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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 2

Locations

Burkina Faso

Study Type

Interventional

Intervention

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

Artemether-Lumefantrine (AL) combination

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

About this trial

This is an interventional treatment trial for Malaria focused on measuring G6PD deficiency, safety, transmission

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Centre National de Recherche et de Formation sur le Paludisme

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

G6PD deficient 0.25 mg/kg PQ + AL

G6PD deficient receiving AL only

G6PD normal 0.25 mg/kg PQ + AL

G6PD normal 0.4 mg/kg PQ + AL

G6PD-deficient 0.4 mg/kg PQ + AL

Arm Description

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

G6PD deficient males receiving Artemether-Lumefantrine (AL) combination

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

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

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

Outcomes

Primary Outcome Measures

Haemoglobin concentration relative to baseline value

Secondary Outcome Measures

Gametocyte clearance time

Full Information

NCT ID

NCT02174900

First Posted

June 11, 2014

Last Updated

January 29, 2016

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02174900

Brief Title

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

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

G6PD deficiency, safety, transmission

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G6PD deficient 0.25 mg/kg PQ + AL

Arm Type

Experimental

Arm Description

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

Arm Title

G6PD deficient receiving AL only

Arm Type

Active Comparator

Arm Description

G6PD deficient males receiving Artemether-Lumefantrine (AL) combination

Arm Title

G6PD normal 0.25 mg/kg PQ + AL

Arm Type

Active Comparator

Arm Description

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

Arm Title

G6PD normal 0.4 mg/kg PQ + AL

Arm Type

Active Comparator

Arm Description

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

Arm Title

G6PD-deficient 0.4 mg/kg PQ + AL

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

Artemether-Lumefantrine (AL) combination

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Haemoglobin concentration relative to baseline value

Description

Haemoglobin concentration relative to baseline value

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Gametocyte clearance time

Description

Gametocyte clearance time

Time Frame

14 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teun Bousema, PhD

Organizational Affiliation

LSHTM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre National de Recherche et de Formation sur le Paludisme

City

Ouagadougou

Country

Burkina Faso

12. IPD Sharing Statement

Citations:

PubMed Identifier

29324864

Citation

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.

Results Reference

derived

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

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