NCT02096328

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 28, 2017

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

March 18, 2014

Last Update Submit

November 24, 2017

Conditions

Ventilator Associated PneumoniaLower Respiratory Infection

Keywords

Ventilator Associated Pneumonia (VAP)Lower respiratory infectionPOL7080Pseudomonas aeruginosaNosocomial pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Adverse Events

    Daily assessment up to 34 days from informed consent.

  • Laboratory abnormalities

    Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34

Other Outcomes (2)

  • Clinical cure

    Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34

  • Reduction in bacterial count

    Day 4, Day 6, Day 10, Day 15, Day 24 and Day 34

Study Arms (1)

POL7080, Anti-pseudomonal antibiotics

EXPERIMENTAL

POL7080 daily co-administered with standard of care treatment

Drug: POL7080

Interventions

POL7080DRUG

Intravenous infusion

POL7080, Anti-pseudomonal antibiotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Respiratory specimen suitable for culture and Gram stain collected before starting the treatment
  • Written Informed consent from the patient's legally acceptable representative or a relative

You may not qualify if:

  • 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
  • Known or suspected pulmonary conditions which are likely to interfere with the therapeutic response or might have additional impact on pharmacokinetics
  • Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score \>25
  • Presence of septic shock at the time of evaluation for study entry
  • History of lung transplant
  • Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count \< 200/mm3
  • Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 7 days of study entry
  • Patients with impaired renal function
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

ATTIKON University Hospital

Athens, Greece

Location

Hospital EVANGELISMOS

Athens, Greece

Location

Hospital KORGIALENIO-BENAKIO E.E.S

Athens, Greece

Location

SOTIRA Pulmonary Clinic

Athens, Greece

Location

Hospital Bellvitge

Barcelona, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital Del Mar

Barcelona, Spain

Location

Hospital Clinic San Carlos

Madrid, Spain

Location

Hospital Joan XXIII

Tarragona, Spain

Location

Hospital La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedPseudomonas InfectionsHealthcare-Associated Pneumonia

Interventions

murepavadin

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Antoni Torres, MD PhD

    Hospital Clinic, Barcelona, SPAIN

    PRINCIPAL INVESTIGATOR

  • Evangelos Giamarellos-Bourboulis, MD PhD

    ATTIKON University Hospital, Athens, GREECE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 26, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

November 28, 2017

Record last verified: 2016-06

Locations

GR(4)ES(6)