Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria
NCT ID: NCT00484900
Last Updated: 2008-03-26
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
PHASE3
1390 participants
INTERVENTIONAL
2006-05-31
2007-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Co-Arinate FDC
Coartem
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* weight at least 5 kg,
* residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
* able to receive oral treatment,
* having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
* suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.
Exclusion Criteria
* severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
* allergic to one of the drugs involved in this study,
* pregnant (reported pregnancy, detected clinically or with the β HCG test),
* use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.
6 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dafra Pharma
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Issaka Sagara, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Bamako, Mali
Wilfred F Mbacham, Dr
Role: PRINCIPAL_INVESTIGATOR
University Yaoundé, Cameroon
Ishag A Adam, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Khartoum, Sudan
Stephen Rulisa, Dr
Role: PRINCIPAL_INVESTIGATOR
Kigali Central University Hospital, Rwanda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cameroon Baptist Convention Clinic of Biyem-Assi
Yaoundé, , Cameroon
Health centres of Samako, Kolle and Bancoumane
Bamako, , Mali
Health centres Rwamagana and Muhima
Kigali, , Rwanda
Alhara Alola Health centre
New Halfa, , Sudan
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.
Sagara I, Rulisa S, Mbacham W, Adam I, Sissoko K, Maiga H, Traore OB, Dara N, Dicko YT, Dicko A, Djimde A, Jansen FH, Doumbo OK. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar J. 2009 Apr 14;8:63. doi: 10.1186/1475-2875-8-63.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005/57/01
Identifier Type: -
Identifier Source: org_study_id