Status:

COMPLETED

Commercial Typhoid Tests Validation Trial

Lead Sponsor:

Foundation for Innovative New Diagnostics, Switzerland

Collaborating Sponsors:

Department for International Development, United Kingdom

Conditions:

Typhoid Fever

Eligibility:

All Genders

2-65 years

Brief Summary

Typhoid fever (typhoid) is an enteric bacterial infection caused by Salmonella enterica serovar Typhi (Salmonella Typhi; S. Typhi). It is one of the most common bacterial causes of acute febrile illne...

Detailed Description

Typhoid is an enteric disease caused by the bacterium Salmonella Typhi; it is estimated that 11 to 20 million people contract typhoid each year and 128 000 to 161 000 die from the disease; children un...

Eligibility Criteria

Inclusion

  • \- Individuals aged 8 years of age to 65 years of age
  • Body weight equals to or more than 8kgs
  • History of fever or axillary temperature of \>37.50C for at least 3 consecutive days within the last 7 days prior to enrolment
  • 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

  • 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
  • Taking anticoagulant drugs
  • Unconscious

Key Trial Info

Start Date :

October 25 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2021

Estimated Enrollment :

3091 Patients enrolled

Trial Details

Trial ID

NCT04801602

Start Date

October 25 2020

End Date

December 31 2021

Last Update

May 24 2022

Active Locations (2)

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Page 1 of 1 (2 locations)

1

KEMRI

Nairobi, Kenya

2

Aga Khan University

Karachi, Sindh, Pakistan