Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam

• Status: Completed
• Trial end date: 2020-03-04
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the ACT artemether-lumefantrine (AL) in uncomplicated falciparum malaria in Cambodia and Vietnam. The estimated total sample size is 600 patients from 2 sites in Cambodia and 2 sites in Vietnam. There are 2 treatment arms Arm 1: Artemether-lumefantrine for 3 days Arm 2: Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. According to the World Health Organization guideline, all patients except children under 10 kilograms will also be treated with a single dose of primaquine as a gametocytocidal treatment.

Funder :Bill & Melinda Gates Foundation (BMGF) Grant reference number: OPP1132628

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

Details

• Lead Sponsor: University of Oxford
• Treatments: Amodiaquine; Antimalarials; Artemether; Artemether-lumefantrine combination; Artemisinins; Lumefantrine; Primaquine

Criteria

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