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Search / Trial NCT06035055

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

Launched by SUNSHINE COAST HOSPITAL AND HEALTH SERVICE · Sep 6, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called ceftolozane/tazobactam (C/T) to see if it can help patients with bronchiectasis or cystic fibrosis who are experiencing an infection caused by specific bacteria called Pseudomonas aeruginosa or Burkholderia cepacia. The trial aims to find out if this treatment is effective and safe, as well as how the bacteria might become resistant to it over time.

To participate, individuals need to have been diagnosed with cystic fibrosis or bronchiectasis, be currently facing an infection that requires intravenous antibiotics, and be producing sputum (the mucus from the lungs). Unfortunately, those who are pregnant, unable to consent, or have certain medical conditions may not qualify. If eligible, participants can expect to receive the C/T treatment as part of their outpatient care, meaning they can continue their daily activities while receiving the therapy. This study is not yet recruiting participants, but it aims to provide valuable insights into managing these serious infections.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of CF or non-CF bronchiectasis
  • Colonised with P. aeruginosa or BCC species
  • Current infectious exacerbation requiring treatment with intravenous antibiotics
  • Productive of sputum
  • Exclusion Criteria:
  • Unable to consent
  • Active pregnancy (as confirmed by urine beta-HCG)
  • Not appropriate for OPAT (as determined by treating clinician)
  • Estimated Creatinine Clearance \< 50 millilitres/min
  • History of hypersensitivity reaction to piperacillin/tazobactam or members of the cephalosporin class of antibiotics
  • Unable to expectorate

About Sunshine Coast Hospital And Health Service

Sunshine Coast Hospital and Health Service (SCHHS) is a leading healthcare provider in Queensland, Australia, dedicated to delivering high-quality medical care and advancing clinical research. Committed to improving patient outcomes, SCHHS fosters a collaborative environment that integrates innovative research with clinical practice. The organization supports a wide range of clinical trials across various disciplines, aiming to enhance health services and contribute to scientific knowledge. With a focus on patient safety and ethical standards, SCHHS actively engages in partnerships with academic institutions and industry stakeholders to drive advancements in healthcare and ensure the best possible care for the community.

Locations

Patients applied

0 patients applied

Trial Officials

Julia J Bashford, BSc, MBBS

Principal Investigator

Sunshine Coast University Hospital

Andrew Burke, MBBS

Principal Investigator

The Prince Charles Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported