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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G6PD deficient 0.25 mg/kg PQ + AL

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

G6PD deficient receiving AL only

G6PD deficient males receiving Artemether-Lumefantrine (AL) combination

Group Type ACTIVE_COMPARATOR

Artemether-Lumefantrine (AL) combination

Intervention Type DRUG

G6PD normal 0.25 mg/kg PQ + AL

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

G6PD normal 0.4 mg/kg PQ + AL

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

G6PD-deficient 0.4 mg/kg PQ + AL

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Artemether-Lumefantrine (AL) combination

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes