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

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

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia; Lower Respiratory Infection
• Intervention / Treatment: Drug: POL7080

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POL7080, Anti-pseudomonal antibiotics; POL7080 daily co-administered with standard of care treatment	Drug: POL7080; Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the plasma concentrations of POL7080	PK profile of POL7080 will be determined on Day 3 and Day 6.	Day 3 and Day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure	Clinical cure will be measured based on clinical signs and symptoms and radiological findings.	Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34
Reduction in bacterial count	Reduction in CFU/mL (colony forming unit /mL) of Pseudomonas aeruginosa in the daily quantitative cultures.	Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34

Collaborators and Investigators

• Sponsor: Polyphor Ltd.
• Investigators: Principal Investigator: Antoni Torres, MD PhD, Hospital CLinic, Barcelona, Spain; Principal Investigator: Evangelos Giamarellos-Bourboulis, MD PhD, Attikon University Hospital, Athens, Greece

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 24, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Pseudomonas aeruginosa; Nosocomial pneumonia; Ventilator Associated Pneumonia (VAP); POL7080; Lower respiratory infection
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Infections; Pneumonia; Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Pseudomonas Infections; Anti-Infective Agents; Anti-Bacterial Agents; Murepavadin
• Other Study ID Numbers: POL7080-003