TB-Speed - Stool Processing

Not Applicable

Recruiting

• Conditions: Tuberculosis; Respiratory; Paediatrics

• Registration Number: PACTR202006814433059
• Lead Sponsor: INSERM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

For the prospective cohort:
Children < 15 years old
Presumptive intra-thoracic TB based on at least one criterion among the following:
- Persistent cough for more than 2 weeks
- Persistent fever for more than 2 weeks
- Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age < 2)
- Failure of broad-spectrum antibiotics for treatment of pneumonia
- Suggestive CXR features
- OR History of contact with a TB case and any of the symptoms listed under point 2 with shorter duration (< 2 weeks) if the child is HIV infected or presents with SAM.
Signed informed consent by parent or guardian and assent signed by children > 7 years old
For the enrichment cohort:
Children < 15 years old
Presumptive intra-thoracic TB based on at least one criterion among the following:
- Persistent cough for more than 2 weeks
- Persistent fever for more than 2 weeks
- Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age < 2)
- Failure of broad-spectrum antibiotics for treatment of pneumonia
- Suggestive CXR features
- OR History of contact with a TB case and any of the symptoms listed under point 2 with shorter duration (< 2 weeks) if the child is HIV infected or presents with SAM
One positive Xpert (MTB/Rif or Ultra) result from at least one respiratory sample: sputum or GA
Signed informed consent by parent or guardian and assent signed by children > 7 years old

Exclusion Criteria

> 5 days of antituberculosis treatment in the last 3 months
History of tuberculosis preventive therapy in the last 3 months
Confirmed extrapulmonary TB only

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and sensibility of Ultra on stool using TB culture reference standard (Löwenstein–Jensen medium and Mycobacteria Growth Indicator Tube) in two respiratory samples (two sputums or two gastric aspirates according the age of the child).