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

• Study Start: 2020-03-20
• Last Update Posted: 2023-05-29

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