Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia
Information source: Polyphor Ltd.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
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
Summary
To study the blood concentrations of POL7080 in patients who developed pneumonia due to
Pseudomonas aeruginosa following mechanical ventilation.
Clinical Details
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 EventsLaboratory 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.
Eligibility
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
Locations and Contacts
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
Additional Information
Starting date: October 2013
Last updated: March 21, 2014
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