Tuberculosis
Conditions
Interventions
Standard of care
Individulised treatment group
Sponsors
UCT Lung Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Newly diagnosed culture and/or Xpert/MTB Ultra positive pulmonary TB • Rifampicin mono-resistance detected using the results from two susceptibility-testing assays (GeneXpert, HainMTBDRplus or phenotypic DST). This will be done on a sputum sample during screening, or with pre-existing results available from the local health care service. • Provide written informed consent prior to all trial-related procedures • Male or female aged 18 years and older. • Patients on TB treatment for less then 8 days.
Exclusion criteria
Exclusion 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 for more than 2 weeks. • Any participant with a clinically significant medical condition that, in the opinion of the investigator, may be negatively affected 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment initiation with at least 5 likely effective drugs within 14 days of diagnosis of rifampicin resistance;Six-month favourable outcome rate.;Twelve-month favourable outcome rate (overall primary outcome measure for the trial and at the end of stage 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Six-month culture conversion rates;Time to and rate of culture conversion ;Change in TB related morbidity over 6 months ;Amplification of drug resistance ;Time-point specific micro-hetero-resistance rates in each group;Accuracy and time to result of each resistance detection strategy;Feasibility, practicality, scalability and cost | — |
Countries
South Africa
Contacts
Public Contactali esmail
Clinical Trial Manager
Outcome results
None listed