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
Qualifiers
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
Treatments tested in this trial
- a novel short regimen
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
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