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

Ventilator Associated Pneumonia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096328
• Other study ID #: POL7080-003
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2014
• Last updated: November 24, 2017
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Polyphor Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Lower Respiratory Infection
• Pneumonia
• Pneumonia, Ventilator-Associated
• Pseudomonas Infections
• Respiratory Tract Infections
• Ventilator Associated Pneumonia

Intervention

Drug:
• POL7080
Intravenous infusion

Locations

Country	Name	City	State
Greece	ATTIKON University Hospital	Athens
Greece	Hospital EVANGELISMOS	Athens
Greece	Hospital KORGIALENIO-BENAKIO E.E.S	Athens
Greece	SOTIRA Pulmonary Clinic	Athens
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Polyphor Ltd.

Countries where clinical trial is conducted

Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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.
Secondary	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