Ventilator Associated PneumoniaPhase 2NCT02096328
Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia
A Phase 2 study testing POL7080 in people with Ventilator Associated Pneumonia and Lower Respiratory Infection, run by Polyphor Ltd. at 10 sites in 2 countries.
Trial summary
To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during 10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas aeruginosa infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Lower Respiratory Infection
- What is being tested?
- POL7080
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥18 years of age diagnosed with VAP , i.e., pneumonia that arises more than 96 hours after endotracheal intubation documented or suspected to be due to Pseudomonas aeruginosa
- Respiratory specimen suitable for culture and Gram stain collected before starting the treatment
- Written Informed consent from the patient's legally acceptable representative or a relative
Who cannot join
- Patients with known hypersensitivity to fluoroquinolones, carbapenems, cephalosporin, penicillin (beta-lactam antibiotics) or aminoglycoside antibiotics (i.e. all available SoC antibiotics); patients with a clinically significant history of drug allergies and history of anaphylactic reaction and patients with active allergic conditions at the time of screening
- Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics
- Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score >25
- Presence of septic shock at the time of evaluation for study entry
- History of lung transplant
- Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
Show all 9Show fewer
- Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 7 days of study entry
- Patients with impaired renal function
- Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Spain6 sites
Hospital Bellvitge
Barcelona
Hospital Clinic
Barcelona
Hospital Del Mar
Barcelona
Hospital Clinic San Carlos
Madrid
Hospital Joan XXIII
Tarragona
Hospital La Fe
Valencia
Greece4 sites
ATTIKON University Hospital
Athens
Hospital EVANGELISMOS
Athens
Hospital KORGIALENIO-BENAKIO E.E.S
Athens
SOTIRA Pulmonary Clinic
Athens
About this study
Official title: A Phase II, Open-label, Multi-center Study to Assess Pharmacokinetics (PK), Safety and Efficacy of POL7080 Co-administered With Standard of Care (SoC) Treatment in Patients With Ventilator- Associated Pneumonia (VAP) Due to Suspected or Documented Pseudomonas Aeruginosa Infection.
To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during 10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas aeruginosa infection
- Being tested
- POL7080
- Keywords
- Ventilator Associated Pneumonia (VAP), Lower respiratory infection, POL7080, Pseudomonas aeruginosa, Nosocomial pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pseudomonas Infections, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POL7080Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| POL7080, Anti-pseudomonal antibiotics | Experimental | POL7080 daily co-administered with standard of care treatment Receives: Drug: POL7080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the plasma concentrations of POL7080
PK profile of POL7080 will be determined on Day 3 and Day 6.
Measured: Day 3 and Day 6
Secondary outcomes (2)
Adverse Events
Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Death, discontinuations and serious adverse events will be listed and narrative summaries will be provided.
Measured: Daily assessment up to 34 days from informed consent.
Laboratory abnormalities
The number and severity of blood chemistry and hematology abnormal findings will be summarized descriptively and compared to baseline. Clinically significant values/outliers will be listed and commented.
Measured: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyphor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antoni Torres, MD PhD, Principal investigator, Hospital Clinic, Barcelona, SPAINEvangelos Giamarellos-Bourboulis, MD PhD, Principal investigator, ATTIKON University Hospital, Athens, GREECE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096328
- Sponsor's protocol ID
- POL7080-003
- Status last verified
- Jun 2016
- First submitted
- 18 Mar 2014
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Multi-center Study to Assess Pharmacokinetics (PK), Safety and Efficacy of POL7080 Co-administered With Standard of Care (SoC) Treatment in Patients With Ventilator- Associated Pneumonia (VAP) Due to Suspected or Documented Pseudomonas Aeruginosa Infection.
- ClinicalTrials.gov ID
- NCT02096328
- Acronym / sponsor ID
- POL7080-003
- Keywords
- Ventilator Associated Pneumonia (VAP), Lower respiratory infection, POL7080, Pseudomonas aeruginosa, Nosocomial pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Polyphor Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Mar 2014 (estimated)
- 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.
To investigate the pharmacokinetic characteristics of POL7080 co-administered with SoC during 10 to 14 days of treatment in VAP patients due to suspected or documented Pseudomonas aeruginosa infection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POL7080, Anti-pseudomonal antibiotics | Experimental | Drug: POL7080POL7080 daily co-administered with standard of care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients ≥18 years of age diagnosed with VAP , i.e., pneumonia that arises more than 96 hours after endotracheal intubation documented or suspected to be due to Pseudomonas aeruginosa
- Respiratory specimen suitable for culture and Gram stain collected before starting the treatment
- Written Informed consent from the patient's legally acceptable representative or a relative
Key exclusion criteria (9 listed)
- Patients with known hypersensitivity to fluoroquinolones, carbapenems, cephalosporin, penicillin (beta-lactam antibiotics) or aminoglycoside antibiotics (i.e. all available SoC antibiotics); patients with a clinically significant history of drug allergies and history of anaphylactic reaction and patients with active allergic conditions at the time of screening
- Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics
- Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score >25
- Presence of septic shock at the time of evaluation for study entry
- History of lung transplant
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 |
|---|---|---|
| POL7080Intravenous infusion | Drug | POL7080, Anti-pseudomonal antibiotics |
Primary outcome
To measure the plasma concentrations of POL7080
Time frame: Day 3 and Day 6
PK profile of POL7080 will be determined on Day 3 and Day 6.
2 secondary outcomes
Adverse Events
Time frame: Daily assessment up to 34 days from informed consent.
Laboratory abnormalities
Time frame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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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.
Antoni Torres, MD PhD principal investigator
Hospital Clinic, Barcelona, SPAIN
Evangelos Giamarellos-Bourboulis, MD PhD principal investigator
ATTIKON University Hospital, Athens, GREECE
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing POL7080 in people with Ventilator Associated Pneumonia and Lower Respiratory Infection, run by Polyphor Ltd. at 10 sites in 2 countries.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Greece. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the plasma concentrations of POL7080 (time frame: Day 3 and Day 6). 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 28 Nov 2017.