An interventional study of Endobronchial valves in Multidrug Resistance Tubercolosis and Non Tubercolar Micobacteriosis, sponsored by Azienda Ospedaliero-Universitaria Careggi. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Treatment
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.
Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 77 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
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The human immunodeficiency virus, which weakens the immune system.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Endobronchial valves
Patients randomized in control arm will continue antibiotic therapy as per clinical practice.
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.
Also known as: no interventions
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.
Time frame: 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.
Time frame: 9 months after the randomization
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.
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
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.
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.
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.
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.
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.
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.
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.
Time frame: At 3 months after the intervention.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for May 2028, 28 months later.
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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