Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

NCT01000298 | Completed DMC

• 1 other identifier: MJM-antibiotics
• Study Type: interventional
• Target: 2,700
• Locations: 1 country
• Sites: 1

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.

Conditions

Kwashiorkor; Marasmus

Outcome Measures

Primary Outcomes (1)

• nutritional recovery

  12 weeks

Secondary Outcomes (1)

• weight gain

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Amoxicillin

EXPERIMENTAL

Drug: Amoxicillin

cefdinir

EXPERIMENTAL

cefdinir

Drug: Cefdinir

Interventions

Placebo DRUG

liquid placebo medication given twice per day for 7 days

Placebo

Amoxicillin DRUG

liquid amoxicillin given twice per day for 7 days

Amoxicillin

Cefdinir DRUG

liquid cefdinir given twice per day for 7 days

Also known as: Omnicef

cefdinir

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• months - 5 years old
• Kwashiorkor or Marasmus
• Qualifies for home-based therapeutic feeding with RUTF

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St. Louis Nutrition Project

Blantyre, Malawi

Location

Related Publications (2)

• 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.

  PMID: 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. N Engl J Med. 2013 Jan 31;368(5):425-35. doi: 10.1056/NEJMoa1202851.

  PMID: 23363496 DERIVED

MeSH Terms

Conditions

Kwashiorkor; Protein-Energy Malnutrition

Interventions

Amoxicillin; Cefdinir

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Protein Deficiency; Deficiency Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephalosporins; Thiazines

Study Officials

• Mark J. Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 6, 2011

Record last verified: 2011-07

Locations

MA (1)