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

NCT ID: NCT02096328

Last Updated: 2017-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-12-31

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

Conditions

Ventilator Associated Pneumonia; Lower Respiratory Infection

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

POL7080, Anti-pseudomonal antibiotics

POL7080 daily co-administered with standard of care treatment

Group Type: EXPERIMENTAL

POL7080

Intervention Type: DRUG

Intravenous infusion

Interventions

POL7080

Intravenous infusion

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polyphor Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoni Torres, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic, Barcelona, SPAIN

Evangelos Giamarellos-Bourboulis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

ATTIKON University Hospital, Athens, GREECE

Locations

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

Countries

Greece; Spain

Other Identifiers

POL7080-003

Identifier Type: -

Identifier Source: org_study_id