NCT07393438Not yet recruitingPhase 2
Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
Acetohydroxamic Acid Combined With a Short-Course Regimen for the Treatment of Multidrug-Resistant Tuberculosis: A Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 21 Feb 2026
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Diseases
- Tuberculosis
- NCT number
- NCT07393438
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 21 Feb 2026 to the primary completion date, 28 Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of MAO inhibitors or serotonergic drugs
Other illness
- Known allergy or serious adverse reaction to any study drug or background regimen component
- Use of anti-TB drugs within the past 30 days that may interfere with study assessments, except in documented treatment failure cases
- Any condition that, in the investigator's judgment, may interfere with study completion or data interpretation
Lab values
- Severe comorbidities, including:
- NYHA Class III-IV heart failure
- History or risk factors for Torsades de Pointes
- Child-Pugh B or C cirrhosis
- Uncontrolled diabetes (HbA1c \> 10%)
- Active malignancy
- Current use of QT-prolonging medications that cannot be substituted
Other
- Central nervous system TB (e.g., TB meningitis), osteoarticular TB, or disseminated/miliary TB
- Known resistance to bedaquiline, delamanid, or linezolid
- BMI \< 17 kg/m² with severe malnutrition
- Grade 3-4 peripheral neuropathy at baseline
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Chest Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.