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PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis

NCT04783727 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Pulmonary
  • Tuberculosis, Multidrug-Resistant
  • Bacterial Infections
  • Mycobacterial Infection

Interventions

DIAGNOSTIC_TEST

Individualised treatment duration based on RNA transcriptomic model

Anti-MDR-TB treatment with standard drugs and individual treatment duration guided by the RNA transcriptomic model; may be shorter or longer than standard WHO-recommended treatment duration of 20 months.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Research Center Borstel

    lead OTHER

Principal Investigators

  • Jan Heyckendorf, MD · Research Center Borstel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-11-01
Completion
2022-11-01

Countries

  • Germany
  • Moldova
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04783727 on ClinicalTrials.gov