Conditions: Falciparum Parasitaemia
Keywords: Falciparum Parasitaemia, Malaria
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 306
Healthy volunteers: yes

Brief summary:
This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.

Detailed description:
Subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. At the end of the clearance period, subjects free from malaria parasitaemia were randomized and received a loading dose of the study treatment (tafenoquine 200 mg, Mefloquine 250 mg or placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo, respectively) once a week for 24 weeks. After the treatment period subjects attended weekly follow-up safety visits until week 28.

Arms:
arm 1: Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks. arm 2: Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks. arm 3: Placebo

Interventions: intervention 1: Tafenoquine intervention 2: Mefloquine intervention 3: Placebo
Intervention descriptions: intervention 1: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks. intervention 2: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks. intervention 3: Placebo for three days followed by placebo once a week for 24 weeks

Protocol document: