Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04899076
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2021-05-19
Brief Title:
Stool Processing Kit SPK Evaluation for Pediatric Tuberculosis TB
Sponsor:
Foundation for Innovative New Diagnostics Switzerland
Organization:
Foundation for Innovative New Diagnostics Switzerland
Study Overview
Official Title:
Multicentre Study to Evaluate the Diagnostic Accuracy of a Stool Processing Kit Combined With Xpert MTBRIF Ultra for Paediatric TB Diagnosis Using Microbiological Confirmation on Respiratory Samples as the Reference Standard
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MTBRIF 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
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 used at level 1 health facilities in low and middle income countries
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 MTBRIF Ultra combined with SPK for TB detection using microbiological confirmation on respiratory specimens defined as sputum naso-pharyngeal aspirate andor 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
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 MTBRIF Ultra combined with SPK for TB detection using microbiological confirmation on respiratory specimens defined as sputum naso-pharyngeal aspirate andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None