Status:
COMPLETED
Stool Processing Kit (SPK) Evaluation for Pediatric Tuberculosis (TB)
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
Mulago Hospital, Uganda
University of Cape Town Lung Institute
Conditions:
Tuberculosis
Eligibility:
All Genders
Up to 14 years
Brief Summary
This is a prospective, multicenter cohort study in which the accuracy and the diagnostic yield of the Stool Processing Kit (SPK) in combination with Xpert Ultra MTB/RIF (Ultra) on stool samples will b...
Detailed Description
FIND and partners have developed a simple Stool Processing Kit (SPK) that will enable processing of large numbers of stool samples, removal of PCR (polymerase chain reaction) inhibitors which can be u...
Eligibility Criteria
Inclusion
- Children of 14 years of age or younger
- Written parent/guardian consent and child assent based on age and national ethical guidelines
- Willingness to have a study follow-up visit
- Clinical suspicion of active pulmonary TB\* OR microbiological confirmation of active TB disease referred from non-study health facilities
- Chest X-ray suggestive of TB, or weight loss or failure to thrive within 3 months not solely due to inadequate feeding, or another non-TB cause, or any cough with loss of weight, or cough alone \>=14 days, or persistent (\>1 week) and unexplained fever
Exclusion
- Anti-TB treatment for \>5 days or any antibiotic with anti-mycobacteria activity within 60 days prior to enrollment including children on Isoniazid Preventive Therapy
- (confirmed) extra-pulmonary TB only
Key Trial Info
Start Date :
June 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04899076
Start Date
June 19 2019
End Date
October 31 2021
Last Update
November 24 2023
Active Locations (4)
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1
All India Institute of Medical Sciences
New Delhi, India
2
KEM Hospital Research Centre
Pune, India
3
University of Cape Town Lung Institute
Cape Town, South Africa
4
Mulago Hospital
Kampala, Uganda