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Completed

NCT Number: NCT02174900

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

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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Key information

Conditions

Malaria Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glucosephosphate Dehydrogenase Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Infections Metabolic Diseases Metabolism, Inborn Errors Mosquito-Borne Diseases Nutritional and Metabolic Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, Burkina Faso

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Artemether-Lumefantrine (AL) combination

Drug

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

Drug

Primary outcomes

  1. Haemoglobin concentration relative to baseline value

    Time frame: 28 days

    Haemoglobin concentration relative to baseline value

Secondary outcomes

  1. Gametocyte clearance time

    Time frame: 14 days

    Gametocyte clearance time

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Centre national de recherche et de formation sur le paludisme
  • University Medical Center Nijmegen

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2014
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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