A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB (NCT06526039) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB
100 participantsStarted 2024-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 Xā¦
What they're measuring
1
the proportion of patients with a favourable outcome at 12 months (53 weeks) post treatment initiation
Timeframe: 12 months after treatment initiation
2
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.
Timeframe: from treatment initiation to 12 months after treatment initiation