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

Conditions

Malaria

Keywords

G6PD deficiency, safety, transmission

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.

Taylor WR, Naw HK, Maitland K, Williams TN, Kapulu M, D'Alessandro U, Berkley JA, Bejon P, Okebe J, Achan J, Amambua AN, Affara M, Nwakanma D, van Geertruyden JP, Mavoko M, Lutumba P, Matangila J, Brasseur P, Piola P, Randremanana R, Lasry E, Fanello C, Onyamboko M, Schramm B, Yah Z, Jones J, Fairhurst RM, Diakite M, Malenga G, Molyneux M, Rwagacondo C, Obonyo C, Gadisa E, Aseffa A, Loolpapit M, Henry MC, Dorsey G, John C, Sirima SB, Barnes KI, Kremsner P, Day NP, White NJ, Mukaka M.

2018-01-1815 citations

10.1186/s12916-017-0990-6

Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials

Guido J. H. Bastiaens, Alfred B. Tiono, Joseph Okebe, Helmi Pett, Sam Coulibaly et al. (18 authors)

PLoS ONE2018-01-1143 citations

10.1371/journal.pone.0190272

The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial.

Okebe J, Bousema T, Affara M, DiTanna G, Eziefula AC, Jawara M, Nwakanma D, Amambua-Ngwa A, Van Geertruyden JP, Drakeley C, D'Alessandro U.

2015-03-0110 citations

10.1186/s13063-015-0597-1

Interventions

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

DRUGArtemether-Lumefantrine (AL) combination

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Haemoglobin concentration relative to baseline value	28 days	Haemoglobin concentration relative to baseline value

Secondary

Measure	Time frame	Description
Gametocyte clearance time	14 days	Gametocyte clearance time

Countries

Burkina Faso

Outcome results

None listed