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

Malaria Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174900
• Other study ID #: SAFEPRIM
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 11, 2014
• Last updated: January 29, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of HealthUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

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

• Artemether-Lumefantrine (AL) combination

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

Locations

Country	Name	City	State
Burkina Faso	Centre National de Recherche et de Formation sur le Paludisme	Ouagadougou

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso, University Medical Center Nijmegen

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin concentration relative to baseline value	Haemoglobin concentration relative to baseline value	28 days	Yes
Secondary	Gametocyte clearance time	Gametocyte clearance time	14 days	No