Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan Children
TACTKenya
An Open-label Randomised Trial to Assess the Therapeutic Efficacy and Tolerability of Arterolane-piperaquine Plus Single Low Dose Primaquine Versus Arterolane-piperaquine Plus Mefloquine and Single Low Dose Primaquine Versus Artemether-lumefantrine Plus Single Low Dose Primaquine in the Treatment of Uncomplicated Falciparum Malaria in Children in Kenya
1 other identifier
interventional
219
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2018
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 2, 2018
CompletedStudy Start
First participant enrolled
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2019
CompletedSeptember 29, 2021
September 1, 2021
1.2 years
February 1, 2018
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
42-day PCR corrected adequate clinical and parasitological response (ACPR) by day 42 by study arm
42 days
Secondary Outcomes (21)
Parasite clearance half-life
42 days
Parasite reduction rates
24 and 48 hours
Parasite count to fall 50%
42 days
Parasite count to fall 90%
42 days
Fever clearance time
42 days
- +16 more secondary outcomes
Study Arms (3)
Arterolane-piperaquine
ACTIVE COMPARATORArterolane-piperaquine for 3 days
Arterolane-piperaquine+mefloquine
ACTIVE COMPARATORArterolane-piperaquine + mefloquine for 3 days
Artemether-lumefantrine
ACTIVE COMPARATORArtemether-lumefantrine for 3 days
Interventions
Arterolane maleate-piperaquine phosphate tablets (37.5 mg/187.5 mg)
Arterolane maleate-piperaquine phosphate tablets (37.5 mg/187.5 mg) Mefloquine tablets (250 mg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kilifi County Hospital
Kilifi, P.O Box P.O. Box 9, Kenya
Related Publications (1)
Hamaluba M, van der Pluijm RW, Weya J, Njuguna P, Ngama M, Kalume P, Mwambingu G, Ngetsa C, Wambua J, Boga M, Mturi N, Lal AA, Khuroo A, Taylor WRJ, Goncalves S, Miotto O, Dhorda M, Mutinda B, Mukaka M, Waithira N, Hoglund RM, Imwong M, Tarning J, Day NPJ, White NJ, Bejon P, Dondorp AM. Arterolane-piperaquine-mefloquine versus arterolane-piperaquine and artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a single-centre, open-label, randomised, non-inferiority trial. Lancet Infect Dis. 2021 Oct;21(10):1395-1406. doi: 10.1016/S1473-3099(20)30929-4. Epub 2021 Jun 7.
PMID: 34111412DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2018
First Posted
March 2, 2018
Study Start
March 7, 2018
Primary Completion
June 3, 2019
Study Completion
June 3, 2019
Last Updated
September 29, 2021
Record last verified: 2021-09