Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

The Washington University

Status: Completed

Conditions: Kwashiorkor; Marasmus

Treatments: Drug: Placebo; Drug: Amoxicillin; Drug: Cefdinir

Study type: Interventional

Funder types: Other

Identifiers

NCT01000298

MJM-antibiotics

Details and patient eligibility

About

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.

Enrollment: 2,700 estimated patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,700 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Amoxicillin

Experimental group

Treatment:

Drug: Amoxicillin

cefdinir

Experimental group

Description:

cefdinir

Treatment:

Drug: Cefdinir