Chikungunya VirusPhase 3NCT00391313
CuraChik : A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease
A Phase 3 study testing Chloroquine in people with Chikungunya Virus, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Chikungunya Virus
- What is being tested?
- Chloroquine
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- May 2006to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant Women
- More than 66 years old
- body weight less than 60 kg
- without counter-indications to chloroquine
- Renal Insufficiency
- Retinopathy
- Coeliac disease
Trial locations and contacts
1 site in 1 country.
France1 site
Cellule Coordination Nivachik
Saint-Pierre, Ile de La Reunion, 97400
About this study
Official title: 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).
Read more
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.
- Conditions
- Chikungunya Virus
- Being tested
- Chloroquine
- Keywords
- Chikungunya, Chikungunya disease
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startMay 2006
- Study completionMar 2007
Why it stopped: Terminated Chikungunya diseases has regressed and no more patients was suffering
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya VirusStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Investigators
- Xavier de Lamballerie, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391313
- Sponsor's protocol ID
- 2006-002624-42
- Status last verified
- Aug 2015
- First submitted
- 20 Oct 2006
- Last updated
- 28 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CuraChik : Double Blind Placebo-controlled Randomized Trial : Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease.
- ClinicalTrials.gov ID
- NCT00391313
- Acronym / sponsor ID
- 2006-002624-42
- Conditions
- Chikungunya Virus
- Keywords
- Chikungunya, Chikungunya disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated Chikungunya diseases has regressed and no more patients was suffering
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnant Women
- More than 66 years old
- body weight less than 60 kg
- without counter-indications to chloroquine
- Renal Insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloroquine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Terminated Chikungunya diseases has regressed and no more patients was suffering). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
Related trials for Chikungunya Virus
Active, not recruitingPhase 3
A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
Chikungunya Virus
Not yet recruitingPhase 2
Evaluation of IXCHIQ® Vaccine Immunogenicity
Healthy Adult, Healthy Adolescents
RecruitingPhase 4
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
Chikungunya Virus Infection
Recruiting
Against Chikungunya Virus and Neonatal Infection
Chikungunya Virus Infection, Neonatal
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier de Lamballerie, MD principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chloroquine in people with Chikungunya Virus, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated Chikungunya diseases has regressed and no more patients was suffering). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2015.