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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Centre national de recherche et de formation sur le paludisme; University Medical Center Nijmegen
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine; Primaquine

Criteria

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