Status:
TERMINATED
PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis
Lead Sponsor:
Research Center Borstel
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
Conditions:
Tuberculosis, Pulmonary
Tuberculosis, Multidrug-Resistant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utili...
Detailed Description
This study is a non-inferiority, prospective, parallel-group open-label randomized controlled trial. Three hundred forty-two HIV-negative patients diagnosed with pulmonary tuberculosis (TB) and starti...
Eligibility Criteria
Inclusion
- Patient starting an MDR-TB treatment or within the first 4 weeks after treatment initiation and before culture conversion.
- Rifampicin resistant M. tuberculosis detected in sputum using a nucleic acid amplification test.
- New case of TB or re-treatment.
- Can give informed consent at the point of recruitment.
- Contactable (residing in the area covered by participating TB centres and possessing a landline or a mobile phone).
- Willing to participate for the entire course of the treatment and extensive follow-up.
Exclusion
- Age \<18 years old.
- Anti-MDR-TB therapy within 6 months prior to the start date of the current treatment cycle.
- HIV infection.
- Non-adherent patient with frequent interruptions.
- Patient in custodianship or guardianship.
- Late exclusion criterion: no positive cultures at inclusion and within the first 3 months of treatment.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04783727
Start Date
April 1 2021
End Date
November 1 2022
Last Update
December 13 2023
Active Locations (5)
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1
Research Center Borstel
Borstel, Schleswig-Holstein, Germany, 23845
2
Phthisiopneumology Institute Chiril Draganiuc
Chisinau, Moldova, 2025
3
Marius Nasta Pulmonology Institute
Bucharest, Romania
4
Kharkiv National Medical University
Kharkiv, Ukraine, 61000