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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02281123
Other study ID # 14/B/03
Secondary ID 2014-A00875-42
Status Active, not recruiting
Phase N/A
First received October 29, 2014
Last updated July 27, 2015
Start date July 2014
Est. completion date January 2016

Study information

Verified date July 2015
Source Centre Hospitalier Universitaire de Fort-de-France
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date January 2016
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

1. Age at onset of symptoms = 45 years

2. Seen in consultation at the University Hospital of Fort-de-France

3. Suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees)

4. Duration of symptoms suggestive of infection chikungunya less than or equal to 10 days

5. Presence of joint pain on the day of inclusion

6. No history of inflammatory arthritis

7. Absence of steroidal or non-steroidal anti-inflammatory drugs taken within two weeks prior to inclusion

8. Ability to participate in the study throughout its duration (12 months)

9. Patient affiliated or beneficiary of a social health care.

10. Acceptance to participate in the study and monitoring proposed and signed informed consent

Exclusion Criteria:

1. Age at onset of symptoms <45 years

2. Duration of symptoms suggestive of chikungunya for more than 10 days

3. Lack of joint pain on the day of inclusion

4. History of inflammatory arthritis Nonsteroidal anti-inflammatory drugs or

5. Taking in the two weeks preceding the inclusion

6. Inability to participate in the study throughout its duration (12 months)

7. Patient is not affiliated or beneficiary of a social health care.

8. Refusal to participate in the study or to sign a consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
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)

Locations

Country Name City State
Martinique CHU de Martinique Fort-de-France

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Fort-de-France

Country where clinical trial is conducted

Martinique, 

References & Publications (11)

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. Epub . — View Citation

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. — View Citation

Fourie ED, Morrison JG. Rheumatoid arthritic syndrome after chikungunya fever. S Afr Med J. 1979 Jul 28;56(4):130-2. — View Citation

Gérardin P, Fianu A, Michault A, Mussard C, Boussaïd K, Rollot O, Grivard P, Kassab S, Bouquillard E, Borgherini G, Gaüzère BA, Malvy D, Bréart 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. — View Citation

Kennedy AC, Fleming J, Solomon L. Chikungunya viral arthropathy: a clinical description. J Rheumatol. 1980 Mar-Apr;7(2):231-6. — View Citation

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. — View Citation

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. — View Citation

Pialoux G, Gaüzère BA, Jauréguiberry S, Strobel M. Chikungunya, an epidemic arbovirosis. Lancet Infect Dis. 2007 May;7(5):319-27. Review. — View Citation

Ribéra 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. — View Citation

Simon F, Parola P, Grandadam M, Fourcade S, Oliver M, Brouqui P, Hance P, Kraemer P, Ali Mohamed A, 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):123-37. — View Citation

Taubitz W, Cramer JP, Kapaun A, Pfeffer M, Drosten C, Dobler G, Burchard GD, Löscher T. Chikungunya fever in travelers: clinical presentation and course. Clin Infect Dis. 2007 Jul 1;45(1):e1-4. Epub 2007 May 23. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. enrollement visit No
Secondary Presence of clinical and sonographic signs observed at each visit: arthralgia, arthritis clinics, periarticular infiltration, effusion, positive Doppler erosions. 1 month, 3 month, 6 month and 12 month after the first symptoms of infection by chikungunya virus No