Multidrug Resistance TubercolosisTBETNCT07296055
Endobronchial Valve in Tubercular and NTM Pulmonary Cavities.
A study testing Endobronchial valves in people with Multidrug Resistance Tubercolosis and Non Tubercolar Micobacteriosis, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Tuberculosis (TB) is a complex disease in which the lungs are the primary site of infection. Infection is acquired through inhalation of droplet nuclei laden with Mycobacterium bacilli (M. tuberculosis) that settle in the alveoli as the primary focus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multidrug Resistance Tubercolosis, Non Tubercolar Micobacteriosis
- What is being tested?
- Endobronchial valves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2026to 12 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years AND
- Patient with cavities deemed unsuitable for surgery (when an extensive pulmonary parenchymal damage due to TB, is present, making patients inappropriate for open thoracic surgery) AND
- To have signed the informed consent
- AND one of the following conditions:
- Pulmonary MDR/XDR -TB or NTM (difficult to treat or resistant to treatment) confirmed by smear samples and antibiogram or with persistence of positivity for Mycobacterium of the smear after standard pharmacotherapy and severe destruction of the lungs with 1 or more persistent cavities.
- Pulmonary TB or NTM with cavities and associated systemic diseases such as pancreatic diabetes, stomach and duodenum ulcer, liver and kidney diseases, HIV or another such disease that compromises pharmacological treatment.
- Recurrent haemoptysis attributable to TB or NTM
Who cannot join
- Contraindication to performance of bronchoscopy
- Severe cardiac comorbidities
- Severe psychiatric disorders
- Functional or anatomical pneumonectomy
- Asthma
- Pregnancy
Show all 12Show fewer
- Patients for whom bronchoscopic procedures are contraindicated
- Patients with known allergies to Nitinol (nickel-titanium) or its constituent metals (nickel or titanium)
- Patients with known allergies to silicone
- Patients who have not quit smoking
- Patients with large bullae encompassing greater than 30% of either lung
- Patients with active pulmonary infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedaliera Universitaria Careggi
Florence, FI, 50134
Lorenzo Corbetta, +39 055 7947628, lorenzo.corbetta@unifi.it
Valentina Luzzi, valentinaluzzi@hotmail.com; luzziv@aou-careggi.toscana.it
About this study
Official title: Evaluating the Utility of Endobronchial Valves in the Management of Tubercular and NTM (Non Tubercolar Micobacteriosis) Pulmonary Cavities
Tuberculosis (TB) is a complex disease in which the lungs are the primary site of infection. Infection is acquired through inhalation of droplet nuclei laden with Mycobacterium bacilli (M. tuberculosis) that settle in the alveoli as the primary focus. TB is characterized by a gradual expansion of infection and cavitation that causes progressive tissue destruction. Furthermore, the increase in drug-resistant forms of TB, including multidrug resistance (MDR) and pre-extensively drug-resistant TB (XDR), is becoming increasingly concerning. Treatment of pharmacosensitive diseases involves a duration of no less than 6 months, while that of MDR-TB and XDR-TB are even longer; generally well above 24 months. Nontuberculous mycobacteria (NTMs), or atypical mycobacteria, are organisms that cause various diseases such as skin and soft tissue infections, lymphadenitis, lung infections, disseminated infections, and a wide range of more rarely encountered infections that do not differ from tuberculosis in anatomy and radiologically even though they usually do not develop the primary complex. Given that the treatment success rate is unsatisfactory, there is an urgent need for new drugs and additional interventions to improve outcomes, both in patients with MDR/XDR-TB and in patients with difficult-to-treat NTM.
One-way endobronchial valves (EBVs) have been used as an effective lung volume reduction strategy in emphysema without significant adverse events. The mechanism consists in inducing atelectasis, that is, creating a poorly ventilated environment with reduced oxygen tension. This reduced oxygen tension is unfavorable for the survival and proliferation of mycobacteria. Therefore, using these devices to treat cavities caused by multidrug-resistant mycobacteria or in patients not eligible for surgical therapy should reduce or completely heal the cavity, creating an inhospitable environment for the bacteria, slowing or eliminating their growth.
Condition/disease: Pulmonary MDR/XDR-TB or NTM (difficult to treat or resistant to treatment) Number of patients to be enrolled: 30 It is a single-center, randomized, controlled, open-label, two-arm study.
- Being tested
- Endobronchial valves
- Keywords
- Endobronchial valves, Non Tubercolar Micobacteriosis, Multidrug Resistance Tubercolosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial valvesDevice
Also called no interventions
Patients shall undergo a bronchoscopy in sedation using midazolam and/or fentanyl or general anaesthesia with propofol in some cases. For MDR - TB patients the procedure will be done in an isolation room with negative pressure. Rigid bronchoscopy, facial or laryngeal mask airway shall be employed to introduce the fiberoptic bronchoscope, an instrument equipped with an operating channel of variable diameter between 2.8 and 3.2 mm that allows insertion of the valve.
