Status:
NOT_YET_RECRUITING
A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB
Lead Sponsor:
Taipei Medical University WanFang Hospital
Collaborating Sponsors:
Hualien Tzu Chi General Hospital
Chest Hospital, Ministry of Health and Welfare, Taiwan
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 m...
Detailed Description
Rifampicin-resistant tuberculosis (RR-TB) could be classified into rifampicin-resistant, isoniazid-susceptible TB (RrHs-TB) and rifampicin-resistant, isoniazid-resistant TB (MDR-TB), that is MDR-TB. R...
Eligibility Criteria
Inclusion
- A patient will be eligible for entry to the study if he/she:
- 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.
- With initial laboratory result of being susceptible to rifampicin by Xpert MTB/RIF or other DST (Xpert MTB/RIF ultra, line probe assay, culture) but are not able to tolerate rifampicin for whom rifabutin is intolerable or clinically not indicated; and with initial laboratory result that is susceptible to isoniazid by Xpert MTB/RIF or other DST
- With initial laboratory result of being susceptible to rifampicin by Xpert MTB/RIF or other DST (Xpert MTB/RIF ultra, line probe assay, culture) but rifamycin-sparing regimens are preferred due to drug-drug interaction, such as organ transplant recipients; and with initial laboratory result that is susceptible to isoniazid by Xpert MTB/RIF or other DST.
- With initial laboratory result that is susceptible to fluoroquinolone by Xpert MTB/XDR or other DST.
- If HIV test positive, is willing to be treated with ART in accordance with the national policies.
- Agrees to use effective barrier contraception or have an intrauterine contraceptive device during treatment phase if a pre-menopausal woman
- Has an identifiable address and expects to remain in the area for the duration of the study
- Is willing to adhere to the follow-up schedule and to study procedures
Exclusion
- A patient will not be eligible for entry to the study if he/she:
- 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
- Is critically ill, and in the judgment of the investigator, unlikely to survive more than 4 months.
- Is known to be pregnant or breast-feeding
- Is unable to attend or comply with treatment or follow-up schedule
- Is unable to take oral medication
- Has AST or ALT \>5 times the upper limit of normal
- Has AST or ALT \> 3 times the upper limit of normal ,and either with symptoms of hepatitis or bilirubin \> 1.5 times the upper limit of normal
- Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe.
- Is taking any medications contraindicated with the medicines in either the trial or control regimen
- Has a known allergy to any fluoroquinolone antibiotic
- Is currently taking part in another trial of a medicinal product
- Has a QTcF interval of ≥450msec at screening
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06526039
Start Date
July 1 2024
End Date
December 1 2029
Last Update
July 29 2024
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