Evaluation of Four Stool Processing Methods Combined With Xpert MTB/RIF Ultra for Diagnosis of Intrathoracic Paediatric TB (TB-Speed - Stool Processing)

Summary

There is a growing interest for the use of stool samples as an alternative to respiratory samples for the diagnosis of intrathoracic TB in children unable to produce sputum. Unlike respiratory samples, stool samples require processing before molecular testing. Several groups have already evaluated different processing methods. However, it is difficult to know which method has the best accuracy and potential for use at Primary Health Care level, due to the difference in study designs and populations. Therefore, in this study, the investigators propose to evaluate the accuracy of different promising stool processing methods in the same population within the same study with an adapted design. Furthermore, no study has so far evaluated for stool testing the new Xpert MTB/RIF Ultra cartridge that has a lower level of detection than the previous Xpert MTB/RIF cartridge. The investigators propose to evaluate the accuracy of Xpert MTB/RIF Ultra (Ultra) performed on stool samples collected from children with presumptive TB and processed using four different processing methods (Standard sucrose flotation method, optimized sucrose flotation method, SPK, and SOS) against bacteriological results from respiratory specimens and to perform a head-to-head comparison of the diagnostic accuracy and feasibility of these different methods in Uganda and Zambia. The selection of processing methods was based on accuracy results, degree of simplification allowing their introduction at PHC level, and finding from the TB-Speed in-vitro stool processing study. The standard sucrose flotation method is kept to assess if results obtained with the optimised sucrose-flotation method in our in-vitro study can be reproduced in-vivo

Conditions

• Tuberculosis

Interventions

DIAGNOSTIC_TEST

Xpert MTB/Rif Ultra on stool samples

The Xpert MTB/Rif Ultra will be performed on stool samples processed using four different processing methods: * Standard sucrose flotation method * Optimized sucrose flotation * Stool processing kit (SPK) * Simple One-step method (SOS)

DIAGNOSTIC_TEST

Xpert MTB/Rif Ultra on respiratory sample

The Xpert MTB/Rif Ultra will be performed on gastric aspirate or expectorated sputum

Sponsors & Collaborators

• UNITAID

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  lead OTHER_GOV

Principal Investigators

• Maryline Bonnet, MD, PhD · Institut de Recherche pour le Développement (IRD) Montpellier, France

• Olivier Marcy, MD, PhD · University of Bordeaux, France

• Eric Wobudeya, MD, PhD · MU-JHU Care Ltd, Kampala, Uganda

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-13

Primary Completion

2022-02-07

Completion

2022-02-07

Countries

• Uganda
• Zambia

Study Locations