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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Unidade Local De Saude De Loures-Odivelas EPE Loures Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Anjfkojom Ubh Amsterdam The Netherlands
Gywl Sgnty Puyztnuzi Cxtcpnk Szbt Cascais Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Not yet recruiting
02.03.2026
The Netherlands The Netherlands
Not yet recruiting
02.03.2026

Trial locations

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.

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 ID:
2025-521533-85-00
Protocol code:
TP-122_101A
NCT ID:
NCT06370598
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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