Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis

Launched by UNIVERSITY OF CAPE TOWN · Aug 13, 2021

Keywords

ClinConnect Summary

This clinical trial, called "Test to Treat TB," is studying a new way to help patients with drug-resistant tuberculosis (TB). TB can be hard to treat when it doesn't respond to standard medications, and current testing methods for resistance are slow and often limited in what they can detect. The trial aims to see if a new approach using advanced DNA sequencing from sputum (the mucus you cough up) can better identify which drugs a patient may still respond to. By doing this, doctors can tailor treatments specifically to each patient, potentially improving their chances of recovery.

To participate in this trial, individuals must be at least 18 years old, have a confirmed diagnosis of pulmonary TB with rifampicin resistance, and have started TB treatment for no more than 7 days. Participants will undergo various tests to compare the new sequencing method with current testing practices. The trial is not yet recruiting, but it will help determine if this innovative approach can lead to better treatment outcomes for those struggling with drug-resistant TB.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects are required to meet ALL of the following inclusion criteria to participate:
• • Newly diagnosed culture and/or Xpert/MTB Ultra positive pulmonary TB
• • Rifampicin resistance detected using GeneXpert
• • Provide written informed consent prior to all trial-related procedures
• • Male or female aged 18 years and older.
• • Patients on TB treatment for less than or equal to 7 days.
• • Patients receiving both the shorter and longer MDR-TB regimen will be eligible.
• Exclusion Criteria:
• Subjects will be excluded from participation if they meet ANY of the following criteria:
• • A subject who in the opinion of the investigator is unlikely to cope with regular visits to the trial site either because of travel constraints, or drug or alcohol abuse, or other reason.
• • Currently on MDR-TB treatment and completed 7 days of treatment.
• • Any participant with a clinically significant pre-existing medical condition that, in the opinion of the investigator, may be significantly worsened by the patient's participation in the study
• • Any subject with a Karnofsky score \< 50.
• • Having participated in other clinical studies within 8 weeks prior to trial start where investigational agents were used that may potentially impact current trial outcome.
• • Participant who is pregnant, breast-feeding (and not willing to stop), or planning to conceive a child within 6 months of cessation of treatment.
• • Any pre-existing laboratory abnormality, which in the opinion of the investigator will place the participant at risk (see detailed protocol for grade of abnormality).