Clinical trial NCT02096328: Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ventilator Associated Pneumonia
Lower Respiratory Infection
Keywords: Ventilator Associated Pneumonia (VAP)
Lower respiratory infection
POL7080
Pseudomonas aeruginosa
Nosocomial pneumonia
Lead sponsor: Polyphor Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To measure the plasma concentrations of POL7080
timeFrame: Day 3 and Day 6
Secondary outcomes:
measure: Adverse Events
timeFrame: Daily assessment up to 34 days from informed consent.
measure: Laboratory abnormalities
timeFrame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34
Other outcomes:
measure: Clinical cure
timeFrame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34
measure: Reduction in bacterial count
timeFrame: Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34
Locations:
city: Athens
country: Greece
facility: ATTIKON University Hospital
city: Athens
country: Greece
facility: Hospital EVANGELISMOS
city: Athens
country: Greece
facility: Hospital KORGIALENIO-BENAKIO E.E.S
city: Athens
country: Greece
facility: SOTIRA Pulmonary Clinic
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Madrid
country: Spain
facility: Hospital Clinic San Carlos
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Hospital Clinic, Barcelona, SPAIN
name: Antoni Torres, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ATTIKON University Hospital, Athens, GREECE
name: Evangelos Giamarellos-Bourboulis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: