Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

NCT ID: NCT01000298

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-05-31

Brief Summary

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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

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Conditions

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Kwashiorkor Marasmus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

liquid placebo medication given twice per day for 7 days

Amoxicillin

Group Type EXPERIMENTAL

Amoxicillin

Intervention Type DRUG

liquid amoxicillin given twice per day for 7 days

cefdinir

cefdinir

Group Type EXPERIMENTAL

Cefdinir

Intervention Type DRUG

liquid cefdinir given twice per day for 7 days

Interventions

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Placebo

liquid placebo medication given twice per day for 7 days

Intervention Type DRUG

Amoxicillin

liquid amoxicillin given twice per day for 7 days

Intervention Type DRUG

Cefdinir

liquid cefdinir given twice per day for 7 days

Intervention Type DRUG

Other Intervention Names

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Omnicef

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Washington Univeristy in St. Louis

Principal Investigators

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Mark J. Manary, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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St. Louis Nutrition Project

Blantyre, , Malawi

Site Status

Countries

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Malawi

References

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Trehan I, Goldbach HS, LaGrone LN, Meuli GJ, Wang RJ, Maleta KM, Manary MJ. Antibiotics as part of the management of severe acute malnutrition. Malawi Med J. 2016 Sep;28(3):123-130.

Reference Type DERIVED
PMID: 27895846 (View on PubMed)

Trehan I, Goldbach HS, LaGrone LN, Meuli GJ, Wang RJ, Maleta KM, Manary MJ. Antibiotics as part of the management of severe acute malnutrition. N Engl J Med. 2013 Jan 31;368(5):425-35. doi: 10.1056/NEJMoa1202851.

Reference Type DERIVED
PMID: 23363496 (View on PubMed)

Other Identifiers

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MJM-antibiotics

Identifier Type: -

Identifier Source: org_study_id

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