Working… Menu
Trial record 1 of 1 for:    "Chikungunya" | "Antiprotozoal Agents"
Previous Study | Return to List | Next Study

CuraChik : A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391313
Recruitment Status : Terminated (Terminated Chikungunya diseases has regressed and no more patients was suffering)
First Posted : October 23, 2006
Last Update Posted : August 28, 2015
Information provided by:
Assistance Publique Hopitaux De Marseille

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 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 or disease Intervention/treatment Phase
Chikungunya Virus Drug: Chloroquine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: CuraChik : Double Blind Placebo-controlled Randomized Trial : Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease.
Study Start Date : May 2006
Actual Study Completion Date : March 2007

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00391313

Layout table for location information
Cellule Coordination Nivachik
Saint Pierre, ile de la Reunion, France, 97400
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Layout table for investigator information
Principal Investigator: Xavier de Lamballerie, MD Assistance Publique Hopitaux De Marseille

Layout table for additonal information Identifier: NCT00391313     History of Changes
Other Study ID Numbers: 2006-002624-42
First Posted: October 23, 2006    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Assistance Publique Hopitaux De Marseille:
Chikungunya disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Chikungunya Fever
Antiprotozoal Agents
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Chloroquine diphosphate
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents