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

NCT02714985 | Withdrawn DMC

• 1 other identifier: B300201525794
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chikungunya Fever

Keywords

chikungunya virus; RT-PCR; urine; diagnosis

Outcome Measures

Primary Outcomes (1)

• detection rate of chikungunya virus by RT-PCR in 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

  12 weeks

Study Arms (1)

confirmed chikungunya cases

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (2)

Horacio Oduber Hospitaal

Oranjestad, Aruba

Location

ITM

Antwerp, 2000, Belgium

Location

Related Publications (10)

• Barzon L, Pacenti M, Franchin E, Pagni S, Martello T, Cattai M, Cusinato R, Palu G. Excretion of West Nile virus in urine during acute infection. J Infect Dis. 2013 Oct 1;208(7):1086-92. doi: 10.1093/infdis/jit290. Epub 2013 Jul 2.

  PMID: 23821721 BACKGROUND

• Blacksell SD, Tanganuchitcharnchai A, Jarman RG, Gibbons RV, Paris DH, Bailey MS, Day NP, Premaratna R, Lalloo DG, de Silva HJ. Poor diagnostic accuracy of commercial antibody-based assays for the diagnosis of acute Chikungunya infection. Clin Vaccine Immunol. 2011 Oct;18(10):1773-5. doi: 10.1128/CVI.05288-11. Epub 2011 Aug 24.

  PMID: 21865416 BACKGROUND

• Couturier E, Guillemin F, Mura M, Leon L, Virion JM, Letort MJ, De Valk H, Simon F, Vaillant V. Impaired quality of life after chikungunya virus infection: a 2-year follow-up study. Rheumatology (Oxford). 2012 Jul;51(7):1315-22. doi: 10.1093/rheumatology/kes015. Epub 2012 Mar 16.

  PMID: 22427407 BACKGROUND

• Gourinat AC, O'Connor O, Calvez E, Goarant C, Dupont-Rouzeyrol M. Detection of Zika virus in urine. Emerg Infect Dis. 2015 Jan;21(1):84-6. doi: 10.3201/eid2101.140894.

  PMID: 25530324 BACKGROUND

• Hirayama T, Mizuno Y, Takeshita N, Kotaki A, Tajima S, Omatsu T, Sano K, Kurane I, Takasaki T. Detection of dengue virus genome in urine by real-time reverse transcriptase PCR: a laboratory diagnostic method useful after disappearance of the genome in serum. J Clin Microbiol. 2012 Jun;50(6):2047-52. doi: 10.1128/JCM.06557-11. Epub 2012 Mar 21.

  PMID: 22442323 BACKGROUND

• Korhonen EM, Huhtamo E, Virtala AM, Kantele A, Vapalahti O. Approach to non-invasive sampling in dengue diagnostics: exploring virus and NS1 antigen detection in saliva and urine of travelers with dengue. J Clin Virol. 2014 Nov;61(3):353-8. doi: 10.1016/j.jcv.2014.08.021. Epub 2014 Sep 1.

  PMID: 25242312 BACKGROUND

• Magurano F, Zammarchi L, Baggieri M, Fortuna C, Farese A, Benedetti E, Fiorentini C, Rezza G, Nicoletti L, Bartoloni A. Chikungunya from the Caribbean: the importance of appropriate laboratory tests to confirm the diagnosis. Vector Borne Zoonotic Dis. 2015 Apr;15(4):258-60. doi: 10.1089/vbz.2014.1724.

  PMID: 25897812 BACKGROUND

• Mizuno Y, Kotaki A, Harada F, Tajima S, Kurane I, Takasaki T. Confirmation of dengue virus infection by detection of dengue virus type 1 genome in urine and saliva but not in plasma. Trans R Soc Trop Med Hyg. 2007 Jul;101(7):738-9. doi: 10.1016/j.trstmh.2007.02.007. Epub 2007 Apr 5.

  PMID: 17418320 BACKGROUND

• Panning M, Grywna K, van Esbroeck M, Emmerich P, Drosten C. Chikungunya fever in travelers returning to Europe from the Indian Ocean region, 2006. Emerg Infect Dis. 2008 Mar;14(3):416-22. doi: 10.3201/eid1403.070906.

  PMID: 18325256 BACKGROUND

• Van den Bossche D, Cnops L, Van Esbroeck M. Recovery of dengue virus from urine samples by real-time RT-PCR. Eur J Clin Microbiol Infect Dis. 2015 Jul;34(7):1361-7. doi: 10.1007/s10096-015-2359-0. Epub 2015 Mar 21.

  PMID: 25794553 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, urine

MeSH Terms

Conditions

Chikungunya Fever; Disease

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Bottieau, MD PhD

  Institute of Tropical Medicine, Antwerp, Belgium

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 22, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); AR (1)