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

January 29, 2016 updated by: London School of Hygiene and Tropical Medicine

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Centre National de Recherche et de Formation sur le Paludisme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G6PD deficient 0.25 mg/kg PQ + AL
G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
Active Comparator: G6PD deficient receiving AL only
G6PD deficient males receiving Artemether-Lumefantrine (AL) combination
Drug: Artemether-Lumefantrine (AL) combination
Active Comparator: G6PD normal 0.25 mg/kg PQ + AL
G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
Drug: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
Active Comparator: G6PD normal 0.4 mg/kg PQ + AL
G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
Experimental: G6PD-deficient 0.4 mg/kg PQ + AL
G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
Drug: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemoglobin concentration relative to baseline value
Time Frame: 28 days
Haemoglobin concentration relative to baseline value
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gametocyte clearance time
Time Frame: 14 days
Gametocyte clearance time
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

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

Investigators

  • Principal Investigator: Teun Bousema, PhD, LSHTM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAFEPRIM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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