BridgeMD
New treatment option for Pulmonary Tuberculosis
Official title A PAN-USR TB Multi-Center Trial
ClinicalTrials.gov ID: NCT06905522
What this study is testing
What is Bedaquiline (B)?
Bedaquiline (B) is an investigational medicine, given as an once-daily, being studied as a potential treatment for pulmonary tuberculosis.
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
- Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide. China is among the countries with the highest TB burden, ranking third globally for total TB cases and second for drug-resistant TB cases.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age range from 18 to 65 years old, regardless of gender;
- Clinical symptoms and/or pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;
- Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, whether resistant to rifampicin or not...
- Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;
- Willing to undergo HIV testing;
You likely can't join if
- Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including...
- Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones [including moxifloxacin, sitagliptin]...
- Resistance to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones [including moxifloxacin, sitagliptin], pyrazinamide). The...
- Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of...
- Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;
- Simultaneously using drugs that affect the how well it works of this study or have contraindications for combination therapy;
See the full eligibility criteria
- Age range from 18 to 65 years old, regardless of gender;
- Clinical symptoms and/or pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;
- Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, whether resistant to rifampicin or not; Recommend using respiratory specimens for GeneXpert MTB/RIF testing;
- Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;
- Willing to undergo HIV testing;
- Willing to preserve samples including DNA;
- For women with fertility, they have a negative serum or urine pregnancy test within 3 days before enroll the study and be willing to use effective contraceptive measures during the study period. Female people without...
- Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs);
- Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones [including moxifloxacin, sitagliptin], pyrazinamide);
- Resistance to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones [including moxifloxacin, sitagliptin], pyrazinamide). The following detection methods can be used: tNGS or other drug sensitivity...
- Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary...
- Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;
- Simultaneously using drugs that affect the how well it works of this study or have contraindications for combination therapy;
- Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening;
- Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole...
- Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers;
- HIV positive;
- Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors;
- Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT levels ≥ 3 times the upper limit of normal (ULN); (2) Blood creatinine ≥ 2 times ULN; (3) Hemoglobin ≤ 70 g/L; (4) Platelet count ≤ 50 ×...
- ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia...
- Women who are pregnant or breastfeeding;
- Weight \<30 kg, or ≥90 kg;
- The patient has participated in clinical trials of other drugs within the past 3 months during the screening period;
- Other conditions deemed unsuitable for participation in the study by the research doctors.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Shenzhen, China
- Ürümqi, China
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Shenzhen, China; Ürümqi, China. 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.