Open Study on the Tolerability and Efficacy of the Combination Chlorproguanil-Dapsone+Artesunate Compared to Amodiaquine+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria in Rwandan Children
Sponsor study identifier
interventional
800
1 country
1
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2006
Actual (reported)In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up until day 28 after treatment. Adverse events, clinical and parasitological outcomes were recorded.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
October 2006
Actual (reported)April 16, 2007
Actual (reported)April 18, 2007
Actual (reported)Incidence of microscopically and genotypically confirmed recrudescent infections in the different treatment groups by day 28
Parasite clearance
Fever clearance
Occurrence of adverse events
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Chlorproguanil-dapsone + artesunate
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordProgramme Nationale Integre de Lutte contre le Paludisme
Kigali, BP 2514, Rwanda
Fanello CI, Karema C, Avellino P, Bancone G, Uwimana A, Lee SJ, d'Alessandro U, Modiano D. High risk of severe anaemia after chlorproguanil-dapsone+artesunate antimalarial treatment in patients with G6PD (A-) deficiency. PLoS One. 2008;3(12):e4031. doi: 10.1371/journal.pone.0004031. Epub 2008 Dec 29.
Fanello CI, Karema C, Ngamije D, Uwimana A, Ndahindwa V, Van Overmeir C, Van Doren W, Curtis J, D'Alessandro U. A randomised trial to assess the efficacy and safety of chlorproguanil/dapsone + artesunate for the treatment of uncomplicated Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2008 May;102(5):412-20. doi: 10.1016/j.trstmh.2008.01.013. Epub 2008 Mar 6.
Umberto d'Alessandro, MD
ITM
First Submitted
April 16, 2007
First Posted
April 18, 2007
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
October 2006
Actual (reported)A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria
Contact the study team to confirm eligibility.
Last Updated
April 18, 2007
Record last verified: 2007-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: