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New treatment option for Pulmonary Tuberculosis
Official title A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
ClinicalTrials.gov ID: NCT07209761
What this study is testing
What is BPaQM?
BPaQM is an investigational medicine, given as an once-daily, being studied as a potential treatment for pulmonary tuberculosis.
Also referred to as Bedaquiline, Pretomanid, Quabodepistat, Moxifloxacin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB.
- Phase 3: a large, late-stage study
- Time commitment: about 16 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- Age ≥14 years
- Body weight ≥30.0 kg
- Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
- Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
- Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
You likely can't join if
- Known/suspected resistance to BDQ, PMD, LZD, or QBS
- Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
- Severe extrapulmonary TB
- Abnormal laboratory values: ALT/AST \>2.5×ULN, Total bilirubin \>1.5×ULN, eGFR \ 9.0%
- Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment
- Co-enrollment in other therapeutic trials
See the full eligibility criteria
- Age ≥14 years
- Body weight ≥30.0 kg
- Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
- Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
- Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
- Chest radiograph consistent with active TB disease
- Able to provide sputum sample
- Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
- Willing to have HIV test (unless previous positive result confirmed)
- For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load \ 100 cells/mL
- Known/suspected resistance to BDQ, PMD, LZD, or QBS
- Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
- Severe extrapulmonary TB
- Abnormal laboratory values: ALT/AST \>2.5×ULN, Total bilirubin \>1.5×ULN, eGFR \ 9.0%
- Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment
- Co-enrollment in other therapeutic trials
- QTcF \>450 msec (males) or \>470 msec (females)
- Clinically significant cardiovascular disorders
- Bleeding disorders
- Conditions interfering with X-ray or sputum assessment
- Drug allergies/hypersensitivity to study medications
- Pregnancy or breastfeeding
- Positive drug screen (case-by-case assessment for some substances)
- Serious mental disorders
- Karnofsky score \<60
- BMI \<16.0 kg/m²
- Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
- Pulmonary conditions other than TB (silicosis, fibrosis)
- Active SARS-CoV-2 infection
- Use of prohibited medications
- Blood/plasma donation within 30 days
- Current use of herbal remedies or traditional medicines
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Shenzhen, Guangdong, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tbilisi, Georgia
- Kiyose, Tokyo, Japan
- Chisinau, Chisinau City, Moldova
- La Molina, Lima region, Peru
- Villa El Salvador, Lima region, Peru
- Lima, Peru
- Silang, Cavite, Philippines
- San Fernando City, Central Luzon (Region III), Philippines
- Makati City, National Capital Region, Philippines
- Quezon City, National Capital Region, Philippines
- East London, Eastern Cape, South Africa
- Port Elizabeth, Eastern Cape, South Africa
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Shenzhen, Guangdong, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China; Jinan, Shandong, China and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.