The Zephyr ® EBV is a self-expandable system which is actuated to contact with the bronchial wall, facilitating adhesion to the bronchial wall and moulding in conformity with the bronchial anatomy. Being one-way valves, that prevent the ingress of the air to the segment or lobe under consideration, while allowing, egress of the same during exhalation.
| Study group | Role | What they receive |
|---|---|---|
| Zephyr ® | Experimental | Patients will be randomized in the two arms. All patients will continue antibiotic therapy as per clinical practice. Within 30 days the patients allocated to the experimental arm will be contacted to schedule bronchoscopy for valve placement. The treatment will be performed on a day hospital basis, patients will undergo Chest X-rays before discharge in order to confirm correct valve placement. After 9 month the experimental arm will undergone a procedure in order to remove valves. Receives: Device: Endobronchial valves |
| Control | No intervention | Patients randomized in control arm will continue antibiotic therapy as per clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with cavities reduction equal or above 50% in the two arms
Percentage of patients with cavity dimension, at 9 months of treatment, < or = to 50% of cavity dimension at baseline. The results will be expressed in mm, through the maximum axial diameter. Higher percentage in the experimetal arm Zephyr suggests the efficacy of the treatment.
Measured: At 9 months after the randomization
Percentage of patients with sputum smear negative for microbiological agents in the two arms at 9 months of treatment
The sputum smear for microbiological agents will be collected on a slide and then observed through optical microscopy. The results will be expressed in dichotomous scale. Higher percentage of negative results in the experimental arm Zephyr suggests the efficacy of the treatment.
Measured: 9 months after the randomization
Secondary outcomes (5)
Median of cavity dimension differences at each timepoints in comparison with baseline in both arms.
The difference of cavity assial diameter, expressed in mm, between each timepoints and baseline. Differences will be expressed in median and in interquartile range in each arm.
Measured: At 3 months and 9 months after the randomization
Percentage of patients with sputum smear negative for microbiological agents in the two arms, at each timepoints
The sputum smear for microbiological agents will be collected on a slide and then observed through optical microscopy. The results will be expressed in semiquantitative scale. Higher percentage of negative results in the experimental arm Zephyr suggests the efficacy of the treatment.
Measured: At 1, 3, 9 months after randomization and at 12, 14 months at the follow up
Percentage of culture negative for microbiological agents at each timepoint among the two arms.
At each timepoints sputum will be collected and cultered. The culture will be observed through optical microscopy for 8 weeks. If after 8 weeks no microbacterial growth will be observed, the negativity will be diagnosed for that sample. The results wil be expressed in CFU.
Measured: At 1, 3, 9 months after the randomization and 12, 14 months at the follow up
Percentage of patients with early (within 48 hours) and late complications in the experimental arm Zephyr.
In the experimental arm Zephyr the complications that arise within 48 hours are defined early, events after 48 hours, will be defined late complications. The severity of the complication will be assessed by CTCAE v4.0.
Measured: At T0 (intervention)+48 hours, 3 and 9 months after intervention.
Percentage of patients who have undergone valve reposition in experimental arm Zephyr.
At 3 months after intervention, the correct valve position will be confirmed through CT scan. The results will be expressed as the proportion between patients that undergone for the valve reposition and total patients evaluated at 3 months.
Measured: At 3 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start12 Jan 2026 (estimated)
- Primary completion12 May 2028 (estimated)
- Study completion12 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug Resistance TubercolosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296055
- Sponsor's protocol ID
- 26268_spe
- Other IDs
- 25-01-050896
- Acronym
- TBET
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Utility of Endobronchial Valves in the Management of Tubercular and NTM (Non Tubercolar Micobacteriosis) Pulmonary Cavities
- ClinicalTrials.gov ID
- NCT07296055
- Acronym / sponsor ID
- TBET / 26268_spe
- Keywords
- Endobronchial valves, Non Tubercolar Micobacteriosis, Multidrug Resistance Tubercolosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 12 Jan 2026 (estimated)
- Primary completion
- 12 May 2028 (estimated)
- Study completion
- 12 Dec 2028 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tuberculosis (TB) is a complex disease in which the lungs are the primary site of infection. Infection is acquired through inhalation of droplet nuclei laden with Mycobacterium bacilli (M. tuberculosis) that settle in the alveoli as the primary focus. TB is characterized by a gradual expansion of infection and cavitation that causes progressive tissue destruction. Furthermore, the increase in drug-resistant forms of TB, including multidrug resistance (MDR) and pre-extensively drug-resistant TB (XDR), is becoming increasingly concerning. Treatment of pharmacosensitive diseases involves a duration of no less than 6 months, while that of MDR-TB and XDR-TB are even longer; generally well above 24 months. Nontuberculous mycobacteria (NTMs), or atypical mycobacteria, are organisms that cause various diseases such as skin and soft tissue infections, lymphadenitis, lung infections, disseminated infections, and a wide range of more rarely encountered infections that do not differ from tuberculosis in anatomy and radiologically even though they usually do not develop the primary complex. Given that the treatment success rate is unsatisfactory, there is an urgent need for new drugs and additional interventions to improve outcomes, both in patients with MDR/XDR-TB and in patients with difficult-to-treat NTM.
