Sirima SAFEPRIM (started 2014)

Trial name or title	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)
Methods	Phase 2/3 randomized, safety study, parallel assignment, open label. Primary purpose: treatment
Participants	Target sample size (N = 70) in Burkina Faso Inclusion criteria: 1. Male gender 2. Aged ≥ 18 years to ≤ 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
Interventions	1. AL + 0.25 mg/kg PQ 2. AL + 0.4 mg/kg PQ 3. AL combination
Outcomes	Primary outcome: Haemoglobin concentration relative to baseline value (time frame: 28 days) Secondary outcome: Gametocyte clearance time (time frame: 14 days)
Starting date	Date of registration 11 June 2014. Date of first enrolment October 2014
Contact information	s.sirima.cnlp@fasonet.bf + 226 50 32 46 95/96 (Sodiomon Sirima, MD, PhD) teun.bousema@lshtm.ac.uk +31243613663 (Teun Bousema, PhD)
Notes	ClinicalTrials.gov identifier: NCT02174900 Primary sponsor: London School of Hygiene and Tropical Medicine Secondary sponsors: Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso; University Medical Center Nijmegen