PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis

  • STATUS
    Recruiting
  • End date
    Mar 14, 2026
  • participants needed
    342
  • sponsor
    Research Center Borstel
Updated on 14 April 2021

Summary

PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic signature-based model compared to the standardised twenty months treatment in a cohort of multidrug-resistant tuberculosis patients.

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 starting a new anti-multidrug-resistant tuberculosis (MDR-TB) treatment cycle will be included in the study. Two randomized arms of 171 patients each will be recruited over the two-year period, each patient will be followed-up over the entire course of anti-TB treatment and one year after the end of therapy. Regular study visits will include physical examination, collection of sputum, blood and urine and filling in the study questionnaire. On the collected specimens standard bacteriological and blood tests, as well as extended immunological analysis, will be performed. In the experimental group, an RNA transcriptomic analysis using RNA-Seq technology will also be performed.

In the control arm, the patients will receive a standardised World Health Organization recommended 20 months treatment while in the experimental arm the treatment duration will be guided by the transcriptomic signature-based model.

Treatment outcomes and level of TB relapse and survival within the follow-up period will be compared between the experimental and control arms. The efficacy of biomarker-guided treatment therapy will be assessed by a comparison of the proportions of favourable study outcome between two arms.

Details
Condition Bacterial Infection, Bacterial Infections, drug-resistant tuberculosis, Mycobacterium, Mycobacterial infection, Pulmonary tuberculosis, Bacterial Infections, bacterial disease
Treatment Individualised treatment duration based on RNA transcriptomic model
Clinical Study IdentifierNCT04783727
SponsorResearch Center Borstel
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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