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RT-PCR on Urine Samples: Added Value for the Diagnosis of Chikungunya Virus Infection (CHIK_urine)

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ClinicalTrials.gov Identifier: NCT02714985
Recruitment Status : Suspended
First Posted : March 22, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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.


Condition or disease
Chikungunya Fever

Detailed Description:

Objectives

  1. To assess the added value of RT-PCR for CHIKV on urine samples for diagnosing CHIKV infection in comparison to the reference methods.
  2. 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 rates will be tested by χ²-test for equality of proportions. Ct-values between two different sample types (serum/urine) will be compared by calculation of Spearman's rank correlation coefficient (ρ). The Ct-values measured will be subtracted (indicated by ∆Ct) and the mean of all ∆Ct-values (± 95% confidence interval) will be calculated. Reporting in accordance with Standards for Reporting of Diagnostic Accuracy (STARD) guidelines.

Endpoints: diagnostic sensitivity of CHIKV RT-PCR on urine samples in patients with a confirmed CHIKV infection, comparison of analytical sensitivity (based on Ct-values) with RT-PCR on serum, positivity rates of RT-PCR urine samples over time Ethical issues: Informed consent will be obtained from study participants. Demographic, geographic, clinical and laboratory data will be obtained; the data are de-identified and stored in an encoded database (code known to the principal investigators). Ethical approval through the ITM/ University Hospital Antwerp (UZA) Ethics Committee (EC) and the EC in Aruba.

Expected results and relevance :

Evaluation of the sensitivity of RT-PCR on urine samples for diagnosing CHIKV infection in the post-viremic phase in both endemic and non-endemic settings. Possible advantages of the use of PCR on urine over serological assays are:

  1. a shift in timeframe for accurately diagnosing CHIKV infection that could benefit returning travelers who consult after the acute phase.
  2. the use of single specimens that are obtained by non-invasive procedures
  3. high specificity
  4. the opportunity for typing of CHIKV strains.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: RT-PCR on Urine Samples: Added Value for the Diagnosis of Chikungunya Virus Infection
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort
confirmed chikungunya cases
cases with confirmed chikungunya fever and included for follow-up as per protocol



Primary Outcome Measures :
  1. detection rate of chikungunya virus by RT-PCR in urine samples [ Time Frame: 12 weeks ]
    in patients with a confirmed CHIKV infection, comparison of analytical sensitivity (based on Ct-values) with RT-PCR on serum, positivity rates of RT-PCR urine samples over time


Biospecimen Retention:   Samples Without DNA
serum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with a confirmed chikungunya virus (CHIKV) infection, who attend the outpatient clinic of the Institute of Tropical Medicine in Antwerp or the Horacio Oduber Hospitaal in Aruba within 72 hours after fever onset.
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • clinical suspicion of CHIKV infection, i.e.
  • fever (≥38°C) AND arthralgia OR rash
  • Confirmation of CHIKV infection by RT-PCR on serum or seroconversion (defined as positive anti-CHIKV IgM antibody assay on day 14)
  • living within 50 kilometer of either study site (ITM Antwerp, on Aruba)
  • Willing and able to provide written informed consent (assent for minors).

Exclusion Criteria:

  • Alternative diagnosis at the time of evaluation
  • Unable to produce urine sample by spontaneous micturition

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): NCT02714985


Locations
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Aruba
Horacio Oduber Hospitaal
Oranjestad, Aruba
Belgium
ITM
Antwerp, Belgium, 2000
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Investigators
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Study Chair: Emmanuel Bottieau, MD PhD Institute of Tropical Medicine, Antwerp, Belgium

Additional Information:

Publications:

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02714985     History of Changes
Other Study ID Numbers: B300201525794
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Institute of Tropical Medicine, Belgium:
chikungunya virus
RT-PCR
urine
diagnosis
Additional relevant MeSH terms:
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Chikungunya Fever
Virus Diseases
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections