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

Study Overview
=================
Brief 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.

Official 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)

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
* Drug: Artemether-Lumefantrine (AL) combination
* Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male gender Age ≥18 years and ≤45 years BMI ≥16 P. falciparum parasitaemia at any density G6PD deficiency by Beutler Fluorescent Spot test for intervention groups and control group receiving AL only (N=50) G6PD normal activity by Beutler Fluorescent Spot test for control groups (N=20) Informed consent by participant Exclusion Criteria: Enrolled in another clinical trial Fever >37.5°C (tympanic) or history of fever in the last 24 hours Evidence of severe illness / danger signs 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 Non-falciparum malaria co-infection 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G6PD deficient 0.25 mg/kg PQ + AL<br>G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine | Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine<br> <br> |
| Active Comparator: G6PD deficient receiving AL only<br>G6PD deficient males receiving Artemether-Lumefantrine (AL) combination | Drug: Artemether-Lumefantrine (AL) combination<br> <br> |
| Active Comparator: G6PD normal 0.25 mg/kg PQ + AL<br>G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine | Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine<br> <br> |
| Active Comparator: G6PD normal 0.4 mg/kg PQ + AL<br>G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine | Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine<br> <br> |
| Experimental: G6PD-deficient 0.4 mg/kg PQ + AL<br>G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine | Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin concentration relative to baseline value | Haemoglobin concentration relative to baseline value | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gametocyte clearance time | Gametocyte clearance time | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
G6PD deficiency, safety, transmission