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CompletedNCT02096328Updated Nov 28, 2017

Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia

A Phase 2 interventional study of POL7080 in Ventilator Associated Pneumonia and Lower Respiratory Infection, sponsored by Polyphor Ltd.. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Polyphor Ltd. · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 25 studies in Pneumonia, Ventilator-Associated with a site in Spain — 4 open to participants now, 5 under way, none of them phase 3. Pneumonia, Ventilator-Associated · Spain.

Enrollment
19th of 21
25 · median 152
Started
2013
with 1 other
Phase 2
4 of 25
none open now
Registered
11th of 25
by date

Among the 25 studies in Pneumonia, Ventilator-Associated with a site in Spain, this one is the 19th largest by enrollment of the 21 interventional ones that give a count, is one of 2 that started in 2013, is one of 4 in phase 2, and was the 11th registered.

Pneumonia, Ventilator-Associated

420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 83 are open to participants now.

Browse Pneumonia, Ventilator-Associated studies →

Open to participants now

4 of the 25 studies in Pneumonia, Ventilator-Associated with a site in Spain are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 47 Pneumonia, Ventilator-Associated studies recruiting now, 36 (77%) set no upper age limit and 6 (13%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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

03

Conditions studied

  • Ventilator Associated Pneumonia
  • Lower Respiratory Infection

Keywords

  • Ventilator Associated Pneumonia (VAP)
  • Lower respiratory infection
  • POL7080
  • Pseudomonas aeruginosa
  • Nosocomial pneumonia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Respiratory specimen suitable for culture and Gram stain collected before starting the treatment
  3. Written from the patient's legally acceptable representative or a relative

Exclusion criteria

Exclusion Criteria:

  1. Patients with known to fluoroquinolones, carbapenems, cephalosporin, penicillin (beta-lactam antibiotics) or aminoglycoside antibiotics (i.e. all available SoC antibiotics); patients with a history of drug allergies and history of anaphylactic reaction and patients with active allergic conditions at the time of screening
  2. Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics
  3. Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score >25
  4. Presence of septic shock at the time of evaluation for study entry
  5. History of lung transplant
  6. Patients with known infection with CD4+ (cluster of differentiation 4) cell count \< 200/mm3
  7. Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 7 days of study entry
  8. Patients with impaired renal function
  9. Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another device or drug trial or are receiving other investigational agent
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    POL7080, Anti-pseudomonal antibiotics

    POL7080 daily co-administered with standard of care treatment

    Drug: POL7080

Interventions

06

What researchers measure

Primary outcomes

  1. To measure the plasma concentrations of POL7080

    PK profile of POL7080 will be determined on Day 3 and Day 6.

    Time frame: Day 3 and Day 6

Secondary outcomes

  1. 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.

    Time frame: Daily assessment up to 34 days from informed consent.

  2. 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.

    Time frame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34

Other outcomes

  1. Clinical cure

    Clinical cure will be measured based on clinical signs and symptoms and radiological findings.

    Time frame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34

  2. Reduction in bacterial count

    Reduction in CFU/mL (colony forming unit /mL) of Pseudomonas aeruginosa in the daily quantitative cultures.

    Time frame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34

07

Study locations

10 sites
  • ATTIKON University Hospital
    Athens, Greece
  • Hospital EVANGELISMOS
    Athens, Greece
  • Hospital KORGIALENIO-BENAKIO E.E.S
    Athens, Greece
  • SOTIRA Pulmonary Clinic
    Athens, Greece
  • Hospital Bellvitge
    Barcelona, Spain
  • Hospital Clinic
    Barcelona, Spain
  • Hospital Del Mar
    Barcelona, Spain
  • Hospital Clinic San Carlos
    Madrid, Spain
  • Hospital Joan XXIII
    Tarragona, Spain
  • Hospital La Fe
    Valencia, Spain
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2013, a primary completion of Dec 2015 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2014
First posted
Mar 26, 2014
Start
Oct 2013
Primary completionActual
Dec 2015
CompletionActual
Dec 2016
Last update
Nov 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02096328
Lead sponsor
Polyphor Ltd.
Responsible party
Sponsor
First posted
Mar 26, 2014
Start date
Oct 2013
Primary completion
Dec 2015
Completion
Dec 2016
Last update
Nov 28, 2017

Study contacts

Antoni Torres, MD PhD
principal investigator · Hospital Clinic, Barcelona, SPAIN
Evangelos Giamarellos-Bourboulis, MD PhD
principal investigator · ATTIKON University Hospital, Athens, GREECE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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