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Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

Primary Purpose

Kwashiorkor, Marasmus

Status

Completed

Phase

Not Applicable

Locations

Malawi

Study Type

Interventional

Intervention

Placebo

Amoxicillin

Cefdinir

About this trial

This is an interventional treatment trial for Kwashiorkor

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Louis Nutrition Project

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Amoxicillin

cefdinir

Arm Description

cefdinir

Outcomes

Primary Outcome Measures

nutritional recovery

Secondary Outcome Measures

weight gain

Full Information

NCT ID

NCT01000298

First Posted

October 22, 2009

Last Updated

July 1, 2011

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01000298

Brief Title

Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kwashiorkor, Marasmus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Amoxicillin

Arm Type

Experimental

Arm Title

cefdinir

Arm Type

Experimental

Arm Description

cefdinir

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

liquid placebo medication given twice per day for 7 days

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Intervention Description

liquid amoxicillin given twice per day for 7 days

Intervention Type

Drug

Intervention Name(s)

Cefdinir

Other Intervention Name(s)

Omnicef

Intervention Description

liquid cefdinir given twice per day for 7 days

Primary Outcome Measure Information:

Title

nutritional recovery

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

weight gain

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark J. Manary, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Louis Nutrition Project

City

Blantyre

Country

Malawi

12. IPD Sharing Statement

Citations:

PubMed Identifier

27895846

Citation

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.

Results Reference

derived

PubMed Identifier

23363496

Citation

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.

Results Reference

derived

Learn more about this trial

Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

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