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

Condition(s) targeted: Ventilator Associated Pneumonia; Lower Respiratory Infection

Intervention: POL7080 (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Polyphor Ltd.

Official(s) and/or principal investigator(s):
Antoni Torres, MD PhD, Principal Investigator, Affiliation: Hospital Clinic, Barcelona, SPAIN
Evangelos Giamarellos-Bourboulis, MD PhD, Principal Investigator, Affiliation: ATTIKON University Hospital, Athens, GREECE

Overall contact:
Klaus Dembowsky, MD, Phone: +41 61 567 16 00, Email: Klaus.Dembowsky@polyphor.com

To study the blood concentrations of POL7080 in patients who developed pneumonia due to Pseudomonas aeruginosa following mechanical ventilation.

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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To measure the plasma concentrations of POL7080

Secondary outcome:

Adverse Events

Laboratory abnormalities

Detailed description:

- Patients will be recruited after a written informed consent from the legal

representative or relative.

- Adverse events will be coded using Medical dictionary for Regulatory Activities

(MedDRA).

- Descriptive statistics will be used for the safety and efficacy variables.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 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

Klaus Dembowsky, MD, Phone: +41 61 567 16 00, Email: Klaus.Dembowsky@polyphor.com

ATTIKON University Hospital, Athens, Greece; Recruiting

Hospital EVANGELISMOS, Athens, Greece; Active, not recruiting

Hospital KORGIALENIO-BENAKIO E.E.S, Athens, Greece; Recruiting

SOTIRA Pulmonary Clinic, Athens, Greece; Recruiting

Hospital Bellvitge, Barcelona, Spain; Recruiting

Hospital Clinic, Barcelona, Spain; Recruiting

Hospital Del Mar, Barcelona, Spain; Active, not recruiting

Hospital Clinic San Carlos, Madrid, Spain; Recruiting

Hospital Joan XXIII, Tarragona, Spain; Recruiting

Hospital La Fe, Valencia, Spain; Recruiting

Starting date: October 2013
Last updated: March 21, 2014