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Could a simple antibiotic boost recovery from severe malnutrition?

NCT ID NCT01000298

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

2,767 people

The number who actually took part.

Start date

Dec 2009

Finished

May 2011

Lead sponsor

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

6 months to 5 years

Sex

Anyone

Healthy volunteers

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

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

  • St. Louis Nutrition Project

    Blantyre, Malawi

More trials for these conditions

Other studies related to the condition(s) this trial covers.