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This study compared a triple artemisinin-based combination therapy (AL+AQ) with the standard two-drug therapy (AL) in malaria patients in Cambodia and Vietnam. It enrolled patients aged 2 to 65 with uncomplicated P. falciparum malaria confirmed by blood smear. The trial was conducted in Phase 3 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: * Male or female, aged from 2 years to 65 years old * Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species) * Asexual P. falciparum parasitaemia: 16 to 200,000/microlitre, determined on a thin or thick blood film * Fever defined as \> 37.5°C tympanic temperature or a history of fever within the last 24 hours * Written informed consent (by parent/guardian in case of children) * Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study Exclusion Criteria: * Signs of severe/complicated malaria * Haematocrit \< 25% or Hb \< 8 g/dL at screening * Acute illness other than malaria requiring treatment * For females: pregnancy, breast feeding * Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days * History of allergy or known contraindication to artemisinins, lumefantrine or amodiaquine * Previous splenectomy * corrected QT interval \> 450 milliseconds at moment of presentation * Documented or claimed history of cardiac conduction problems * Previous participation in the current study or another study in the previous 3 months