Status:
COMPLETED
Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan Children
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Mahidol Oxford Tropical Medicine Research Unit
Conditions:
Plasmodium Falciparum
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief Summary
This open-label randomised controlled clinical trial will compare the safety, tolerability, therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine, arterolane-piperaq...
Eligibility Criteria
Inclusion
- Male or female aged 2 years to \<13-year-old
- Uncomplicated falciparum malaria as defined as:
- Positive blood smear with asexual forms of P. falciparum (may be mixed with non-falciparum species)
- Parasitaemia between 5,000-250,000 parasites/µL
- Fever defined as tympanic temperature \>37.5°C or history of fever within last 48 hours
- Ability to take oral medication
- Willingness and ability to comply with study protocol for study duration
- Written informed consent given to participate in the trial
Exclusion
- Signs of severe/complicated malaria\*
- Any clinical reason suggesting that the child's treatment should be given immediately and not delayed during the transfer to Kilifi County Hospital in the opinion of the treating physician.
- Acute illness other than malaria requiring urgent systemic treatment as assessed by the treating physician
- Previous splenectomy
- Treatment with artemisinin or ACT within the previous 7 days
- Treatment with mefloquine in the 2 months prior to presentation
- Known hypersensitivity or contraindication to arterolane-piperaquine, DHA-piperaquine, artemisinin, mefloquine (epilepsy, major psychiatric illness) or primaquine
- QTc interval \>450 milliseconds at point of presentation
- Known personal or family history of cardiac conduction problems
- Participation within another clinical trial in the previous 3 months
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2019
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT03452475
Start Date
March 7 2018
End Date
June 3 2019
Last Update
September 29 2021
Active Locations (1)
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1
Kilifi County Hospital
Kilifi, Kenya, P.O Box P.O. Box 9