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

NCT06035055 | Unknown Phase 4 DMC FDA Drug

• 2 other identifiers: U1111-1295-4030CT-2023-CTN-00033-1-v1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Bronchiectasis; Cystic Fibrosis; Pseudomonas Aeruginosa; Burkholderia Cepacia Infection

Outcome Measures

Primary Outcomes (1)

• The feasibility of the use of ceftolozane/tazobactam given via continuous infusion in an OPAT setting for the treatment of acute exacerbations of CF and bronchiectasis.

  The feasibility of the use of ceftolozane/tazobactam given via continuous infusion in an OPAT setting for the treatment of acute exacerbations of CF and bronchiectasis will be assessed. Feasibility will be determined as a composite of clinical response (as assessed by disease-specific questionnaires, serum inflammatory marker monitoring and spirometry in the case of patients with cystic fibrosis), adverse events and report of relapse of respiratory infection at 3 months.

  Day 0 to day 90 post commencement of intervention.

Secondary Outcomes (3)

• Safety and tolerability

  Day 0 to day 90 post commencement of intervention.

• Relative bacterial load

  Day 0-1, Day 5-7, Day 10-14, Day 28-42

• In vitro antimicrobial susceptibility/resistance

  Day 0-1, Day 5-7, Day 10-14, Day 28-42

Study Arms (1)

Ceftolozane/tazobactam 9g infusion

EXPERIMENTAL

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

Drug: Ceftolozane/tazobactam

Interventions

Ceftolozane/tazobactam DRUG

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

Ceftolozane/tazobactam 9g infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Coast Hospital and Health Service: lead
• The Prince Charles Hospital: collaborator
• Mater: collaborator

MeSH Terms

Conditions

Bronchiectasis; Cystic Fibrosis; Pseudomonas Infections; Burkholderia Infections

Interventions

ceftolozane, tazobactam drug combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Julia J Bashford, BSc, MBBS

  Sunshine Coast University Hospital

  PRINCIPAL INVESTIGATOR

• Andrew Burke, MBBS

  The Prince Charles Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia J Bashford, MBBS FRACP

CONTACT

+61752021071; julia.bashford@health.qld.gov.au

Andrew Burke, MBBS FRACP

CONTACT

Andrew.Burke@health.qld.gov.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 30 patients will be recruited and will receive the study intervention.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available immediately following publication, with there being no pre-determined end date on IPD sharing.
• Access Criteria: Data will be available only to researchers who provide a sound proposal e.g. planned systematic review and meta-analysis.