Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan Children (TACTKenya)

University of Oxford

Status and phase: Completed; Phase 3

Conditions: Plasmodium Falciparum

Treatments: Drug: Arterolane-piperaquine; Drug: Artemether-lumefantrine; Drug: Arterolane-piperaquine+mefloquine

Study type: Interventional

Funder types: Other

Identifiers

NCT03452475

MAL17009

Details and patient eligibility

About

This open-label randomised controlled clinical trial will compare the safety, tolerability, therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine, arterolane-piperaquine plus mefloquine versus artemether-lumefantrine.in children with uncomplicated falciparum malaria in Kilifi, Kenya. This study will also provide an up to date insight on the current presence of antimalarial resistance in this site.

In addition, all children will be treated with a single low dose of primaquine, dosing is age based.

The investigators will recruit 219 patients aged 2 years to 12 years with acute uncomplicated falciparum malaria in Kilifi County Hospital.

Enrollment: 219 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female aged 2 years to <13-year-old

2. 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

3. Ability to take oral medication

4. Willingness and ability to comply with study protocol for study duration

5. Written informed consent given to participate in the trial

Exclusion criteria

1. Signs of severe/complicated malaria*
2. 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.
3. Acute illness other than malaria requiring urgent systemic treatment as assessed by the treating physician
4. Previous splenectomy
5. Treatment with artemisinin or ACT within the previous 7 days
6. Treatment with mefloquine in the 2 months prior to presentation
7. Known hypersensitivity or contraindication to arterolane-piperaquine, DHA-piperaquine, artemisinin, mefloquine (epilepsy, major psychiatric illness) or primaquine
8. QTc interval >450 milliseconds at point of presentation
9. Known personal or family history of cardiac conduction problems
10. Participation within another clinical trial in the previous 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 3 patient groups

Arterolane-piperaquine

Active Comparator group

Description:

Arterolane-piperaquine for 3 days

Treatment:

Drug: Arterolane-piperaquine

Arterolane-piperaquine+mefloquine

Active Comparator group

Description:

Arterolane-piperaquine + mefloquine for 3 days

Treatment:

Drug: Arterolane-piperaquine+mefloquine

Artemether-lumefantrine

Active Comparator group

Description:

Artemether-lumefantrine for 3 days

Treatment:

Drug: Artemether-lumefantrine