Characterization of lung concentrations of the antibiotics piperacillin/tazobactam and levofloxacin

Pulmonary pharmacokinetics of piperacillin/tazobactam and levofloxacin in patients with chronic obstructive pulmonary disease or cystic fibrosis: Comparison of epithelial lining fluid, in-vivo microdialysis and tissue biopsy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000955-16-AT

Enrollment

Registered

2020-01-07

Start date

2020-01-28

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Interventions

Trade Name: Piperacillin/Tazobactam "Kabi" - Fresenius Kabi Austria Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: piperacillin CAS Number: 59703-84-3 Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Written informed consent • Planned bilateral lung transplantation • Diagnosis of COPD or CF • Age:>18and=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Inability to give informed consent • Known allergy to study drugs • Prior lung transplantation • Preoperative renal failure • Chronic severe renal insufficiency including haemodialysis • Chronic severe liver disease • ECLS bridging

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is the head-to-head comparison of three methods for measuring pulmonary antibiotic pharmacokinetics. Epithelial lining fluid concentrations at 75', tissue biopsy concentrations at 75' and in- vivo microdialysis concentrations during the 60-90' interval will be compared.;Secondary Objective: 1) ELF concentrations at 135', tissue biopsy concentrations at 135' and in-vivo microdialysis concentrations during the 120-150' interval will be compared. 2) Pulmonary pharmacokinetics of commonly used antibiotics for surgical prophylaxis and treatment of pulmonary infections in patients with severe COPD or CF, two chronic pulmonary disorders with distinct histopathological findings, will be evaluated by means of drug-specific PK/PD indices. The duration of time that free drug concentrations remain above the MIC during the dosing interval in % (%fT>MIC) will be used for piperacillin/tazobactam. The ratio of AUC over 24h to MIC (AUC0-24/MIC) will be used for levofloxacin.;Primary end point(s): Primary endpoint Antibiotic concentrations in ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.;Timepoint(s) of evaluation of this end point: ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.	—

Measure

Time frame

Main Objective: The primary objective is the head-to-head comparison of three methods for measuring pulmonary antibiotic pharmacokinetics. Epithelial lining fluid concentrations at 75', tissue biopsy concentrations at 75' and in- vivo microdialysis concentrations during the 60-90' interval will be compared.;Secondary Objective: 1) ELF concentrations at 135', tissue biopsy concentrations at 135' and in-vivo microdialysis concentrations during the 120-150' interval will be compared. 2) Pulmonary pharmacokinetics of commonly used antibiotics for surgical prophylaxis and treatment of pulmonary infections in patients with severe COPD or CF, two chronic pulmonary disorders with distinct histopathological findings, will be evaluated by means of drug-specific PK/PD indices. The duration of time that free drug concentrations remain above the MIC during the dosing interval in % (%fT>MIC) will be used for piperacillin/tazobactam. The ratio of AUC over 24h to MIC (AUC0-24/MIC) will be used for levofloxacin.;Primary end point(s): Primary endpoint Antibiotic concentrations in ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.;Timepoint(s) of evaluation of this end point: ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints 1) Antibiotic concentrations in ELF and tissue biopsy at 135' and in-vivo microdialysis concentrations during the 120-150' interval. 2) Calculation of PK/PD indices: The duration of time that free drug concentrations remain above the MIC during the dosing interval in % (%fT>MIC) will be used for piperacillin/tazobactam. The ratio of AUC over 24h to MIC (AUC0-24/MIC) will be used for levofloxacin.;Timepoint(s) of evaluation of this end point: ELF and tissue biopsy at 135' and in-vivo microdialysis concentrations during the 120-150' interval. Blood and microdialysis samples at 0, 30, 60, 90, 120, 150, 180 and 210 min	—

Measure

Time frame

Secondary end point(s): Secondary endpoints 1) Antibiotic concentrations in ELF and tissue biopsy at 135' and in-vivo microdialysis concentrations during the 120-150' interval. 2) Calculation of PK/PD indices: The duration of time that free drug concentrations remain above the MIC during the dosing interval in % (%fT>MIC) will be used for piperacillin/tazobactam. The ratio of AUC over 24h to MIC (AUC0-24/MIC) will be used for levofloxacin.;Timepoint(s) of evaluation of this end point: ELF and tissue biopsy at 135' and in-vivo microdialysis concentrations during the 120-150' interval. Blood and microdialysis samples at 0, 30, 60, 90, 120, 150, 180 and 210 min

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Countries

Austria

Contacts

Public ContactDepartment of Cardiac Anaesthesia

Medical University Vienna

htg@meduniwien.ac.at004314040041090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026