A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Mahidol Oxford Tropical Medicine Research Unit
• Treatments: Amodiaquine; Artemether; Artemether, Lumefantrine Drug Combination; Artemisinine; Artemisinins; Artesunate; Lumefantrine; Mefloquine; Piperaquine

Criteria

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 acute malnutrition (in Niger only - only those patients with Severe Acute Malnutrition and complications requiring inpatient nutritional treatment will be excluded)

• Known HIV infection

• Known tuberculosis infection

• For females: post-menarche (For Gambia, Rwanda sites only: females who are pregnant, trying to get pregnant or are lactating)

• History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy

• Previous splenectomy

• Enrolment in DeTACT in the previous 3 months

• Participation in another interventional study in the previous 3 months