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Sponsored by: |
Assistance Publique Hopitaux De Marseille |
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Information provided by: | Assistance Publique Hopitaux De Marseille |
ClinicalTrials.gov Identifier: | NCT00391313 |
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.
Condition | Intervention | Phase |
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Chikungunya Virus |
Drug: Chloroquine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | CuraChik : Double Blind Placebo-Controlled Randomized Trial : Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease. |
Ages Eligible for Study: | 18 Years to 66 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France, ile de la Reunion | |
Cellule Coordination Nivachik | |
Saint Pierre, ile de la Reunion, France, 97400 |
Principal Investigator: | Xavier de Lamballerie, MD | Assistance Publique Hopitaux De Marseille |
Study ID Numbers: | 2006-002624-42 |
Study First Received: | October 20, 2006 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00391313 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Chikungunya Chikungunya disease |
Anti-Inflammatory Agents Chikungunya Chloroquine Anthelmintics Togaviridae Infections Virus Diseases Antimalarials |
Analgesics, Non-Narcotic Chloroquine diphosphate Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Filaricides Physiological Effects of Drugs Chloroquine Anthelmintics Togaviridae Infections Pharmacologic Actions Virus Diseases Antimalarials |
Antiparasitic Agents Sensory System Agents Analgesics, Non-Narcotic Chloroquine diphosphate Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Amebicides Antirheumatic Agents Central Nervous System Agents Antinematodal Agents |