Commercial Typhoid Tests Validation

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Brief Title

Commercial Typhoid Tests Validation

Official Title

Comparative Study of Commercially Available Typhoid Point of Care Tests to Benchmark Current and Emerging Tools

Brief Summary

      The study aims to perform a head to head comparison of 11 typhoid tests currently in the
      market and simultaneously develop a sample set that can be used in future evaluations of
      emerging technologies. The central objective is to evaluate different Typhoid Rapid
      Diagnostic Tests (RDTs) that are commercially available internationally for detecting
      antigens or antibodies to Salmonella Typhi and use Blood culture as standard for comparison.
      The end point will be to determine estimates of sensitivity and specificity for each test,
      with 95% confidence interval, using blood culture as reference.
    

Detailed Description

      Typhoid fever is an enteric bacterial infection caused by Salmonella enterica serovar Typhi
      (Salmonella Typhi; S. Typhi). It is an important infectious disease in low- and middle-income
      countries with over 10.9 million new cases worldwide and 116.8 thousand death in 2017. South
      Asia and Sub Saharan Africa are the most affected areas of the world. Typhoid fever is common
      in areas with inadequate sanitation and hygiene. In routine practice, diagnosis of typhoid
      fever is rarely confirmed as diagnostic tests are unavailable or have limited diagnostic
      accuracy. Blood culture is the commonest reference standard test but has a lower sensitivity.
      Alternatives to those methods exist but their performance is poor. The Widal test is still
      used but as it is based on cross-reactive antigens, it lacks sensitivity and specificity.
      Clinician often use rapid diagnostic tests to diagnose typhoid. A number of typhoid fever
      RDTs are commercially available but performance data are not available or not consistent from
      a study to another. This prospective, multicentre, cross-sectional study will be carried out
      in 3 hospitals of Nairobi, Kenya. 2000 clinically suspected typhoid cases will be enrolled in
      this study, blood culture as well as serum for RDT will be received. All typhoid positive and
      equal typhoid negative serum will be tested for investigational RDTs.

      This collaborative study between Kenya Medical Research Institute (KEMRI) and Foundation for
      Innovative New Diagnostics (FIND) will systematically compare different point of care typhoid
      tests currently available in the market against the same set of reference standard. The
      knowledge gained from this trial may benefit health providers' by providing information on
      diagnostic accuracy of current typhoid test and to decide on utility of these commercial
      tests. The result obtained from this trial will also be made available to help inform
      Ministry of Health in Kenya and the World Health Organization (WHO) Essential Diagnostic list
      (EDL) and stakeholder decision making more broadly.
    


Study Type

Observational


Primary Outcome

Point estimates of sensitivity and specificity for each test, with 95% confidence interval, using blood culture as reference standard.

Secondary Outcome

 Establishment of a bio repository of well characterized specimen collection at the site available for future assessments of emerging technologies

Condition

Typhoid Fever

Intervention

1. SD Bioline Salmonella Typhi IgG/IgM Fast test, 2. Typhidot Rapid IgG/IgM combo test, 3. TUBEX TF test, 4.Typhoid IgG/IgM Combo Rapid Test CE, 5. Enterocheck WB test, 6. Test-itTM Typhoid IgM test


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

2000

Start Date

January 2021

Completion Date

December 2021

Primary Completion Date

June 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Individuals aged 8 years of age to 65 years of age

          -  History of fever or axillary temperature of >37.5 °C for at least 3 consecutive days
             within the last 7 days prior to enrollment

          -  Clinical suspicion of enteric fever

          -  One of the following scenarios:

               -  Presents to outpatient department or Emergency Department

               -  Admitted to hospital within last 12 hours

          -  Able and willing to provide informed consent (and assent when required)

        Exclusion Criteria:

          -  Unwillingness to participate in the study

               -  Inability to provide the required volume of blood

               -  Unwillingness to provide blood

               -  Known non-infectious / Non typhoid Infectious causes of fever or other alternate
                  diagnosis of fever
      

Gender

All

Ages

8 Years - 65 Years


Contacts

, +254722337004, [email protected]

Location Countries

Kenya

Location Countries

Kenya

Administrative Informations


NCT ID

NCT04673487

Organization ID

SERU 4076


Responsible Party

Principal Investigator

Study Sponsor

Kenya Medical Research Institute

Collaborators

 Foundation for Innovative New Diagnostics (FIND)

Study Sponsor

, , 


Verification Date

December 2020