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New combo drug doses aim to wipe out whipworm in toddlers

NCT ID NCT06184399

Disease control Sponsor: Jennifer Keiser Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether higher doses of ivermectin, combined with albendazole, are safe and effective for treating whipworm infections in children aged 2 to 5 years. The trial involved 260 children in Tanzania and compared different doses of ivermectin, including a new dissolvable tablet. The main goal was to see how many children were cured of the infection after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivermectin and albendazole
What this could lead to
If successful, this could point toward a more effective treatment for whipworm infections in young children, reducing the burden of this parasitic disease.
What could go wrong
This is a Phase 2 dose-ranging trial with 260 children, so results are preliminary. The treatment may not prove more effective than current options, and side effects are possible.

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

260 people

The number who actually took part.

Started

Jun 2024

Finished

Aug 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

2 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: * individuals aged 2-5 years (24-71 months; confirmed by birth certificate or similar document) * having given written informed consent signed by parents/caregivers * being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days) * having at least two out of four Kato-Katz slides positive for T. trichiura at baseline * being able and willing to be examined by a study physician before and after treatment Exclusion Criteria: * presence or signs of major systemic illness, e.g. fever (temporal body temperature of \>38.0°C), severe anaemia (haemoglobin level of \<70 g/l) * history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary) * use of anthelminthic drugs during study period * known allergy to study medication (i.e., ivermectin or albendazole) * being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication * concurrent participation in other clinical trials

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Conditions

The condition(s) this trial relates to.

ancylostomiasis ascariasis Hookworm Infections hookworm infectious disease trichuriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ascariasis Hookworm infections Trichuriasis

Contacts and locations

Locations

  • Public Health Laboratory Ivo de Carneri

    Chake Chake, Tanzania

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