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OpenTrials
Completed

NCT Number: NCT01000298

Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

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.

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Key information

Conditions

Kwashiorkor Deficiency Diseases Malnutrition Marasmus Nutrition Disorders Nutritional and Metabolic Diseases Protein Deficiency Protein-Energy Malnutrition Severe Acute Malnutrition

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Louis Nutrition Project

Blantyre, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

liquid placebo medication given twice per day for 7 days

Amoxicillin

Drug

liquid amoxicillin given twice per day for 7 days

cefdinir

Drug

liquid cefdinir given twice per day for 7 days

Other names: Omnicef

Primary outcomes

  1. nutritional recovery

    Time frame: 12 weeks

Secondary outcomes

  1. weight gain

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 23, 2009
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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