CuraChik : A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease
|First Received Date ICMJE||October 20, 2006|
|Last Updated Date||October 8, 2008|
|Start Date ICMJE||May 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00391313 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||CuraChik : A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease|
|Official Title ICMJE||CuraChik : Double Blind Placebo-Controlled Randomized Trial : Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease.|
A severe outbreak of Chikungunya fever has been reported at La Réunion Island (France) in 2005-2006. Chikungunya is a viral disease. Chikungunya virus is an alphavirus transmitted to humans by the bite of infected mosquitoes, usually of the genus Aedes (Aedes albopictus in La Réunion).
To date, more than 266,000 cases were estimated to have occurred in the island (760,000 inhabitants). Most of cases are expressed as a mild disease, with intense fever and arthralgias, with rare but serious complications (encephalitis, liver, cardiac or renal failures.) having required a hospitalization in an intensive care unit. 273 of such serious cases (immediately life threatening condition) have been reported among the cases, in patients aged over 10 days (59% were 65+ age old). Chikungunya was proven in 246 serious cases; 101 patients had comorbidities, and 27% of confirmed cases eventually died. In addition 44 cases of mother-to-child infections were reported and 40 were confirmed (one died).
To date, in 248 death certificates, chikungunya was reported as the direct or indirect cause of death, with a median age of 79, range 0-102, and a sex-ratio (M/F) of 0.95. InVS, in collaboration with Inserm (French NIH) also reported (by June 6, 2006) a significant excess of mortality (from all causes) during the major outbreak which occurred from December, 2005 (+10%) to April, 2006 (10.1%), with a peak of excess mortality reached in February (+34.4%), concommitant to the peak of incidence.
Today, there is no antiviral treatment against Chikungunya. We showed from ex-vivo studies (in a sensitive model of cells culture to the viral infection) that chloroquine provides a significant inhibition on the replication of the Chikungunya virus. This efficacy seemed also to be reached at a plasmatic concentration of similar order of magnitude as recommended for treating malaria with this drug.
This trial aims to assess efficacy and safety of chloroquine as as therapeutic treatment of chikungunya disease.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Chikungunya Virus|
|Intervention ICMJE||Drug: Chloroquine|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Enrollment ICMJE||Not Provided|
|Completion Date||March 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 66 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||France|
|NCT Number ICMJE||NCT00391313|
|Other Study ID Numbers ICMJE||2006-002624-42|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Assistance Publique Hopitaux De Marseille|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Assistance Publique Hopitaux De Marseille|
|Verification Date||October 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP