A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB
NCT Number: NCT06526039
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Tuberculosis, Pulmonary
Interventions: OTHER: a novel short regimen
Sponsor: Taipei Medical University WanFang Hospital
Collaborators: Hualien Tzu Chi General Hospital|Chest Hospital, Ministry of Health and Welfare, Taiwan|Chang-Hua Hospital|Taichung Veterans General Hospital|Taichung Hospital, Ministry of Health and Welfare|Taoyuan General Hospital|Kaohsiung Veterans General Hospital.|Kaohsiung Medical University Chung-Ho Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2029-12

Summary:
To assess outcome of treatment and safety among patients with rifampicin-resistant isoniazid-susceptible pulmonary tuberculosis treated with a novel regimen consisting of isoniazid, bedaquiline, and moxifloxacin throughout for 6 months, supplemented by pyrazinamide for the initial 2 months.

Primary Outcome Measures: the proportion of patients with a favourable outcome at 12 months (53 weeks) post treatment initiation, The primary efficacy outcome measure is the proportion of patients with a favourable outcome at 12 months (53 weeks) post treatment initiation, 12 months after treatment initiation|the proportion of patients experiencing a grade 3 or greater adverse event during treatment and follow-up to 12 months (53 weeks) post treatment initiation., The primary safety outcome measure is the proportion of patients experiencing a grade 3 or greater adverse event, as defined by the CTCAE criteria except hyperuricemia which will be defined by the DAIDS criteria, during treatment and follow-up to 12 months (53 weeks) post treatment initiation., from treatment initiation to 12 months after treatment initiation
Secondary Outcome Measures: Sputum conversion, Time to sputum (smear and culture) conversion, through study completion, an average of 9 months|Time to unfavourable efficacy outcome, A patient's outcome will be classified as unfavourable if:

1. they are discontinued from their allocated study treatment and subsequently restarted on a different regimen,
2. treatment is extended beyond the scheduled end of treatment for any reason other than making up of missed treatment,
3. they are restarted on any MDR-TB treatment after the scheduled end of treatment,
4. they change their allocated study treatment for any reason other than the replacement of a single drug,
5. they die at any point up to 12 months post treatment initiation,
6. they have a positive culture result at 12 months post treatment initiation., through study completion, an average of 9 months|the proportion of patients with a favourable outcome at 24 months (105 weeks) post treatment initiation, The secondary efficacy outcome measure is the proportion of patients with a favourable outcome at 24 months (105 weeks) post treatment initiation., from treatment initiation to 24 months after treatment initiation|mortality during treatment and follow-up, All cause mortality during treatment and follow-up, from treatment initiation to 24 months after treatment initiation|Change of regimen for adverse drug reactions, The proportion of patients with a change of two or more drugs for adverse drug reactions, through study completion, an average of 9 months|Number of adverse drug reactions, The number of adverse drug reactions occurring on treatment, through study completion, an average of 9 months|Proportion of patients with treatment interruption for 2 months, The proportion of patients with treatment interruption for 2 or more months, through study completion, an average of 9 months