Clinical trial NCT02281123: Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya
Official title: Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infected by Chikungunya Virus
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Presence of sonographic signs observed during the initial scan: periarticular infiltration, effusion, positive Doppler, erosions.
timeFrame: enrollement visit
Secondary outcomes:
measure: Presence of clinical and sonographic signs observed at each visit: arthralgia, arthritis clinics, periarticular infiltration, effusion, positive Doppler erosions.
timeFrame: 1 month, 3 month, 6 month and 12 month after the first symptoms of infection by chikungunya virus
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: CHU de Martinique
name: Lauren Brunier-Agot, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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