A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB
ConditionTuberculosis, Pulmonary
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University WanFang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Is willing and able to give informed consent to be enrolled in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate)
Is aged 18 years or older
Has bacteriologically-confirmed pulmonary tuberculosis by Xpert MTB/RIF, other nucleic acid amplification test, or culture
With initial laboratory result of resistance to rifampicin by Xpert MTB/RIF or Xpert MTB/RIF ultra, or other DST (line probe assay, culture); and with initial laboratory result that is susceptible to isoniazid by Xpert MTB/RIF or other DST. If rifampicin resistance is detected by Xpert MTB/RIF or Xpert MTB/RIF ultra in specimens with very low bacillary, rifampicin resistance has been confirmed by a repeat molecular test.
Disqualifiers
Is infected with a strain of M. Tuberculosis resistant to isoniazid by Xpert MTB/XDR or other tests
Is infected with a strain of M. Tuberculosis resistant to fluoroquinolone by Xpert MTB/XDR or other tests
Is infected with a strain of M. Tuberculosis resistant to amikacin by Xpert MTB/XDR or other tests and have no result of susceptibility of isoniazid by conventional drug susceptibility testing
Has tuberculous meningitis or bone and joint tuberculosis
Trial design
Design model
Single group
Treatments tested in this trial
a novel short regimen
Other interventionAn intensive phase consisting of isoniazid, bedaquiline, moxifloxacin and pyrazinamide for 2 months (9 weeks). A continuation phase consisting of isoniazid, bedaquiline, and levofloxacin for 4 months (17 weeks). Treatment may be extended for 3 months (13 weeks) in patients with severe disease or with delayed culture conversion, defined by culture positive at 4 months of treatment.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 months after treatment initiation2
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.
Time frame
from treatment initiation to 12 months after treatment initiationSecondary outcomes
1
Sputum conversion
Time to sputum (smear and culture) conversion
Time frame
through study completion, an average of 9 months2
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.
Time frame
through study completion, an average of 9 months3
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.
Time frame
from treatment initiation to 24 months after treatment initiation4
mortality during treatment and follow-up
All cause mortality during treatment and follow-up
Time frame
from treatment initiation to 24 months after treatment initiationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Taipei Medical University WanFang Hospital
Lead sponsor
Hualien Tzu Chi General Hospital
Collaborator
Chest Hospital, Ministry of Health and Welfare, Taiwan
Collaborator
Chang-Hua Hospital
Collaborator
Taichung Veterans General Hospital
Collaborator
Taichung Hospital, Ministry of Health and Welfare
Collaborator
Taoyuan General Hospital
Collaborator
Kaohsiung Veterans General Hospital.
Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: