Infected by Chikungunya VirusEchoCHIKNCT02281123

Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya

An observational study of Infected by Chikungunya Virus, run by University Hospital Center of Martinique at 1 site in Martinique.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Infected by Chikungunya Virus
What is being tested?: SF36 (QQoL)
How many people: 200 participants
Where: 1 siteMartinique
Study dates: Jul 2014to Jan 2016
Phase: Observational
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Recruitment will be done among the patients from the Fort-de-France hospital and came for a suspected infection by the chikungunya virus

Who may be able to join

Age at onset of symptoms ≥ 45 years
Seen in consultation at the University Hospital of Fort-de-France
Suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees)
Duration of symptoms suggestive of infection chikungunya less than or equal to 10 days
Presence of joint pain on the day of inclusion
No history of inflammatory arthritis

Show all 10Show fewer

Absence of steroidal or non-steroidal anti-inflammatory drugs taken within two weeks prior to inclusion
Ability to participate in the study throughout its duration (12 months)
Patient affiliated or beneficiary of a social health care.
Acceptance to participate in the study and monitoring proposed and signed informed consent

Who cannot join

Age at onset of symptoms <45 years
Duration of symptoms suggestive of chikungunya for more than 10 days
Lack of joint pain on the day of inclusion
History of inflammatory arthritis Nonsteroidal anti-inflammatory drugs or
Taking in the two weeks preceding the inclusion
Inability to participate in the study throughout its duration (12 months)
Patient is not affiliated or beneficiary of a social health care.
Refusal to participate in the study or to sign a consent

Trial locations and contacts

1 site in 1 country.

Martinique1 site

CHU de Martinique
Fort-de-France, 97200

Other trials in Martinique

About this study

Chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early joint damage. Approximately 8% of patients have chronic arthropathy resembling to the rheumatoid polyarthritis. The EchoCHIK study we propose is in the context of the epidemic in Martinique which began in January 2014. It should give a better understanding of arthritis and juxtaarticular of CHIK and look for signs that may allow ultrasound predict the evolution of chronic arthropathy of CHIK.

Conditions: Infected by Chikungunya Virus
Being tested: SF36 (QQoL)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SF36 (QQoL)Other
use of quality of life questionnaire (SF 36) ( at enrollment visit, at 3 month, at 6 month and at12 month for the following visits)

Study groups in NCT02281123
Study group	Role	What they receive
Patient suspected of being infected by chikungunya		Patient (>= 45 ans) suspect d'infection par le virus du chikungunya et présentant des symptomes depuis moins de 10 jours Receives: Other: SF36 (QQoL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Presence of sonographic signs observed during the initial scan: periarticular infiltration, effusion, positive Doppler, erosions.
Progression to chronic form defined by the persistence or recurrence of muscle symptoms (myalgia) and joints (arthralgia, arthritis) more than two months after the onset of symptoms of acute phase.
Measured: enrollement visit

Secondary outcomes (1)

Presence of clinical and sonographic signs observed at each visit: arthralgia, arthritis clinics, periarticular infiltration, effusion, positive Doppler erosions.
Measured: 1 month, 3 month, 6 month and 12 month after the first symptoms of infection by chikungunya virus

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Jan 2016

First posted3 Nov 2014 (estimated)
Study startJul 2014
Primary completionJan 2015
Study completionJan 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Infected by Chikungunya VirusStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02281123
Sponsor's protocol ID: 14/B/03
Other IDs: 2014-A00875-42
Acronym: EchoCHIK
Status last verified: Jul 2015
First submitted: 29 Oct 2014
Last updated: 28 Jul 2015
Results posted: No
Data monitoring committee: No

