A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia)

PHASE3CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

January 6, 2023

Study Completion Date

January 28, 2023

Conditions
Plasmodium Falciparum Malaria (Uncomplicated)
Interventions
DRUG

Artemether-lumefantrine+amodiaquine

"AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.~The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days.~AQ: Amodiaquine is available as dispersible tablets of 40 mg. The weight-based treatment schedule aims for a dosage of approximately 10mg (4.5-15mg)/kg/day amodiaquine for three days."

DRUG

Artemether-lumefantrine+placebo

"AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.~The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days.~PBO: Placebo tablets for amodiaquine are identical in size, shape and color to the amodiaquine tablets."

DRUG

Artesunate-mefloquine+piperaquine

"AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day.~MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day.~PPQ: Piperaquine will be administered according to an optimised dosing schedule using tablets of 160 or 500 mg of piperaquine tetraphosphate. The weight-based treatment aims for a dosage of approximately~* 24 mg/kg/day in patients \<25 kg (range 16.0 - 32.0 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 20 - 32 mg/kg per day.~* 18 mg/kg/day in patients ≥25 kg (range 15.0 - 29.4 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 16 - 27 mg/kg per day."

DRUG

Artesunate-mefloquine+placebo

"AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day.~MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day.~PBO: Placebo tablets for piperaquine are identical in size, shape and colour to the piperaquine tablets."

Trial Locations (3)

1803

Siem Pang Health Center, Siem Pang

150501

Kravanh Referral Hospital, Phnum Kravanh

Unknown

Ramu Upazilla Health Complex, Cox’s Bāzār

All Listed Sponsors
collaborator

Mahidol Oxford Tropical Medicine Research Unit

OTHER

lead

University of Oxford

OTHER