One-way endobronchial valves (EBVs) have been used as an effective lung volume reduction strategy in emphysema without significant adverse events. The mechanism consists in inducing atelectasis, that is, creating a poorly ventilated environment with reduced oxygen tension. This reduced oxygen tension is unfavorable for the survival and proliferation of mycobacteria. Therefore, using these devices to treat cavities caused by multidrug-resistant mycobacteria or in patients not eligible for surgical therapy should reduce or completely heal the cavity, creating an inhospitable environment for the bacteria, slowing or eliminating their growth.
Condition/disease: Pulmonary MDR/XDR-TB or NTM (difficult to treat or resistant to treatment) Number of patients to be enrolled: 30 It is a single-center, randomized, controlled, open-label, two-arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zephyr ® | Experimental | Device: Endobronchial valvesPatients will be randomized in the two arms. All patients will continue antibiotic therapy as per clinical practice. Within 30 days the patients allocated to the experimental arm will be contacted to schedule bronchoscopy for valve placement. The treatment will be performed on a day hospital basis, patients will undergo Chest X-rays before discharge in order to confirm correct valve placement. After 9 month the experimental arm will undergone a procedure in order to remove valves. |
| Control | No intervention | –Patients randomized in control arm will continue antibiotic therapy as per clinical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 80 years AND
- Patient with cavities deemed unsuitable for surgery (when an extensive pulmonary parenchymal damage due to TB, is present, making patients inappropriate for open thoracic surgery) AND
- To have signed the informed consent
- Pulmonary MDR/XDR -TB or NTM (difficult to treat or resistant to treatment) confirmed by smear samples and antibiogram or with persistence of positivity for Mycobacterium of the smear after standard pharmacotherapy and severe destruction of the lungs with 1 or more persistent cavities.
- Pulmonary TB or NTM with cavities and associated systemic diseases such as pancreatic diabetes, stomach and duodenum ulcer, liver and kidney diseases, HIV or another such disease that compromises pharmacological treatment.
Key exclusion criteria (12 listed)
- Contraindication to performance of bronchoscopy
- Severe cardiac comorbidities
- Severe psychiatric disorders
- Functional or anatomical pneumonectomy
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial valvesAlso: no interventionsPatients shall undergo a bronchoscopy in sedation using midazolam and/or fentanyl or general anaesthesia with propofol in some cases. For MDR - TB patients the procedure will be done in an isolation room with negative pressure. Rigid bronchoscopy, facial or laryngeal mask airway shall be employed to introduce the fiberoptic bronchoscope, an instrument equipped with an operating channel of variable diameter between 2.8 and 3.2 mm that allows insertion of the valve. The Zephyr ® EBV is a self-expandable system which is actuated to contact with the bronchial wall, facilitating adhesion to the bronchial wall and moulding in conformity with the bronchial anatomy. Being one-way valves, that prevent the ingress of the air to the segment or lobe under consideration, while allowing, egress of the same during exhalation. | Device | Zephyr ® |
Primary outcome
Percentage of patients with cavities reduction equal or above 50% in the two arms
Time frame: At 9 months after the randomization
Percentage of patients with cavity dimension, at 9 months of treatment, < or = to 50% of cavity dimension at baseline. The results will be expressed in mm, through the maximum axial diameter. Higher percentage in the experimetal arm Zephyr suggests the efficacy of the treatment.
Percentage of patients with sputum smear negative for microbiological agents in the two arms at 9 months of treatment
Time frame: 9 months after the randomization
The sputum smear for microbiological agents will be collected on a slide and then observed through optical microscopy. The results will be expressed in dichotomous scale. Higher percentage of negative results in the experimental arm Zephyr suggests the efficacy of the treatment.
5 secondary outcomes
Median of cavity dimension differences at each timepoints in comparison with baseline in both arms.
Time frame: At 3 months and 9 months after the randomization
Percentage of patients with sputum smear negative for microbiological agents in the two arms, at each timepoints
Time frame: At 1, 3, 9 months after randomization and at 12, 14 months at the follow up
Percentage of culture negative for microbiological agents at each timepoint among the two arms.
Time frame: At 1, 3, 9 months after the randomization and 12, 14 months at the follow up
Percentage of patients with early (within 48 hours) and late complications in the experimental arm Zephyr.
Time frame: At T0 (intervention)+48 hours, 3 and 9 months after intervention.
Percentage of patients who have undergone valve reposition in experimental arm Zephyr.
Time frame: At 3 months after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial valves in people with Multidrug Resistance Tubercolosis and Non Tubercolar Micobacteriosis, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Corbetta (+39 055 7947628, lorenzo.corbetta@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with cavities reduction equal or above 50% in the two arms (time frame: At 9 months after the randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.