Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)

Evaluation of the Safety of Primaquine in Combination With Artemether-lumefantrine in Glucose-6-phosphate Dehydrogynase Deficient Males With an Asymptomatic Malaria Infection in Burkina Faso (SAFEPRIM)

The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.

Inclusion Criteria:

1. Male gender
2. Age ≥18 years and ≤45 years
3. BMI ≥16
4. P. falciparum parasitaemia at any density
5. G6PD deficiency by Beutler Fluorescent Spot test for intervention groups and control group receiving AL only (N=50)
6. G6PD normal activity by Beutler Fluorescent Spot test for control groups (N=20)
7. Informed consent by participant

Exclusion Criteria:

1. Enrolled in another clinical trial
2. Fever >37.5°C (tympanic) or history of fever in the last 24 hours
3. Evidence of severe illness / danger signs or active infection other than malaria
4. Known allergy to study medications
5. Hb <11 g/dL
6. Antimalarials taken within the last 2 weeks
7. PQ taken within the last 4 weeks and blood transfusion within the last 90 days
8. Non-falciparum malaria co-infection
9. Current use of tuberculosis or anti-retroviral medication, sulphonamides, dapsone, nitrofurantoin, , nalidixic acid, ciprofloxacin, , methylene blue, toluidine blue phenazopyridine and co-trimoxazole.
10. History of severe chronic illness