Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course regimens (BDLLfxC or BDCZ) in patients with multidrug-resistant tuberculosis (MDR-TB).
The primary objectives are to assess the safety and tolerability of AHA combined with short-course regimens, and to determine the recommended phase II dose (RP2D) of AHA.
The secondary objectives include evaluating the 8-week sputum culture conversion rate, pharmacokinetic parameters, and exploring DNA damage repair biomarkers as potential indicators of treatment response.
Eligibility criteria
Qualifiers
Age 14 to < 65 years, male or female
Confirmed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) by molecular testing (e.g., Xpert MTB/RIF) or drug susceptibility testing
Positive sputum culture for Mycobacterium tuberculosis or positive molecular test
Chest imaging consistent with active pulmonary TB, or histologically confirmed extrapulmonary TB (excluding CNS, osteoarticular, and disseminated TB)
Disqualifiers
Central nervous system TB (e.g., TB meningitis), osteoarticular TB, or disseminated/miliary TB
Known allergy or serious adverse reaction to any study drug or background regimen component
Known resistance to bedaquiline, delamanid, or linezolid
Use of anti-TB drugs within the past 30 days that may interfere with study assessments, except in documented treatment failure cases
Trial design
Treatments tested in this trial
- Acetohydroxamic Acid
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov