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Ceftolozane/Tazobactam Continuous Infusion for Infective Exacerbations of Cystic Fibrosis and Bronchiectasis

NCT06035055 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-13

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the feasibility of ceftolozane/tazobactam (C/T) administered on an outpatient parenteral antibiotic therapy programme to patients with a current infective exacerbation of bronchiectasis or cystic fibrosis related to pseudomonas aeruginosa or burkholderia cepacia spp. organisms. The main question\[s\] it aims to answer are:

* Is C/T effective, safe, well-tolerated and able to induce clinical and microbiologic response?
* What are mechanisms of antimicrobial resistance are induced by administration of C/T?

Conditions

Interventions

DRUG

Ceftolozane/tazobactam

9g ceftolozane/tazobactam in 240 millilitres 0.9% sodium chloride IV infusion given over 24 hours for 10-14 days

Sponsors & Collaborators

  • The Prince Charles Hospital

    collaborator OTHER_GOV

  • Mater

    collaborator OTHER

  • Sunshine Coast Hospital and Health Service

    lead OTHER

Principal Investigators

  • Julia J Bashford, BSc, MBBS · Sunshine Coast University Hospital

  • Andrew Burke, MBBS · The Prince Charles Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-10-31
Completion
2024-01-31
FDA Drug
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06035055 on ClinicalTrials.gov