Publications

Pialoux G, Gauzere BA, Jaureguiberry S, Strobel M. Chikungunya, an epidemic arbovirosis. Lancet Infect Dis. 2007 May;7(5):319-27. doi: 10.1016/S1473-3099(07)70107-X.
PubMed 17448935
Fourie ED, Morrison JG. Rheumatoid arthritic syndrome after chikungunya fever. S Afr Med J. 1979 Jul 28;56(4):130-2.
PubMed 494034
Kennedy AC, Fleming J, Solomon L. Chikungunya viral arthropathy: a clinical description. J Rheumatol. 1980 Mar-Apr;7(2):231-6.
PubMed 7373626
Brighton SW, Prozesky OW, de la Harpe AL. Chikungunya virus infection. A retrospective study of 107 cases. S Afr Med J. 1983 Feb 26;63(9):313-5.
PubMed 6298956
Simon F, Parola P, Grandadam M, Fourcade S, Oliver M, Brouqui P, Hance P, Kraemer P, Mohamed AA, de Lamballerie X, Charrel R, Tolou H. Chikungunya infection: an emerging rheumatism among travelers returned from Indian Ocean islands. Report of 47 cases. Medicine (Baltimore). 2007 May;86(3):123-137. doi: 10.1097/MD/0b013e31806010a5.
PubMed 17505252
Taubitz W, Cramer JP, Kapaun A, Pfeffer M, Drosten C, Dobler G, Burchard GD, Loscher T. Chikungunya fever in travelers: clinical presentation and course. Clin Infect Dis. 2007 Jul 1;45(1):e1-4. doi: 10.1086/518701. Epub 2007 May 23.
PubMed 17554689
Bouquillard E, Combe B. A report of 21 cases of rheumatoid arthritis following Chikungunya fever. A mean follow-up of two years. Joint Bone Spine. 2009 Dec;76(6):654-7. doi: 10.1016/j.jbspin.2009.08.005.
PubMed 19945329
Larrieu S, Pouderoux N, Pistone T, Filleul L, Receveur MC, Sissoko D, Ezzedine K, Malvy D. Factors associated with persistence of arthralgia among Chikungunya virus-infected travellers: report of 42 French cases. J Clin Virol. 2010 Jan;47(1):85-8. doi: 10.1016/j.jcv.2009.11.014. Epub 2009 Dec 8.
PubMed 20004145
Ribera A, Degasne I, Jaffar Bandjee MC, Gasque P. [Chronic rheumatic manifestations following chikungunya virus infection: clinical description and therapeutic considerations]. Med Trop (Mars). 2012 Mar;72 Spec No:83-5. French.
PubMed 22693935
Manimunda SP, Vijayachari P, Uppoor R, Sugunan AP, Singh SS, Rai SK, Sudeep AB, Muruganandam N, Chaitanya IK, Guruprasad DR. Clinical progression of chikungunya fever during acute and chronic arthritic stages and the changes in joint morphology as revealed by imaging. Trans R Soc Trop Med Hyg. 2010 Jun;104(6):392-9. doi: 10.1016/j.trstmh.2010.01.011. Epub 2010 Feb 19.
PubMed 20171708
Gerardin P, Fianu A, Michault A, Mussard C, Boussaid K, Rollot O, Grivard P, Kassab S, Bouquillard E, Borgherini G, Gauzere BA, Malvy D, Breart G, Favier F. Predictors of Chikungunya rheumatism: a prognostic survey ancillary to the TELECHIK cohort study. Arthritis Res Ther. 2013 Jan 9;15(1):R9. doi: 10.1186/ar4137.
PubMed 23302155

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya
ClinicalTrials.gov ID: NCT02281123
Acronym / sponsor ID: EchoCHIK / 14/B/03
Conditions: Infected by Chikungunya Virus
Study type: Observational
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: University Hospital Center of MartiniqueUniversity, hospital or other
Study start: Jul 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2016 (estimated)
First posted: 3 Nov 2014 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patient suspected of being infected by chikungunya	–	Other: SF36 (QQoL)Patient (>= 45 ans) suspect d'infection par le virus du chikungunya et présentant des symptomes depuis moins de 10 jours

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Recruitment will be done among the patients from the Fort-de-France hospital and came for a suspected infection by the chikungunya virus

Key inclusion criteria (10 listed)

Age at onset of symptoms ≥ 45 years
Seen in consultation at the University Hospital of Fort-de-France
Suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees)
Duration of symptoms suggestive of infection chikungunya less than or equal to 10 days
Presence of joint pain on the day of inclusion

Key exclusion criteria (8 listed)

Age at onset of symptoms <45 years
Duration of symptoms suggestive of chikungunya for more than 10 days
Lack of joint pain on the day of inclusion
History of inflammatory arthritis Nonsteroidal anti-inflammatory drugs or
Taking in the two weeks preceding the inclusion

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
SF36 (QQoL)use of quality of life questionnaire (SF 36) ( at enrollment visit, at 3 month, at 6 month and at12 month for the following visits)	Other	Patient suspected of being infected by chikungunya

Primary outcome

Presence of sonographic signs observed during the initial scan: periarticular infiltration, effusion, positive Doppler, erosions.
Time frame: enrollement visit
Progression to chronic form defined by the persistence or recurrence of muscle symptoms (myalgia) and joints (arthralgia, arthritis) more than two months after the onset of symptoms of acute phase.

