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

NCT02174900 | Completed Phase 2 DMC

• 1 other identifier: SAFEPRIM
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

G6PD deficiency; safety; transmission

Outcome Measures

Primary Outcomes (1)

• Haemoglobin concentration relative to baseline value

  Haemoglobin concentration relative to baseline value

  28 days

Secondary Outcomes (1)

• Gametocyte clearance time

  14 days

Study Arms (5)

G6PD deficient 0.25 mg/kg PQ + AL

EXPERIMENTAL

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

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

G6PD deficient receiving AL only

ACTIVE COMPARATOR

G6PD deficient males receiving Artemether-Lumefantrine (AL) combination

Drug: Artemether-Lumefantrine (AL) combination

G6PD normal 0.25 mg/kg PQ + AL

ACTIVE COMPARATOR

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

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

G6PD normal 0.4 mg/kg PQ + AL

ACTIVE COMPARATOR

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

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

G6PD-deficient 0.4 mg/kg PQ + AL

EXPERIMENTAL

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

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

Interventions

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

G6PD deficient 0.25 mg/kg PQ + AL; G6PD normal 0.25 mg/kg PQ + AL

Artemether-Lumefantrine (AL) combination DRUG

G6PD deficient receiving AL only

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

G6PD normal 0.4 mg/kg PQ + AL; G6PD-deficient 0.4 mg/kg PQ + AL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Centre national de recherche et de formation sur le paludisme: collaborator
• University Medical Center Nijmegen: collaborator

Study Sites (1)

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, Burkina Faso

Location

Related Publications (1)

• Bastiaens GJH, Tiono AB, Okebe J, Pett HE, Coulibaly SA, Goncalves BP, Affara M, Ouedraogo A, Bougouma EC, Sanou GS, Nebie I, Bradley J, Lanke KHW, Niemi M, Sirima SB, d'Alessandro U, Bousema T, Drakeley C. Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials. PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272. eCollection 2018.

  PMID: 29324864 DERIVED

MeSH Terms

Conditions

Malaria; Glucosephosphate Dehydrogenase Deficiency

Interventions

Artemether, Lumefantrine Drug Combination; Primaquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Teun Bousema, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 26, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

BU (1)