Could a simple antibiotic boost recovery from severe malnutrition?
NCT ID NCT01000298
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial tests whether giving oral antibiotics alongside a therapeutic food improves recovery in young children with severe acute malnutrition (kwashiorkor or marasmus). Children aged 6 months to 5 years who qualify for home-based feeding will receive either amoxicillin, cefdinir, or a placebo for 7 days. The study compares nutritional recovery and weight gain among the groups to see if antibiotics add any benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral antibiotics (amoxicillin or cefdinir) given alongside ready-to-use therapeutic food
- What this could lead to
- If antibiotics help, this could lead to a simple, low-cost addition to home-based treatment for severe malnutrition, potentially saving many young lives.
- What could go wrong
- The trial is testing a hypothesis that antibiotics may not change recovery rates. Risks include antibiotic side effects and the possibility that adding drugs offers no benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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2,767 people
The number who actually took part.
- Start date
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Dec 2009
- Finished
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May 2011
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 5 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Louis Nutrition Project
Blantyre, Malawi
More trials for these conditions
Other studies related to the condition(s) this trial covers.