Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
Condition(s) studied
Investigational drug(s) / intervention(s)
Acetohydroxamic Acid: Acetohydroxamic acid administered according to the protocol-defined dose and schedule, in combination with a short-course anti-tuberculosis regimen.
Placebo: Matching placebo identical in appearance, packaging, and administration schedule to acetohydroxamic acid, administered with the same short-course anti-tuberculosis regimen.
Study summary
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
Primary outcome measure(s)
- Change in Mycobacterium tuberculosis sputum bacterial load — Baseline to Day 14
Change in quantitative Mycobacterium tuberculosis colony-forming units (CFU) in sputum, expressed as log10 CFU/mL/day, measured using standardized microbiological culture methods.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Chest Hospital | Hefei | Anhui | |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality |
More Shanghai Pulmonary Hospital, Shanghai, China trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07393438 on ClinicalTrials.gov ↗ ← All trials in China