Stool Processing Kit (SPK) Evaluation for Pediatric Tuberculosis (TB)
NCT ID: NCT04899076
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2019-06-19
2021-10-31
Brief Summary
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Detailed Description
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The SPK is not a diagnostic kit as such but rather a sample processing method. This study aims to determine the sensitivity and specificity of Xpert Ultra MTB/RIF (Ultra) combined with SPK for TB detection using microbiological confirmation on respiratory specimens (defined as sputum, naso-pharyngeal aspirate, and/or gastric aspirate) as the reference standard. The investigators will further evaluate operational characteristics, including implementation considerations that will be needed for the potential rollout of the SPK.
Additionally, a comparison of the performance of the SPK with up to two other centrifuge-free stool processing methods will be done on the same stool samples. The first is a method developed by researchers at the KNCV Tuberculosis Foundation (Single One Step Stool) which does not require any additional reagents other than the Ultra Sample Reagent. The second is a method developed by the Pediatric Asian African Network for Tuberculosis and HIV Research (PANTHER) group, the Optimized Sucrose Flotation method. Another diagnostic candidate, the urine Fujifilm SILVAMP TB LAM (FujiLAM) test will be assessed during the study.
Therefore, if the sensitivity of any of these tests is shown to be promising this may support further research and provide other alternatives to respiratory samples.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Stool Processing Kit
The Stool Processing Kit is a centrifuge-free stool processing solution that allows preparation of stool samples for testing with the Xpert Ultra MTB/RIF assay
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* (confirmed) extra-pulmonary TB only
14 Years
ALL
No
Sponsors
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Mulago Hospital, Uganda
OTHER
University of Cape Town Lung Institute
OTHER
University of California, San Francisco
OTHER
All India Institute of Medical Sciences
OTHER
KEM Hospital Research Centre
OTHER
Foundation for Innovative New Diagnostics, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Morten Ruhwald, MD
Role: STUDY_DIRECTOR
Find
Locations
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All India Institute of Medical Sciences
New Delhi, , India
KEM Hospital Research Centre
Pune, , India
University of Cape Town Lung Institute
Cape Town, , South Africa
Mulago Hospital
Kampala, , Uganda
Countries
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Other Identifiers
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7210-07-2/1
Identifier Type: -
Identifier Source: org_study_id