NCT02096315

Brief Summary

To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2013

Geographic Reach
2 countries

4 active sites

Status
terminated

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

December 1, 2013

Completed
4 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
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 1, 2017

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

March 18, 2014

Last Update Submit

January 31, 2017

Conditions

BronchiectasisLower Respiratory Infection

Keywords

POL7080Pseudomonas aeruginosaNon cystic fibrosis bronchiectasisExacerbation

Outcome Measures

Primary Outcomes (1)

  • Sputum bacterial clearance

    Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa

    Day 4, Day 5, Day 10, Day 15 and Day 20

Secondary Outcomes (3)

  • Adverse events

    Daily assessment up to 20 days from informed consent.

  • Laboratory abnormalities.

    Day 4, Day 10, Day 15 and Day 20

  • Volume of sputum in 24 hours

    Day 4, Day 10, Day 15 and Day 20

Other Outcomes (1)

  • To measure the plasma concentrations of POL7080

    Day 3

Study Arms (1)

POL7080

EXPERIMENTAL

POL7080 administered daily

Drug: POL7080

Interventions

POL7080DRUG

Intravenous infusion

POL7080

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female aged ≥18 to \<80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection
  • Sputum sample collected for culture before starting treatment

You may not qualify if:

  • Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception
  • Subjects suffering from cystic fibrosis, active pulmonary mycobacterial infection, end stage chronic obstructive pulmonary disease on long term oxygen therapy, severe uncontrolled asthma, active sarcoidosis and active allergic broncho-pulmonary aspergillosis
  • Current exacerbation of bronchiectasis is associated with lung abscess or empyema
  • Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa
  • Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count \< 200/mm3
  • 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 (4)

Hospital Bellvitge

Barcelona, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Royal Infirmary

City of Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

BronchiectasisPseudomonas Infections

Interventions

murepavadin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Eva Polverino, MD

    Hospital Clinic, Barcelona, SPAIN

    PRINCIPAL INVESTIGATOR

  • Adam Hill, MD PhD

    Royal Infirmary, Edinburgh, U.K.

    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

December 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 1, 2017

Record last verified: 2015-11

Locations

GB(1)ES(3)