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TuberculosisNCT04899076

Stool Processing Kit (SPK) Evaluation for Pediatric Tuberculosis (TB)

An observational study of Tuberculosis, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 14 years
Conditions the study is for
Tuberculosis
What is being tested?
Stool Processing Kit
Type of treatment
Medical device
How many people
600 participants
Where
4 sitesin 3 countries
Study dates
19 Jun 2019to 31 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 14 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

India2 sites

  • All India Institute of Medical Sciences

    New Delhi

  • KEM Hospital Research Centre

    Pune

Other trials in India

South Africa1 site

  • University of Cape Town Lung Institute

    Cape Town

Other trials in South Africa

Uganda1 site

  • Mulago Hospital

    Kampala

Other trials in Uganda

About this study

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

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.

Read the 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 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
Tuberculosis
Being tested
Stool Processing Kit
Keywords
Diagnostics, Children
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stool Processing KitDevice

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

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 months

Secondary outcomes (6)

  1. 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)

    Measured: 2 months

  2. 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

    Measured: 2 months

  3. 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)

    Measured: 2 months

  4. 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)

    Measured: 2 months

  5. 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)

    Measured: 2 months

  6. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2021
  2. Study start19 Jun 2019
  3. Primary completion31 Mar 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04899076
Sponsor's protocol ID
7210-07-2/1
Status last verified
Nov 2023
First submitted
19 May 2021
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tuberculosis, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India, South Africa, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and specificity of a single Ultra/SPK using microbiological confirmation on respiratory specimens as reference standard (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04899076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.

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