Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391313
Status:
TERMINATED
Last Update Posted:
2015-08-28
First Post:
2006-10-20
Brief Title:
CuraChik A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
CuraChik Double Blind Placebo-controlled Randomized Trial Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated Chikungunya diseases has regressed and no more patients was suffering
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 266000 cases were estimated to have occurred in the island 760000 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 MF of 095 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 101 with a peak of excess mortality reached in February 344 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
To date more than 266000 cases were estimated to have occurred in the island 760000 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 MF of 095 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 101 with a peak of excess mortality reached in February 344 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None