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

Launched by LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE · Jun 25, 2014

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility 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