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New malaria drug combo shows promise in kids

NCT ID NCT04009343

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how two different malaria drug combinations work in children with uncomplicated malaria in Zambia. The goal was to see how well the drugs clear malaria parasites from the blood and prevent new infections for up to 9 weeks. About 182 children took part, and researchers measured treatment success and reinfection rates.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 182 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 59 months

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: * Weight ≥10 kg * Any indication for malaria diagnostic testing as determined by a treating provider (e.g., fever or history of fever) * P. falciparum parasitemia (by microscopy) of any density not meeting criteria for severe malaria * Ability to swallow oral medication * Ability and willingness of parents or guardians to comply with study protocol for the duration of the study and to comply with the study follow-up visit schedule * Residence within hospital catchment area * Signed informed consent obtained from a legal representative of the participant Exclusion Criteria: * Complicated or severe falciparum malaria as defined by WHO criteria * Hemoglobin concentration \< 7 g/dL * Use of any drug with antimalarial activity within the prior 4 weeks * History of hypersensitivity reaction or intolerance to AL or DP * Co-infection with Plasmodium spp. other than P. falciparum as determined by microscopy * Confirmed or suspected concurrent acute infection other than malaria (e.g. measles, acute lower respiratory tract infection) * Current therapy with QT interval-prolonging agents * Family history of sudden cardiac death or personal history of cardiac disease * Residence outside the study area, or plan to leave the study area * Residence in foster care or otherwise under government supervision * Previous enrollment in the study, or enrollment in any other investigational drug trial during the previous 30 days * Presence of any other condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data

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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

  • Tropical Diseases Research Centre

    Ndola, Copperbelt, Zambia