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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2016
• Main ID: NCT02654730
• Date of registration: 05/01/2016
• Prospective Registration: No
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia SAFEPRIM-II
• Scientific title: Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia
• Date of first enrolment: December 2015
• Target sample size: 61
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02654730
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Gambia

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficient

Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD normal

Drug: Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficient

Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficient

Drug: Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD normal

Primary Outcome(s)

Haemoglobin concentration relative to baseline value as measured by HemoCue [Time Frame: 28 days]

Secondary Outcome(s)

Biochemistry abnormalities during follow-up: potassium [Time Frame: 28 days]

Haematology abnormalities during follow-up: red cell distribution width (RDW) measured in venous blood samples by full blood count analysis [Time Frame: 28 days]

Biochemistry abnormalities during follow-up: bilirubin concentration [Time Frame: 28 days]

Biochemistry abnormalities during follow-up: lactate dehydrogenase [Time Frame: 28 days]

Haematology abnormalities during follow-up: leukocyte count measured in venous blood samples by full blood count analysis [Time Frame: 28 days]

Biochemistry abnormalities during follow-up: creatinine [Time Frame: 28 days]

Haematology abnormalities during follow-up: mean corpuscular volume (MCV) measured in venous blood samples by full blood count analysis [Time Frame: 28 days]

Number of participants with treatment-related adverse events graded and evaluated in terms of relatedness [Time Frame: 28 days]

Haematology abnormalities during follow-up: haptoglobin concentration measured in venous blood samples by full blood count analysis [Time Frame: 28 days]

Secondary ID(s)

SAFEPRIM-II

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical Research Council Unit, The Gambia