Endobronchial Valve in Tubercular and NTM Pulmonary Cavities.

Официальное название

Evaluating the Utility of Endobronchial Valves in the Management of Tubercular and NTM (Non Tubercolar Micobacteriosis) Pulmonary Cavities

Обзор

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.

Вмешательства

• Устройство Endobronchial valves
  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-exp

Первичные конечные точки

• Percentage of patients with cavities reduction equal or above 50% in the two arms [Срок оценки: 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 [Срок оценки: 9 months after the randomization]

Вторичные конечные точки (5)

• Median of cavity dimension differences at each timepoints in comparison with baseline in both arms. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: At T0 (intervention)+48 hours, 3 and 9 months after intervention.]
• Percentage of patients who have undergone valve reposition in experimental arm Zephyr. [Срок оценки: At 3 months after the intervention.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Contraindication to performance of bronchoscopy
• Severe cardiac comorbidities
• Severe psychiatric disorders
• Functional or anatomical pneumonectomy
• Asthma
• Pregnancy
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Azienda Ospedaliera Universitaria Careggi — Florence

Идентификаторы

NCT: NCT07296055 · 26268_spe · 25-01-050896

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