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CuraChik : A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease
This study has been terminated.
( Terminated Chikungunya diseases has regressed and no more patients was suffering )
First Received: October 20, 2006   Last Updated: October 8, 2008   History of Changes
Sponsored by: Assistance Publique Hopitaux De Marseille
Information provided by: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00391313
  Purpose

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
Chikungunya Virus
Drug: Chloroquine
Phase III

Drug Information available for: Chloroquine diphosphate Chloroquine Chloroquine hydrochloride
U.S. FDA Resources
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.

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Study Start Date: May 2006
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients of more than 18 years and less than 66 years (men and nonpregnant women, without counter-indications) voluntary to take part in of the study, residing at the Reunion Island, having a body weight equal to or higher than 60 kg for a clinical chikungunya disease diagnosed within less than 48 hours.

Exclusion Criteria:

  • Pregnant Women
  • More than 66 years old
  • body weight less than 60 kg
  • without counter-indications to chloroquine
  • Renal Insufficiency
  • Retinopathy
  • Coeliac disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391313

Locations
France, ile de la Reunion
Cellule Coordination Nivachik
Saint Pierre, ile de la Reunion, France, 97400
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Xavier de Lamballerie, MD Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

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

Keywords provided by Assistance Publique Hopitaux De Marseille:
Chikungunya
Chikungunya disease

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009