NCT04899076

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 be assessed using a microbiological reference standard and a composite reference standard among children with signs and symptoms of pulmonary tuberculosis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

May 19, 2021

Last Update Submit

November 21, 2023

Conditions

Tuberculosis

Keywords

DiagnosticsChildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Diagnostic accuracy of a single Ultra/SPK using the National Institutes of Health (NIH) consensus definition as reference standard

    2 months

  • Diagnostic accuracy of a single Ultra/SPK for Rifampin resistance detection

    2 months

  • Additional yield (increase in sensitivity) of a 2nd Ultra/SPK

    2 months

  • Diagnostic accuracy of a single Ultra/SPK for TB detection per subgroup

    2 months

  • Diagnostic accuracy of additional interventions: Simple One Step (SOS), Optimized Sucrose Flotation (OSF) and Fujifilm SILVAMP TB LAM

    2 months

  • +1 more secondary outcomes

Interventions

Stool Processing KitDEVICE

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

Also known as: Simple One Step (KNCV), Optimized Sucrose Flotation (TB-Speed), Fujifilm SILVAMP TB LAM

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children who are 14 years of age or younger who present with signs and symptoms of pulmonary TB, or have microbiological confirmation of active tuberculosis (TB) and are referred to enrollment sites

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

All India Institute of Medical Sciences

New Delhi, India

Location

KEM Hospital Research Centre

Pune, India

Location

University of Cape Town Lung Institute

Cape Town, South Africa

Location

Mulago Hospital

Kampala, Uganda

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Morten Ruhwald, MD

    Find

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

June 19, 2019

Primary Completion

March 31, 2021

Study Completion

October 31, 2021

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)UG(1)IN(2)