Not Yet RecruitingPhase 2

Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)

China120 participantsStarted 2026-02-21

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) * Body weight ≥ 40 kg * Karnofsky Performance Status ≥ 50 * Adequate laboratory parameters: * Hemoglobin ≥ 8.0 g/dL * ANC ≥ 1000/mm³ * Platelets ≥ 75,000/mm³ * ALT/AST ≤ 3 × ULN * Total bilirubin ≤ 2 × ULN * Creatinine clearance ≥ 30 mL/min * QTcF interval \< 450 ms (male) or \< 470 ms (female) * HIV-negative, confirmed by approved testing * No prior exposure to bedaquiline, delamanid, or linezolid for more than 1 month * Female participants of childbearing potential must agree to use effective contraception and have a negative pregnancy test * Signed informed consent Exclusion Criteria: * 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 * Severe comorbidities, including: * NYHA Class III-…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Mycobacterium tuberculosis sputum bacterial load

Timeframe: Baseline to Day 14

Trial details

NCT IDNCT07393438

SponsorShanghai Pulmonary Hospital, Shanghai, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-28

Contact for this trial

liu yidian, MD

021-65115006 liuyidian115@139.com

View on ClinicalTrials.gov More Multidrug-Resistant Tuberculosis trials