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Safety and tolerability study of bacteriophage cocktail TP-122A given by inhalation in adults with ventilator-associated pneumonia

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on treating Ventilator-Associated Pneumonia, a lung infection that develops in patients who are on mechanical breathing support. The investigational treatment being tested is called TP-122, which is a special mixture of bacteriophages (naturally occurring viruses that target specific bacteria) designed to fight against harmful bacteria like Pseudomonas aeruginosa and Klebsiella pneumoniae.

The purpose of this research is to evaluate how safe and well-tolerated TP-122 is when given through a nebulizer (a device that turns medicine into a fine mist for breathing) every 8 hours for 7 days. The treatment will be given alongside standard medical care to adults who are on breathing machines in intensive care units.

During the study, participants will receive either the new treatment plus standard care or standard care alone. The research team will monitor patients' health through various medical tests, including blood work, vital signs, and heart measurements. They will also track how well patients recover from their infection and how long they need to stay in intensive care.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be assessed based on specific medical criteria, including being 18 years or older and receiving mechanical ventilation in intensive care for at least 48 hours

    A chest X-ray or CT scan will be performed to confirm presence of pneumonia-related changes

    Laboratory tests will be conducted to check white blood cell count and confirm P. aeruginosa infection in respiratory tract

    If applicable, a pregnancy test will be performed

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either:

    Standard care plus TP-122A treatment through nebulization (inhaled medication), or

    Standard care alone

  3. Step 3

    Treatment period

    Treatment duration is 7 days

    If assigned to the TP-122A group, you will receive the medication through nebulization every 8 hours

    Regular monitoring of vital signs will be conducted

    Blood tests will be performed to check laboratory parameters

    Heart activity will be monitored through ECG (heart electrical activity test)

    Any side effects will be recorded

  4. Step 4

    Monitoring period

    Your response to treatment will be evaluated

    Time spent on mechanical ventilation will be recorded

    Duration of intensive care stay will be monitored

    Antibiotic usage will be tracked

    Additional follow-up evaluations will be conducted to assess overall recovery

Who can join the trial?

8 criteria

  • Must be able to sign the informed consent form, or have a legal representative who can provide consent in emergency situations
  • Must be 18 years of age or older
  • Must be in intensive care unit on a breathing machine (ventilator) for at least 48 hours with: - Adequate oxygen levels in blood - Specific oxygen requirements - Proper lung function - Specific ventilator pressure settings
  • Must not have been diagnosed with new pneumonia within the last 72 hours before study entry
  • Must have new signs of lung infection visible on chest X-ray or CT scan within the last 24 hours
  • Must show new breathing problems with either: - Need for increased oxygen support, OR - At least two of these signs: - Fever (high body temperature) - Very low body temperature - High white blood cell count - Low white blood cell count - New mucus production from breathing tube - Physical signs of lung infection during examination
  • Must have confirmed Pseudomonas aeruginosa (type of bacteria) infection in the lungs through laboratory testing
  • If able to become pregnant, must have a negative pregnancy test during screening

Who cannot join the trial?

15 criteria

  • Known allergy or hypersensitivity to any of the study medication components
  • Active lung disease other than Ventilator-Associated Pneumonia (VAP), such as severe asthma or chronic obstructive pulmonary disease
  • Severe kidney problems (impaired renal function)
  • Severe liver problems (impaired liver function)
  • Participation in another clinical trial within the last 30 days
  • History of severe allergic reactions to medications
  • Pregnancy or breastfeeding
  • Life-threatening conditions unrelated to VAP
  • Unable to provide informed consent (either directly or through a legal representative)
  • Major surgery planned during the study period
  • Significant abnormalities in blood tests that could affect study results
  • Use of medications that could interfere with the study treatment
  • History of organ transplantation
  • Active cancer requiring treatment
  • Severe heart conditions that could affect breathing
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Investigated drugs

Based on the provided trial information: TP-122A This is a bacteriophage cocktail (a mixture of viruses that target bacteria) that is administered through nebulization (converted into a fine mist for inhalation). It is being studied as an additional treatment alongside standard care for patients with ventilator-associated pneumonia. Bacteriophages are viruses that specifically target and kill bacteria, offering a potential alternative or complement to traditional antibiotics. Standard of Care (SoC) This refers to the current best-practice treatments that patients typically receive for ventilator-associated pneumonia. This usually includes antibiotics and other supportive care measures. In this trial, it is being used in combination with the experimental TP-122A treatment.

What is already known about the treatment

TP-122A - A therapeutic bacteriophage cocktail administered through nebulization (inhalation) for treating Ventilator-Associated Pneumonia (VAP) in adult patients. This experimental treatment is currently undergoing Phase 1/2a clinical trials to evaluate its safety and tolerability when given every 8 hours for 7 days alongside standard medical care. The medication represents an innovative approach using viruses that specifically target harmful bacteria, offering a potential alternative or complement to conventional antibiotics in treating respiratory infections in ventilated patients. As a bacteriophage-based therapy, it works by directly attacking and destroying specific bacterial pathogens in the lungs while leaving healthy cells unaffected.

Investigated diseases

Ventilator-Associated Pneumonia – A type of lung infection that develops in people who are on mechanical ventilation breathing machines in hospitals. The condition typically occurs 48 hours or more after a patient has been intubated. The infection develops because the tube used in mechanical ventilation can allow bacteria to enter the lungs. During ventilation, bacteria can grow in the tube and travel into the lungs, causing an infection. The condition leads to inflammation of the lung tissue and accumulation of fluid in the air sacs. Symptoms typically include changes in the color and amount of mucus from the airways, fever, and worsening oxygenation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-521533-85-00Protocol codeTP-122_101AEstimated enrolment38 patientsSponsorTechnophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).