Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya (EchoCHIK)
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| ClinicalTrials.gov Identifier: NCT02281123 |
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Recruitment Status : Unknown
Verified July 2015 by University Hospital Center of Martinique.
Recruitment status was: Active, not recruiting
First Posted : November 2, 2014
Last Update Posted : July 28, 2015
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Sponsor:
University Hospital Center of Martinique
Information provided by (Responsible Party):
University Hospital Center of Martinique
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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) |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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
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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 :
- 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 :
- 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:
- 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
- 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
Exclusion Criteria:
- 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
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
| Martinique | |
| CHU de Martinique | |
| Fort-de-France, Martinique, 97200 | |
Sponsors and Collaborators
University Hospital Center of Martinique
Investigators
| Principal Investigator: | Lauren Brunier-Agot, MD | CHU de Martinique |
Additional Information:
Publications:
Publications:
| Responsible Party: | University Hospital Center of Martinique |
| ClinicalTrials.gov Identifier: | NCT02281123 |
| Other Study ID Numbers: |
14/B/03 2014-A00875-42 ( Other Identifier: ANSM ) |
| First Posted: | November 2, 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 Arbovirus Infections Vector Borne Diseases |
Infections Virus Diseases Togaviridae Infections RNA Virus Infections |