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

July 27, 2015 updated by: University Hospital Center of Martinique
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Martinique
      • Fort-de-France, Martinique, 97200
        • CHU de Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
enrollement visit

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 month, 3 month, 6 month and 12 month after the first symptoms of infection by chikungunya virus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Center of Martinique

Investigators

  • Principal Investigator: Lauren Brunier-Agot, MD, CHU de Martinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 30, 2014

First Posted (Estimate)

November 2, 2014

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/B/03
  • 2014-A00875-42 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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