Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2013-09-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of a Single Low-dose Primaquine for the Clearance of Gametocytes
NCT02090036
Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia
NCT02654730
Primaquine's Gametocytocidal Efficacy in Malaria Asymptomatic Carriers
NCT01838902
Low Dose Primaquine for Clearance of Gametocytes
NCT01935882
Phase 2 Efficacy Study of Primaquine and Methylene Blue
NCT02831023
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
dihydroartemisinin-piperaquine only
dihydroartemisinin -piperaquine (DP) only
dihydroartemisinin-piperaquine
DP and 0.125 mg/kg primaquine
DP and single dose oral 0.125 mg/kg primaquine
dihydroartemisinin-piperaquine
0.125 mg/kg Primaquine
DP and 0.5 mg/kg primaquine
DP and single dose oral 0.5 mg/kg primaquine
dihydroartemisinin-piperaquine
0.5 mg/kg Primaquine
DP and 0.25 mg/kg primaquine
DP and a single dose oral 0.25 mg/kg primaquine
dihydroartemisinin-piperaquine
0.25 mg/kg Primaquine
DP and 0.0625 mg/kg primaquine
DP and a single dose oral 0.0625 mg/kg primaquine
dihydroartemisinin-piperaquine
0.0625 mg/kg Primaquine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dihydroartemisinin-piperaquine
0.125 mg/kg Primaquine
0.5 mg/kg Primaquine
0.25 mg/kg Primaquine
0.0625 mg/kg Primaquine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
50 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Malaria Research and Training Center, Bamako, Mali
OTHER
Shoklo Malaria Research Unit
OTHER
Mahidol Oxford Tropical Medicine Research Unit
OTHER
Bill and Melinda Gates Foundation
OTHER
Wellcome Trust
OTHER
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roland Gosling, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Alassane Dicko, MD
Role: PRINCIPAL_INVESTIGATOR
Malaria Research and Training Centre
François Nosten, MD
Role: PRINCIPAL_INVESTIGATOR
Shoklo Malaria Research Unit
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Malaria Research and Training Centre
Bamako, , Mali
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Baird JK, Schwartz E, Hoffman SL. Prevention and treatment of vivax malaria. Curr Infect Dis Rep. 2007 Jan;9(1):39-46. doi: 10.1007/s11908-007-0021-4.
WHO (2011) World Malaria Report 2011. Geneva: World Health Organization.
WHO (2010) Guidelines for the treatment of malaria, Second edition. Geneva: World Health Organization
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. doi: 10.1371/journal.pone.0001311.
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.
Dicko A, Brown JM, Diawara H, Baber I, Mahamar A, Soumare HM, Sanogo K, Koita F, Keita S, Traore SF, Chen I, Poirot E, Hwang J, McCulloch C, Lanke K, Pett H, Niemi M, Nosten F, Bousema T, Gosling R. Primaquine to reduce transmission of Plasmodium falciparum malaria in Mali: a single-blind, dose-ranging, adaptive randomised phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):674-684. doi: 10.1016/S1473-3099(15)00479-X. Epub 2016 Feb 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MEG001
Identifier Type: -
Identifier Source: org_study_id
NCT02011555
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.