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

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ClinicalTrials.gov Identifier: NCT02096328
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.

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

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Lower Respiratory Infection Drug: POL7080 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016


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




Primary Outcome Measures :
  1. To measure the plasma concentrations of POL7080 [ Time Frame: Day 3 and Day 6 ]
    PK profile of POL7080 will be determined on Day 3 and Day 6.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Daily assessment up to 34 days from informed consent. ]
    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.

  2. Laboratory abnormalities [ Time Frame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 ]
    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.


Other Outcome Measures:
  1. Clinical cure [ Time Frame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 ]
    Clinical cure will be measured based on clinical signs and symptoms and radiological findings.

  2. Reduction in bacterial count [ Time Frame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34 ]
    Reduction in CFU/mL (colony forming unit /mL) of Pseudomonas aeruginosa in the daily quantitative cultures.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096328


Locations
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Greece
ATTIKON University Hospital
Athens, Greece
Hospital EVANGELISMOS
Athens, Greece
Hospital KORGIALENIO-BENAKIO E.E.S
Athens, Greece
SOTIRA Pulmonary Clinic
Athens, Greece
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, Spain
Sponsors and Collaborators
Polyphor Ltd.
Investigators
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Principal Investigator: Antoni Torres, MD PhD Hospital Clinic, Barcelona, SPAIN
Principal Investigator: Evangelos Giamarellos-Bourboulis, MD PhD ATTIKON University Hospital, Athens, GREECE
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Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT02096328    
Other Study ID Numbers: POL7080-003
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: June 2016
Keywords provided by Polyphor Ltd.:
Ventilator Associated Pneumonia (VAP)
Lower respiratory infection
POL7080
Pseudomonas aeruginosa
Nosocomial pneumonia
Additional relevant MeSH terms:
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Infection
Pneumonia, Ventilator-Associated
Respiratory Tract Infections
Pseudomonas Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Cross Infection
Gram-Negative Bacterial Infections
Bacterial Infections
Murepavadin
Anti-Bacterial Agents
Anti-Infective Agents