Phase2a Primaquine Dose Escalation Study

Malaria Clinical Trial

Official title:

Phase 2a Dose Escalation Study of the Efficacy, Safety, and Pharmacokinetics of Low Dose Primaquine for Gametocytocidal Activity Against P. Falciparum in Sub-Saharan Africa and South East Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743820
• Other study ID #: MEG001
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2012
• Last updated: January 16, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMali: comités d'éthiqueThailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.

Other known NCT identifiers

• NCT02011555

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male

• Age >= 18 years and < 50 years

• Malaria blood thick film positive

• Presence of gametocytes on thick blood film

• Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits

• No allergies to study drugs

• Hemoglobin >= 8 g/dl

• No evidence of severe or chronic disease

• Written, informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• dihydroartemisinin-piperaquine

• 0.125 mg/kg Primaquine

• 0.5 mg/kg Primaquine

• 0.25 mg/kg Primaquine

• 0.0625 mg/kg Primaquine

Locations

Country	Name	City	State
Mali	Malaria Research and Training Centre	Bamako

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	Bill and Melinda Gates Foundation, Mahidol Oxford Tropical Medicine Research Unit, Malaria Research and Training Center, Bamako, Mali, Shoklo Malaria Research, Tak, Thailand, Wellcome Trust

Country where clinical trial is conducted

Mali, 

References & Publications (6)

Baird JK, Schwartz E, Hoffman SL. Prevention and treatment of vivax malaria. Curr Infect Dis Rep. 2007 Jan;9(1):39-46. — View Citation

El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. — View Citation

Gosling RD, Okell L, Mosha J, Chandramohan D. The role of antimalarial treatment in the elimination of malaria. Clin Microbiol Infect. 2011 Nov;17(11):1617-23. doi: 10.1111/j.1469-0691.2011.03660.x. Epub 2011 Sep 26. Review. — View Citation

Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, van den Bosch S, Koenderink JB, Luty AJ, Whitty CJ, Drakeley C, Sauerwein RW, Bousema T. In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals. Antimicrob Agents Chemother. 2010 May;54(5):1762-8. doi: 10.1128/AAC.01135-09. Epub 2010 Mar 1. — View Citation

WHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization

WHO (2011) World Malaria Report 2011. Geneva: World Health Organization.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mosquito infectivity assessed through membrane feeding	Baseline, Days 1, 2, 7	7 days	No
Secondary	gametocyte prevalence and density	Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28	28 days	No
Secondary	primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite	Hours 1, 2, 3, 4, 6, 8, 12, 24	24 hours	No
Secondary	asexual parasite prevalence and density	Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28	28 days	No
Secondary	safety measurements including hemoglobin and signs of hemolysis	Baseline, Days 1, 2, 3, 7, 14, 28	28 days	Yes