Conditions

  • Kwashiorkor
  • Marasmus

Interventions

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

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark J. Manary, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01000298 on ClinicalTrials.gov