Effectiveness of Oral Antibiotics in the Treatment of Sev... | NCT01000298

Studies
Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

NCT01000298

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Jul 6, 2011Estimated

Enrollment

2,700Estimated

Phase

Not Applicable

Conditions

Kwashiorkor
Marasmus

Interventions

Placebo
Amoxicillin
Cefdinir

Countries

Malawi

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Oct 22, 2009

First Submission Date that Met QC Criteria

Oct 22, 2009

First Posted Date

Oct 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2011

Last Update Posted Date

Jul 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Amoxicillin	Experimental		Drug: Amoxicillin
cefdinir	Experimental	cefdinir	Drug: Cefdinir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	liquid placebo medication given twice per day for 7 days	Placebo

Measure	Description	Time Frame
nutritional recovery		12 weeks

Measure	Description	Time Frame
weight gain		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark J. Manary, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Louis Nutrition Project		Blantyre			Malawi

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27895846	Derived	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.
23363496	Derived	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.

ID	Term
D007732	Kwashiorkor
D011502	Protein-Energy Malnutrition

ID	Term
D000067011	Severe Acute Malnutrition
D044342	Malnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769