A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs… (NCT03923725) | Clinical Trial Compass
CompletedPhase 3
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.
Burkina Faso, Democratic Republic of the Congo, Guinea2,583 participantsStarted 2020-09-01
Plain-language summary
A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.
Who can participate
Age range6 Months – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, aged ≥6 months to \<12 years (For Gambia, Rwanda sites only: ≥6 months)
* Ability to take oral medication
* Acute uncomplicated P. falciparum monoinfection
* Asexual P. falciparum parasitaemia: 1,000/µL to ≤10% parasitaemia, determined on a peripheral blood film (At Gambia, Rwanda sites only: For subjects ≥12 years - 1000/µL to 200,000/µL)
* Fever defined as ≥ 37.5°C tympanic temperature or a history of fever within the last 24 hours
* Written informed consent by the subject or by parent/guardian in case of children lower than the age of consent and assent if required (per local regulations)
* Willingness and ability of the subjects or parents/guardians to comply with the study protocol for the duration of the study
Exclusion Criteria:
* Signs of severe malaria (adapted from WHO criteria)
* Patients not fulfilling criteria for severe malaria but with another indication for parenteral antimalarial treatment at the discretion of the treating physician
* Haematocrit \<15% at screening (For Gambia, Rwanda sites only: For subjects ≥12 years - Haematocrit \<20% at screening)
* Subjects who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days OR mefloquine or piperaquine within the previous 30 days
* In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 14 days.
* Acute illness other than malaria requiring systemic treatment
* Severe a…
What they're measuring
1
42 days Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR).