A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB

Launched by TAIPEI MEDICAL UNIVERSITY WANFANG HOSPITAL · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment plan for patients with a specific type of tuberculosis (TB) known as rifampicin-resistant, isoniazid-susceptible pulmonary TB. The study aims to find out how well a combination of three medications—isoniazid, bedaquiline, and moxifloxacin—works when taken for six months, with an additional medication, pyrazinamide, for the first two months. The goal is to assess both the effectiveness of this treatment and its safety for patients.

To participate in this trial, you must be 18 years or older and have a confirmed diagnosis of pulmonary TB that is resistant to rifampicin but still susceptible to isoniazid. You'll also need to be willing to follow the study procedures and attend regular check-ups. However, individuals with certain conditions, such as those who cannot take oral medications or are pregnant, will not be eligible. If you qualify, you can expect close monitoring during the treatment period and support from the study team to help ensure your safety and health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 Criteria:
• 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