Clinical Trial: RT-PCR on Urine Samples: Added Value for the Diagnosis of Chikungunya Virus Infection
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: RT-PCR on Urine Samples: Added Value for the Diagnosis of Chikungunya Virus Infection
Brief Summary:
Retrospective laboratory evaluation of the detection rate of CHIKV infection by real-time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) on urine. Urine and serum samples from patients with confirmed CHIKV infections from an endemic area (Aruba) and from ITM will be analyzed. The results will be evaluated on a case-by-case basis: time since onset, patient characteristics, severity of symptoms, serology results.
The positivity in-time of CHIKV RNA in urine will be evaluated in comparison with viremia. Patients with suspected acute CHIKV infection will be asked (by written informed consent; annex 1) to provide urine samples within 72 hours after onset of disease, followed by urine samples on day 7, day 10, day 14 and three urine samples 3, 4 and 12 weeks after onset. They will be asked to provide serum samples within 72 hours after onset of disease, followed by serum samples on day 7, day 10, day 14. In total, twenty patients with an initial positive result of CHIKV RT-PCR on serum will be included for follow-up. The number of urine samples that will be tested is 140.
Detailed Summary:
Objectives
- To assess the added value of RT-PCR for CHIKV on urine samples for diagnosing CHIKV infection in comparison to the reference methods.
- To describe the kinetics of RT- PCR for CHIKV on urine samples for diagnosing CHIKV infection over time.
Study design, population, materials and methods:
Prospective cohort study of patients with a confirmed CHIKV infection (positive RT-PCR for CHIKV on the sample at the time of inclusion or seroconversion defined as positive anti-CHIKV Immunoglobulin M (IgM) antibody assay on day 14), who attend the outpatient clinic of the Institute of Tropical Medicine in Antwerp and the Horacio Oduber Hospitaal in Aruba within 72 hours after fever onset. After signing informed consent, clinical and epidemiological data will be recorded in a standardized Case Record Form. Baseline blood and urine samples will be collected as required for routine clinical evaluation of the individual case; sampling will include serum CHIKV serologic assays, CHIKV E1 (or similar rapid test), as well as serum and urine for RT-PCR for CHIKV. After the initial evaluation, suspected CHIKV cases are scheduled for biweekly serum and urine collection for RT-PCR for CHIKV for a duration of 2 weeks, then after 3, 4 and 12 weeks. Serum at 4 weeks will be used for second serologic assay. Suspected cases that test negative for CHIKV by RT-PCR on serum will be excluded.
Study population : patients with confirmed CHIKV infection Sample size : panel of 20 CHIKV confirmed cases Data analysis and reporting : The percentages of positive urine RT-PCR (over different time-points of duration of the CHIKV infection) will be calculated. Proportions of positivity ra
Sponsor: Institute of Tropical Medicine, Belgium
Current Primary Outcome: detection rate of chikungunya virus by RT-PCR in urine samples [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Institute of Tropical Medicine, Belgium
Dates:
Date Received: March 16, 2016
Date Started: March 2016
Date Completion: July 2017
Last Updated: January 20, 2017
Last Verified: January 2017
