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Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya (EchoCHIK)

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ClinicalTrials.gov Identifier: NCT02281123
Recruitment Status : Unknown
Verified July 2015 by University Hospital Center of Martinique.
Recruitment status was:  Active, not recruiting
First Posted : November 3, 2014
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

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.

Condition or disease Intervention/treatment
Infected by Chikungunya Virus Other: SF36 (QQoL)

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya
Study Start Date : July 2014
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Group/Cohort Intervention/treatment
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
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02281123


Locations
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Martinique
CHU de Martinique
Fort-de-France, Martinique, 97200
Sponsors and Collaborators
University Hospital Center of Martinique
Investigators
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Principal Investigator: Lauren Brunier-Agot, MD CHU de Martinique

Additional Information:
Publications:

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT02281123     History of Changes
Other Study ID Numbers: 14/B/03
2014-A00875-42 ( Other Identifier: ANSM )
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Chikungunya Fever
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases