Commercial Typhoid Tests Validation

December 12, 2020 updated by: Dr. Robert Onsare, Kenya Medical Research Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

2000

Contacts and Locations

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

Study Contact

Study Locations

  • Kenya
      • Nairobi, Kenya, 254
        • Kenya Medical Research Institute

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

8 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The trial population will be composed of adults and children suspected of typhoid between 8-65 years of age. Participants will be recruited in 3 hospitals in Nairobi, Kenya.The three hospitals are in Nairobi County and include Mbagathi County Hospital, Mbagathi Road; Medical Missionaries of Mary, Reuben Centre Hospital in Mukuru Slum, Embakasi and City Council Clinic in Mukuru Slum, Embakasi.

Description

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

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: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point estimates of sensitivity and specificity for each test, with 95% confidence interval, using blood culture as reference standard.
Time Frame: At the end of the 6-month sampling period
Evaluation of different 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.
At the end of the 6-month sampling period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishment of a bio repository of well characterized specimen collection at the site available for future assessments of emerging technologies
Time Frame: At the end of the 6-month sampling period
Establishment of a bio repository of well characterized specimen collection that can be used to evaluate emerging tests.
At the end of the 6-month sampling period
Estimates of operational characteristics of different RDTs based on quantitative assessment including invalid and indeterminate rates
Time Frame: At the end of the 6-month sampling period
Evaluation of operational characteristics (invalid and indeterminate rates) of Typhoid RDTs
At the end of the 6-month sampling period

Collaborators and Investigators

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

Sponsor

Kenya Medical Research Institute

Collaborators

Foundation for Innovative New Diagnostics (FIND)

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

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 (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 12, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 12, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SERU 4076

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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