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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Acetohydroxamic Acid
DrugAcetohydroxamic acid administered according to the protocol-defined dose and schedule, in combination with a short-course anti-tuberculosis regimen.
Placebo
DrugMatching placebo identical in appearance, packaging, and administration schedule to acetohydroxamic acid, administered with the same short-course anti-tuberculosis regimen.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: AHA plus Short-Course RegimenExperimental treatment 1 intervention
Group B: Placebo plus Short-Course RegimenPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Mycobacterium tuberculosis sputum bacterial load
Change in quantitative Mycobacterium tuberculosis colony-forming units (CFU) in sputum, expressed as log10 CFU/mL/day, measured using standardized microbiological culture methods.
Time frame
Baseline to Day 14Secondary outcomes
1
Time to sputum culture conversion
Time from treatment initiation to the first of two consecutive negative Mycobacterium tuberculosis sputum cultures collected at least 24 hours apart, assessed using standardized culture methods.
Time frame
Baseline to Week 8Other outcomes
1
Peak Plasma Concentration (Cmax)
Measurement of peak plasma concentration (Cmax) of acetohydroxamic acid using protocol-specified sampling and validated analytical methods.
Time frame
Baseline to Day 142
Changes in inflammatory biomarkers
Changes in serum inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and other protocol-specified cytokines.
Time frame
Baseline to Day 143
Radiographic Severity Score on Chest X-ray or CT
Radiographic severity score assessed using a standardized scoring system evaluating extent of pulmonary involvement. Higher scores indicate more severe radiographic abnormalities.
Time frame
Baseline to Week 84
Time to Peak Concentration (Tmax)
Measurement of time to peak plasma concentration (Tmax) of acetohydroxamic acid based on protocol-defined pharmacokinetic sampling.
Time frame
Baseline to Day 14Sponsors and contacts
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Source ClinicalTrials.gov
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