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

• Status: Recruiting
• Trial end date: 2023-03-30
• 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 (AS-MQ+PPQ) with the ACTs artemether-lumefantrine + placebo (AL+PBO) and artesunate- mefloquine + placebo (AS-MQ+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; Antimalarials; Artemether; Artemether, Lumefantrine Drug Combination; Artesunate; Lumefantrine; Mefloquine; Piperaquine

Criteria

Inclusion Criteria:

• Male or female, >/= 6 months

• Ability to take oral medication

• Acute uncomplicated P. falciparum monoinfection

• Asexual P. falciparum parasitaemia: 96 to 200,000/µL, determined on a peripheral blood film

• 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 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 < 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

• Acute illness other than malaria requiring systemic treatment

• Severe acute malnutrition

• Known HIV infection

• Known tuberculosis infection

• For females: 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

Criteria for severe malaria

• Impaired consciousness (Glasgow Coma Scale, Blantyre Coma Scale)

• Prostration

• Respiratory distress (defined as maximal respiratory rate, by age)

• ≥2 convulsions in the past 24 hours

• Circulatory collapse

• Pulmonary edema

• Abnormal bleeding

• Visible jaundice

• Haemoglobinuria (blackwater)

• Hyperparasitaemia (>10%)