NCT03510351

Brief Summary

This study will describe clinical outcomes in patients who received ceftolozane-tazobactam for a Pseudomonas aeruginosa infection. Primary outcomes include 30-day and in-hospital mortality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

November 27, 2017

Last Update Submit

April 17, 2018

Conditions

Pseudomonas InfectionsPseudomonas Aeruginosa

Outcome Measures

Primary Outcomes (1)

  • Mortality

    30-day mortality

    30 days

Secondary Outcomes (1)

  • Microbiological cure

    Up to 12 weeks

Study Arms (1)

Treated subjects

All patients with Pseudomonas infections treated with ceftolozane-taezobactam who meet the inclusion criteria

Drug: Ceftolozane-Tazobactam

Interventions

Ceftolozane-TazobactamDRUG

Subjects treated with ceftolozane-tazobactam for Pseudomonas infections

Treated subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had Pseudomonas aeruginosa infection and received ceftolozane-tazobactam for at least 24 hrs for treatment.

You may qualify if:

  • Greater than 18 years old
  • Cultures positive Pseudomonas aeruginosa from any source
  • Received ceftolozane-tazobactam for at least 24 hrs

You may not qualify if:

  • Protected populations
  • Prisoners, pregnant women, children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University, School of Pharmacy

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Pseudomonas Infections

Interventions

ceftolozane, tazobactam drug combination

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Peter Doukas, Ph.D

    Temple University - School of Pharmacy

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

April 27, 2018

Study Start

February 1, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

April 27, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)