Tuberculosis Clinical Trial
Official title:
Multicentre Study to Evaluate the Diagnostic Accuracy of a Stool Processing Kit Combined With Xpert MTB/RIF Ultra for Paediatric TB Diagnosis Using Microbiological Confirmation on Respiratory Samples as the Reference Standard
NCT number | NCT04899076 |
Other study ID # | 7210-07-2/1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 19, 2019 |
Est. completion date | October 31, 2021 |
Verified date | November 2023 |
Source | Foundation for Innovative New Diagnostics, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 be assessed using a microbiological reference standard and a composite reference standard among children with signs and symptoms of pulmonary tuberculosis.
Status | Completed |
Enrollment | 600 |
Est. completion date | October 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 14 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences | New Delhi | |
India | KEM Hospital Research Centre | Pune | |
South Africa | University of Cape Town Lung Institute | Cape Town | |
Uganda | Mulago Hospital | Kampala |
Lead Sponsor | Collaborator |
---|---|
Foundation for Innovative New Diagnostics, Switzerland | All India Institute of Medical Sciences, New Delhi, KEM Hospital Research Centre, Mulago Hospital, Uganda, University of California, San Francisco, University of Cape Town Lung Institute |
India, South Africa, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of a single Ultra/SPK using microbiological confirmation on respiratory specimens as reference standard | Point estimates of sensitivity and specificity with 95% confidence intervals, using microbiological confirmation including two cultures and two Xpert MTB/RIF Ultra in respiratory samples | 2 months | |
Secondary | Diagnostic accuracy of a single Ultra/SPK using the National Institutes of Health (NIH) consensus definition as reference standard | Point estimates of sensitivity and specificity with 95% confidence intervals, using the Revised Classification NIH classification for diagnostic evaluation studies in children (Graham et al., CID 2015) | 2 months | |
Secondary | Diagnostic accuracy of a single Ultra/SPK for Rifampin resistance detection | Point estimates of sensitivity and specificity with 95% confidence intervals, with the Mycobacteria Growth Indicator Tube (MGIT) Drug Susceptibility Testing (DST) on respiratory specimens as reference standard | 2 months | |
Secondary | Additional yield (increase in sensitivity) of a 2nd Ultra/SPK | Sensitivity of a 2nd sampling on the same stool with Ultra/SPK for TB and RIF resistance detection using the different reference standards (Outcome 1 & 2) | 2 months | |
Secondary | Diagnostic accuracy of a single Ultra/SPK for TB detection per subgroup | Sensitivity and specificity of Ultra/SPK by sample, by site, by smear status, by HIV status, by TB history, by stool consistency, and by age using the different reference standards (Outcome 1 & 2) | 2 months | |
Secondary | Diagnostic accuracy of additional interventions: Simple One Step (SOS), Optimized Sucrose Flotation (OSF) and Fujifilm SILVAMP TB LAM | Sensitivity and specificity, by intervention using the different reference standards (Outcome 1 & 2) and by subgroup (Outcome 5) | 2 months | |
Secondary | Feasibility and user appraisal of the different stool processing methods | Assessment of user appraisal on ease of use and potential implementation of stool processing methods using a standardized questionnaire | 6 months |
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