A Randomized, Parallel, Open-Label, Phase 1/2a Study to Assess the Safety and Tolerability of Multiple Doses of the Bacteriophage Cocktail TP-122 (Component TP-122A), for the Treatment of Ventilator-Associated Pneumonia

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.0 个研究点目标入组 15 人开始时间: 2023年11月3日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•1. Subjects able and willing to sign the ICF. If the subject is unable to do so, the family, a trusted person or a relative should provide consent, as per local regulations., 2. Subjects with 18 years old, or older., 3. Subjects with VAP, with stable ventilatory requirements defined as: PaO2/FiO2 not lower than 200 mm Hg; FiO2 = 0.60; Compliance not lower than 30 mL/cm H2O; PEEP equal or lower than 10 cm H2O; If receiving vasoactive drugs, these must be on a stable dose for the last 24 hours., 3.a. At least one of the following: Hypoxemia [e.g., PaO2 < 60 mmHg while the patient is breathing room air, as determined by ABG, or worsening of PaO2/FiO2]; And/or need for acute changes in the ventilator support system to enhance oxygenation, as determined by worsening oxygenation (need to increase FiO2 by 20% or more to maintain oxygen saturation), or needed changes in the amount of PEEP; And/or new onset of suctioned respiratory secretions, 3.b. At least one of the following signs: Documented fever (i.e., core body temperature [tympanic, rectal, esophageal] = 38°C [100.4ºF], oral temperature = 37.5°C [99.5ºF], or axillary temperature = 37°C [98.6ºF]); And/or hypothermia (i.e., core body temperature [tympanic, rectal, esophageal] = 35°C [95°F]); And/or WBC count = 10,000 cells/mm³; And/or leukopenia with total WBC count = 4500 cells/mm³; And/or v. Greater than 15% immature neutrophils (bands) noted on peripheral blood smear., 4. Microbiological diagnosis of P. aeruginosa infection in the LRT, before randomization. Diagnosis: cultures obtained by ETA, mini BAL or standard BAL throughout fiberoptic bronchoscopy, subjected to Gram staining and/or PCR test (e.g. BIOFIRE® FILMARRAY® Pneumonia Panel plus (Biomerieux))., 5. Female subjects of childbearing potential must have a negative highly sensitive pregnancy test at screening., 6. Subject registered into a social security scheme

排除标准

•History of any cancer requiring systemic chemotherapy or radiation, in the 5 previous years., Subjects with pleural effusions (or empyema) requiring therapeutic drainage, or lung abscess, or bronchiectasis; or cystic fibrosis, or acute exacerbation of chronic bronchitis, or active pulmonary tuberculosis; or with stage IV congestive heart failure, or cirrhotic liver disease., Individuals deprived of liberty or placed under the authority of a tutor, Subjects with severe asthma or reactive airway disease, A condition that, in the opinion of the Investigator, could compromise the well-being of the subject, or the course of the study, or prevent the subject from meeting/performing any study requirements/procedures., Immunocompromised subjects due to illness, or organ transplant, or immunosuppressive therapies (e.g., oral or parenteral corticosteroids, methotrexate, immune modulators), in the last 3 months prior to screening., Treatment with ad hoc low dose inhaled corticosteroids, in the last 2 weeks prior to randomization (except hydrocortisone and equivalent doses of prednisone and methylprednisolone)., Being pregnant or breastfeeding, Currently participating in another clinical trial or having participated in a clinical trial with receipt of an investigational product in the last 30 days prior to randomization or in the last ‘5 half-lives of the investigational product’ prior to randomization (whichever is longer)., Subjects with known community-acquired bacterial pneumonia, or viral or fungal (including Pneumocystis jiroveci) pneumonia (except for subjects that had SARS-CoV-2 related pneumonia more than 6 months before randomization, that do not require long-term oxygen therapy (LTOT)), or tracheobronchitis (without documented pneumonia), or chemical pneumonitis, or post-obstructive pneumonia (except for subjects with a mild severity disease, that do not require pulmonary function tests); or tracheostomy (except for subjects that have tracheostomy performed while being hospitalised in the ICU)., Subjects requiring Airway Pressure Release Ventilation or High Frequency Oscillatory Ventilation.

研究者

发起方

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

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