1 secondary outcome

Presence of clinical and sonographic signs observed at each visit: arthralgia, arthritis clinics, periarticular infiltration, effusion, positive Doppler erosions.
Time frame: 1 month, 3 month, 6 month and 12 month after the first symptoms of infection by chikungunya virus

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Background: PubMed 17448935Pialoux G, Gauzere BA, Jaureguiberry S, Strobel M. Chikungunya, an epidemic arbovirosis. Lancet Infect Dis. 2007 May;7(5):319-27. doi: 10.1016/S1473-3099(07)70107-X.
Background: PubMed 494034Fourie ED, Morrison JG. Rheumatoid arthritic syndrome after chikungunya fever. S Afr Med J. 1979 Jul 28;56(4):130-2.
Background: PubMed 7373626Kennedy AC, Fleming J, Solomon L. Chikungunya viral arthropathy: a clinical description. J Rheumatol. 1980 Mar-Apr;7(2):231-6.
Background: PubMed 6298956Brighton SW, Prozesky OW, de la Harpe AL. Chikungunya virus infection. A retrospective study of 107 cases. S Afr Med J. 1983 Feb 26;63(9):313-5.
Background: PubMed 17505252Simon F, Parola P, Grandadam M, Fourcade S, Oliver M, Brouqui P, Hance P, Kraemer P, Mohamed AA, de Lamballerie X, Charrel R, Tolou H. Chikungunya infection: an emerging rheumatism among travelers returned from Indian Ocean islands. Report of 47 cases. Medicine (Baltimore). 2007 May;86(3):123-137. doi: 10.1097/MD/0b013e31806010a5.
Background: PubMed 17554689Taubitz W, Cramer JP, Kapaun A, Pfeffer M, Drosten C, Dobler G, Burchard GD, Loscher T. Chikungunya fever in travelers: clinical presentation and course. Clin Infect Dis. 2007 Jul 1;45(1):e1-4. doi: 10.1086/518701. Epub 2007 May 23.
Background: PubMed 19945329Bouquillard E, Combe B. A report of 21 cases of rheumatoid arthritis following Chikungunya fever. A mean follow-up of two years. Joint Bone Spine. 2009 Dec;76(6):654-7. doi: 10.1016/j.jbspin.2009.08.005.
Background: PubMed 20004145Larrieu S, Pouderoux N, Pistone T, Filleul L, Receveur MC, Sissoko D, Ezzedine K, Malvy D. Factors associated with persistence of arthralgia among Chikungunya virus-infected travellers: report of 42 French cases. J Clin Virol. 2010 Jan;47(1):85-8. doi: 10.1016/j.jcv.2009.11.014. Epub 2009 Dec 8.
Background: PubMed 22693935Ribera A, Degasne I, Jaffar Bandjee MC, Gasque P. [Chronic rheumatic manifestations following chikungunya virus infection: clinical description and therapeutic considerations]. Med Trop (Mars). 2012 Mar;72 Spec No:83-5. French.
Background: PubMed 20171708Manimunda SP, Vijayachari P, Uppoor R, Sugunan AP, Singh SS, Rai SK, Sudeep AB, Muruganandam N, Chaitanya IK, Guruprasad DR. Clinical progression of chikungunya fever during acute and chronic arthritic stages and the changes in joint morphology as revealed by imaging. Trans R Soc Trop Med Hyg. 2010 Jun;104(6):392-9. doi: 10.1016/j.trstmh.2010.01.011. Epub 2010 Feb 19.
Background: PubMed 23302155Gerardin P, Fianu A, Michault A, Mussard C, Boussaid K, Rollot O, Grivard P, Kassab S, Bouquillard E, Borgherini G, Gauzere BA, Malvy D, Breart G, Favier F. Predictors of Chikungunya rheumatism: a prognostic survey ancillary to the TELECHIK cohort study. Arthritis Res Ther. 2013 Jan 9;15(1):R9. doi: 10.1186/ar4137.
A destructive arthropathy following Chikungunya virus arthritis--a possible associationLink provided by the sponsor.
Destructive arthritis in a patient with chikungunya virus infection with persistent specific IgM antibodiesLink provided by the sponsor.
Post-Epidemic Chikungunya Disease on Reunion Island: Course of Rheumatic Manifestations and Associated Factors over a 15-Month PeriodLink provided by the sponsor.

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.

Lauren Brunier-Agot, MD principal investigator

CHU de Martinique

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Infected by Chikungunya Virus, run by University Hospital Center of Martinique at 1 site in Martinique.

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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Jul 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 Martinique. 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.

Are results available for this study?

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.

What does the primary outcome measure?

Presence of sonographic signs observed during the initial scan: periarticular infiltration, effusion, positive Doppler, erosions. (time frame: enrollement visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02281123, which also lists 11 linked publications.

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 Jul 2015.