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

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Malaria

Treatments: Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine; Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine; Drug: Artemether-Lumefantrine (AL) combination

Study type: Interventional

Funder types: Other

Identifiers

NCT02174900

SAFEPRIM

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 5 patient groups

G6PD deficient 0.25 mg/kg PQ + AL

Experimental group

Description:

G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine

Treatment:

Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine

G6PD deficient receiving AL only

Active Comparator group

Description:

G6PD deficient males receiving Artemether-Lumefantrine (AL) combination

Treatment:

Drug: Artemether-Lumefantrine (AL) combination

G6PD normal 0.25 mg/kg PQ + AL

Active Comparator group

Description:

G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine

Treatment:

Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine

G6PD normal 0.4 mg/kg PQ + AL

Active Comparator group

Description:

G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine

Treatment:

Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine

G6PD-deficient 0.4 mg/kg PQ + AL

Experimental group

Description:

G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine

Treatment:

Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine