Pneumonia, Ventilator-AssociatedPhase 1/2RECOVERNCT06370598
Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia
A Phase 1/2 study testing TP-122A in people with Pneumonia, Ventilator-Associated, run by Technophage, SA at 1 site in France.
Trial summary
Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- TP-122A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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;
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- Positive End-Expiratory Pressure (PEEP) equal or lower than 10 cm H2O;
- If receiving vasoactive drugs, these must be on a stable dose for the last 24 hours.
- AND at least one of the following:
- Hypoxemia [e.g., PaO2<60 mmHg while the patient is breathing room air, as determined by Arterial Blood Gas (ABG), or worsening of PaO2/FiO2]; and/or ii. 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 iii. New onset of suctioned respiratory secretions.
- AND 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 v. Hypothermia (i.e., core body temperature [tympanic, rectal, esophageal] ≤ 35°C [95°F]); and/or vi. White Blood Cell (WBC) count ≥ 10,000 cells/mm³; and/or vii. Leukopenia with total WBC count ≤ 4500 cells/mm³; and/or viii. 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 Endotracheal Aspirates (ETA), Mini Bronchoalveolar Lavage (BAL) or standard BAL throughout fiberoptic bronchoscopy, subjected to Gram staining and/or Polymerase Chain Reaction (PCR) test (e.g., BIOFIRE® FILMARRAY® Pneumonia Panel plus (Biomerieux)).
- 5. Subjects with childbearing potential must have a negative highly sensitive serum pregnancy test at screening.
Who cannot join
- 1. History of any cancer requiring systemic chemotherapy or radiation, in the 5 previous years.
- 2. 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.
- 3. Immunocompromised subjects due to illness, organ transplant, or immunosuppressive therapies (e.g., oral or parenteral corticosteroids, methotrexate, immunomodulators), in the last 3 months prior to screening.
- 4. 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).
- 5. Being pregnant or breastfeeding. 6. Currently participating in another clinical trial or having participated in a clinical trial with receipt of an IP in the last 30 days prior to randomization or in the last '5 half-lives of the IP' prior to randomization (whichever is longer).
- 7. 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).
- 8. Subjects requiring Airway Pressure Release Ventilation or High Frequency Oscillatory Ventilation.
- 9. 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone.
Read the detailed description
This is a randomized, parallel, open label, Phase 1/2a study, to assess the safety and tolerability of multiple doses of the component A of the bacteriophage cocktail TP-122 (TP-122A) administered by nebulization in addition to SoC, compared to SoC alone, in adult subjects with VAP. SoC being defined as the treatment dispensed in ICU by the medical team in their usual manner, which will include antibiotic treatment according to current guidelines.
Enrolled subjects randomized to TP-122A arm will receive 5 ml of IP by nebulization, every 8 hours, during 7 days, and will be followed-up for 28 days after the last IP administration.
TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . B This study will exclusively focus on assessing the safety and effectiveness of component A, TP-122A, specifically targeting infections caused by P. aeruginosa. The IP, TP-122A, will be administered by nebulization at 1x1010 Plaque Forming Units (PFU)/ml every 8h during 7 days, in addition to SoC, for the treatment of adult subjects with VAP due to P. aeruginosa. The decision to go for a frequency of administration of every 8 hours was firstly based on preclinical studies. TP-122A is composed of three lytic bacteriophages targeting P. aeruginosa.
An estimated total of 15 evaluable subjects are expected to complete the study. "Evaluable patients" will be considered subjects that have received at least a total of 9 IP administrations for three consecutive days.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- TP-122A
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-122ABiological
Bacteriophage cocktail targeting Psa
| Study group | Role | What they receive |
|---|---|---|
| TP-122A with SOC | Experimental | Enrolled subjects in the TP-122A+SoC arm will receive IP every 8 hours for 7 days by nebulization and will be followed-up for 28 days after the last IP administration. Receives: Biological: TP-122A |
| SOC alone | No intervention | Just standard of care will be given to patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and tolerability following nebulization of multiple doses of TP-122A
Analysis of TP-122A arm with SoC versus SoC alone, and individual analysis per treatment arm of the following assessments:
Adverse Events (AEs):
- Incidence of Treatment-Emergent Adverse Events (TEAEs).
- Incidence of serious TEAEs. Note: including assessment of seriousness, severity, causality, and outcome.
Measured: Day 0, 3 and Day 7
Secondary outcomes (4)
Proportion of subjects achieving "Clinical Cure" CR
Measured: dosing days (1 to 7) and FUp1).
Time to achieve "Clinical Cure" CR
Measured: Baseline to EOT
Proportion of subjects achieving "Eradication" or "Presumed Eradication" MR of TP-122A target bacteria
Measured: dosing days (1 to 7), FUp1 and FUp2
Time to achieve "Eradication" or "Presumed Eradication" MR
Measured: Day o and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technophage, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VectorB2B
- Responsible party
- Sponsor
- Investigators
- Margarida Barreto, Msc, Study director, Technophage, SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370598
- Sponsor's protocol ID
- TP-122
- Acronym
- RECOVER
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06370598
- Acronym / sponsor ID
- RECOVER / TP-122
- Conditions
- Pneumonia, Ventilator-Associated
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Technophage, SAIndustry (pharma, biotech, devices)
- Collaborators
- VectorB2B
- Study start
- Sep 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone.
Detailed description
This is a randomized, parallel, open label, Phase 1/2a study, to assess the safety and tolerability of multiple doses of the component A of the bacteriophage cocktail TP-122 (TP-122A) administered by nebulization in addition to SoC, compared to SoC alone, in adult subjects with VAP. SoC being defined as the treatment dispensed in ICU by the medical team in their usual manner, which will include antibiotic treatment according to current guidelines.
Enrolled subjects randomized to TP-122A arm will receive 5 ml of IP by nebulization, every 8 hours, during 7 days, and will be followed-up for 28 days after the last IP administration.
TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . B This study will exclusively focus on assessing the safety and effectiveness of component A, TP-122A, specifically targeting infections caused by P. aeruginosa. The IP, TP-122A, will be administered by nebulization at 1x1010 Plaque Forming Units (PFU)/ml every 8h during 7 days, in addition to SoC, for the treatment of adult subjects with VAP due to P. aeruginosa. The decision to go for a frequency of administration of every 8 hours was firstly based on preclinical studies. TP-122A is composed of three lytic bacteriophages targeting P. aeruginosa.
An estimated total of 15 evaluable subjects are expected to complete the study. "Evaluable patients" will be considered subjects that have received at least a total of 9 IP administrations for three consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TP-122A with SOC | Experimental | Biological: TP-122AEnrolled subjects in the TP-122A+SoC arm will receive IP every 8 hours for 7 days by nebulization and will be followed-up for 28 days after the last IP administration. |
| SOC alone | No intervention | –Just standard of care will be given to patient |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. 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.
- PaO2/FiO2 not lower than 200 mm Hg;
- FiO2 ≤ 0.60
- Compliance not lower than 30 mL/cm H2O;
Key exclusion criteria (8 listed)
- 2. 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.
- 3. Immunocompromised subjects due to illness, organ transplant, or immunosuppressive therapies (e.g., oral or parenteral corticosteroids, methotrexate, immunomodulators), in the last 3 months prior to screening.
- 4. 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).
- 5. Being pregnant or breastfeeding. 6. Currently participating in another clinical trial or having participated in a clinical trial with receipt of an IP in the last 30 days prior to randomization or in the last '5 half-lives of the IP' prior to randomization (whichever is longer).
- 7. 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TP-122ABacteriophage cocktail targeting Psa | Biological | TP-122A with SOC |
Primary outcome
Evaluate safety and tolerability following nebulization of multiple doses of TP-122A
Time frame: Day 0, 3 and Day 7
Analysis of TP-122A arm with SoC versus SoC alone, and individual analysis per treatment arm of the following assessments: Adverse Events (AEs): 1. Incidence of Treatment-Emergent Adverse Events (TEAEs). 2. Incidence of serious TEAEs. Note: including assessment of seriousness, severity, causality, and outcome.
4 secondary outcomes
Proportion of subjects achieving "Clinical Cure" CR
Time frame: dosing days (1 to 7) and FUp1).
Time to achieve "Clinical Cure" CR
Time frame: Baseline to EOT
Proportion of subjects achieving "Eradication" or "Presumed Eradication" MR of TP-122A target bacteria
Time frame: dosing days (1 to 7), FUp1 and FUp2
Time to achieve "Eradication" or "Presumed Eradication" MR
Time frame: Day o and Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarida Barreto, Msc study director
Technophage, SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TP-122A in people with Pneumonia, Ventilator-Associated, run by Technophage, SA at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margarida Barreto, Msc (+351215943993, mbarreto@technophage.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety and tolerability following nebulization of multiple doses of TP-122A (time frame: Day 0, 3 and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.