Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia

• Status: Terminated
• Trial end date: 2016-12-01
• 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 dihydroartemisinin-piperaquine in G6PD deficient males.

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

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: Medical Research Council Unit, The Gambia
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine; Primaquine

Criteria

Inclusion Criteria:

• G6PD deficiency by fluorescent Spot test (for intervention groups and control group receiving DHA-PPQ only (N=50)

• G6PD normal activity by fluorescent Spot test for control groups (N=20)

• Informed consent by participant or caregiver (an assent is required for those 12-17 years)

Exclusion Criteria:

• Enrolled in another clinical trial

• Fever: temperature >37.5°C (axillary) or history of fever in the last 24 hours

• Evidence of severe illness or active infection other than malaria

• Known allergy to study medications

• Hb <11 g/dL

• Antimalarials taken within the last 2 weeks

• PQ taken within the last 4 weeks and blood transfusion within the last 90 days

• Current use of tuberculosis or anti-retroviral medication, sulphonamides, dapsone, nitrofurantoin, nalidixic acid, ciprofloxacin, methylene blue, toluidine blue, phenazopyridine and co-trimoxazole.

• History of severe chronic illness