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This study assessed the safety of the current standard treatments used for malaria (chloroquine, Artemether-lumefantrine, Primaquine) and the G6PD status of patients in south-east Bangladesh. It included patients aged 12 months and over with P. vivax or P. falciparum infection. It was conducted in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Age ≥ 12 months * P. vivax or P. falciparum monoinfection or P.v. / P.f. mixed infection * Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs * Ability to swallow oral medication. * Ability and willingness to comply with the study protocol for the duration of the study * Informed consent/assent from the patient or from a parent or guardian in the case of children. Exclusion Criteria: * Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO * Presence of severe malnutrition * Acute anaemia \<8g/dL * Regular medication, which may interfere with antimalarial pharmacokinetics * History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s) * A positive pregnancy test or lactating