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

Primary Purpose

Ventilator Associated Pneumonia, Lower Respiratory Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
POL7080
Sponsored by
Polyphor Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Associated Pneumonia focused on measuring Ventilator Associated Pneumonia (VAP), Lower respiratory infection, POL7080, Pseudomonas aeruginosa, Nosocomial pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Informed consent from the patient's legally acceptable representative or a relative

Exclusion Criteria:

  1. 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
  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 HIV 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 investigational device or drug trial or are receiving other investigational agent

Sites / Locations

  • ATTIKON University Hospital
  • Hospital EVANGELISMOS
  • Hospital KORGIALENIO-BENAKIO E.E.S
  • SOTIRA Pulmonary Clinic
  • Hospital Bellvitge
  • Hospital Clinic
  • Hospital Del Mar
  • Hospital Clinic San Carlos
  • Hospital Joan XXIII
  • Hospital La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

POL7080, Anti-pseudomonal antibiotics

Arm Description

POL7080 daily co-administered with standard of care treatment

Outcomes

Primary Outcome Measures

To measure the plasma concentrations of POL7080
PK profile of POL7080 will be determined on Day 3 and Day 6.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 18, 2014
Last Updated
November 24, 2017
Sponsor
Polyphor Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02096328
Brief Title
Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polyphor Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia, Lower Respiratory Infection
Keywords
Ventilator Associated Pneumonia (VAP), Lower respiratory infection, POL7080, Pseudomonas aeruginosa, Nosocomial pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POL7080, Anti-pseudomonal antibiotics
Arm Type
Experimental
Arm Description
POL7080 daily co-administered with standard of care treatment
Intervention Type
Drug
Intervention Name(s)
POL7080
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
To measure the plasma concentrations of POL7080
Description
PK profile of POL7080 will be determined on Day 3 and Day 6.
Time Frame
Day 3 and Day 6
Secondary Outcome Measure Information:
Title
Adverse Events
Description
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.
Title
Laboratory abnormalities
Description
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 Pre-specified Outcome Measures:
Title
Clinical cure
Description
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
Title
Reduction in bacterial count
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Torres, MD PhD
Organizational Affiliation
Hospital Clinic, Barcelona, SPAIN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evangelos Giamarellos-Bourboulis, MD PhD
Organizational Affiliation
ATTIKON University Hospital, Athens, GREECE
Official's Role
Principal Investigator
Facility Information:
Facility Name
ATTIKON University Hospital
City
Athens
Country
Greece
Facility Name
Hospital EVANGELISMOS
City
Athens
Country
Greece
Facility Name
Hospital KORGIALENIO-BENAKIO E.E.S
City
Athens
Country
Greece
Facility Name
SOTIRA Pulmonary Clinic
City
Athens
Country
Greece
Facility Name
Hospital Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Clinic San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

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

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