Higher dose of schistosomiasis drug shows promise for toddlers
NCT ID NCT03640377
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two doses (40 vs 80 mg/kg) of praziquantel in 354 children aged 1-4 with schistosomiasis in Uganda. The goal was to find the best dose to cure the infection and improve growth and anemia. Currently, praziquantel is not approved for children under 4, and this trial aims to fill that gap.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- praziquantel
- What this could lead to
- If successful, this could lead to better dosing guidelines for young children with schistosomiasis, improving cure rates and reducing disease burden.
- What could go wrong
- This is a Phase II trial with 354 children, so results are still preliminary. Higher doses may cause more side effects, and findings may not apply to all regions or parasite types.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
354 people
The number who actually took part.
- Started
-
Feb 2021
- Finished
-
Jun 2024
- 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
-
12 to 48 months
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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: * S. mansoni infection by urine CCA * Otherwise healthy as determined by history and physical examination conducted by the study physician at the second stage screening * Age 12-48 months inclusive * Parental consent to participate. Exclusion Criteria: * Parental inability to provide informed consent * Significant disease/illness as determined by history or physical exam. This includes a severe acute illness or chronic disease as defined by greater than 3 months duration and significantly impacting a child's daily activities. * Severe wasting as defined by WHZ \< -3, * Severe anemia (hemoglobin \< 7 g/dL) * Exposure to immuno-modulatory therapeutics.
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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
-
London School of Tropical Hygiene and Medicine
London, United Kingdom
-
Medical Research Council
Entebbe, 3FC6+Q3C,, Uganda
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