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The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

NCT01613547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2412

Last updated 2014-05-21

No results posted yet for this study

Summary

This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.

Conditions

  • Severe Acute Malnutrition

Interventions

DRUG

Amoxicillin

80 mg/kg/day for 7 days

DRUG

Placebo

7 days

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • FORSANI

    collaborator UNKNOWN

  • District Sanitaire de Madarounfa, Région de Maradi

    collaborator UNKNOWN

  • Ministere de la Sante Publique du Niger

    collaborator UNKNOWN

  • Bichat Hospital

    collaborator OTHER

  • Epicentre

    lead OTHER

Principal Investigators

  • Sheila Isanaka, ScD · Epicentre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-03-31
Completion
2014-05-31

Countries

  • Niger

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 NCT01613547 on ClinicalTrials.gov