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Clinical trial to assess the safety and tolerability of TP-122A for the treatment of ventilator-associated pneumonia.
EU CTIS ID: 2023-508825-29-00
What this study is testing
The primary objective of this study is to evaluate the safety and tolerability following nebulization of multiple doses of TP-122A, every 8 hours, for 7 days, in addition to SoC, in adult subjects with VAP
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)).
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.