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

Phase 2

Completed

• Conditions: Malaria
• Interventions: Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine; Drug: Artemether-Lumefantrine (AL) combination; Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine

• Registration Number: NCT02174900
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Study Start: 2014-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G6PD deficient 0.25 mg/kg PQ + AL	Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine	G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
G6PD deficient receiving AL only	Artemether-Lumefantrine (AL) combination	G6PD deficient males receiving Artemether-Lumefantrine (AL) combination
G6PD normal 0.25 mg/kg PQ + AL	Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine	G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
G6PD normal 0.4 mg/kg PQ + AL	Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine	G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
G6PD-deficient 0.4 mg/kg PQ + AL	Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine	G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine

Primary Outcome Measures

Name	Time	Method
Haemoglobin concentration relative to baseline value	28 days	Haemoglobin concentration relative to baseline value

Secondary Outcome Measures

Name	Time	Method
Gametocyte clearance time	14 days	Gametocyte clearance time

Trial Locations

Locations (1)

Centre National de Recherche et de Formation sur le Paludisme; 🇧🇫 Ouagadougou, Burkina Faso