Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Intervention: ACT; TACT
Intervention description: Artemether-lumefantrine (20/120 mg) as a fixed dose combination twice daily for 3 days according to weight plus low dose primaquine at hour 24; Artemether-lumefantrine (20/120 mg) as a fixed dose combination twice daily for 3 days according to weight plus Amodiaquine (150mg) twice daily for 3 days according to weight plus low dose primaquine at hour 24
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open-label randomised trial
Masking: None (Open Label)
Enrollment: 310.0
Sex: All
Minimum age: 2 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Malaria, Falciparum; Malaria; Protozoan Infections; Lumefantrine; Artemether; Amodiaquine; Piperaquine; Artemether-lumefantrine combination; Artemisinins; Dihydroartemisinin; Mefloquine; Artemisinin; Antimalarials; Antiparasitic Agents; Anti-Infective Agents; ACT; TACT; Triple ACT(s); Resistance; Antimalarial resistance; Cardiotoxicity; Safety; Tolerability; Efficacy

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
    

Eligibility 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