Clinical trial • Phase IV • Respiratory

Piperacillin (as piperacillin sodium / piperacillin monohydrate) and Tazobactam (tazobactam sodium) for Chronic obstructive pulmonary disease | Cystic fibrosis

Phase IV trial of Piperacillin (as piperacillin sodium / piperacillin monohydrate) and Tazobactam (tazobactam sodium) for Chronic obstructive pulmonary di…

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Chronic obstructive pulmonary disease | Cystic fibrosis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
11-12-2024

Trial design

Phase IV trial across 1 site in Austria.

Target Sample Size
18

Eligibility

Recruits 18 Vulnerable population not selected. Participants must provide "Written informed consent"; "Inability to give informed consent" is listed as an exclusion criterion. No assent or minor consent provisions are indicated; age eligibility excludes those <=18..

Vulnerable Population
Vulnerable population not selected. Participants must provide "Written informed consent"; "Inability to give informed consent" is listed as an exclusion criterion. No assent or minor consent provisions are indicated; age eligibility excludes those <=18.

Inclusion criteria

  • {"criterion_text":"- Written informed consent\n- Planned bilateral lung transplantation\n- Diagnosis of COPD or CF\n- Age: > 18 and < 90 years"}

Exclusion criteria

  • {"criterion_text":"- Inability to give informed consent\n- Known allergy to study drugs\n- Prior lung transplantation\n- Preoperative renal failure\n- Chronic severe renal insufficiency including haemodialysis\n- Chronic severe liver disease\n- ECLS bridging"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Antibiotic concentrations in ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.","definition_or_measurement_approach":"Epithelial lining fluid concentrations at 75', tissue biopsy concentrations at 75' and in-vivo microdialysis concentrations during the 60-90' interval will be compared (head-to-head comparison of three methods for measuring pulmonary antibiotic pharmacokinetics)."}

Recruitment

Planned Sample Size
18
Recruitment Window Months
14
Consent Approach
Written informed consent is required from participants (criterion: "Written informed consent"). "Inability to give informed consent" is an exclusion. A Subject information and informed consent form document is listed (L1_ SIS and ICF_redacted). No assent procedures or age-specific consent documents or languages are specified in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
18

Austria

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
36
Number Of Sites
1
Number Of Participants
18

Sites

Site Name
Medical University Of Vienna
Department Name
Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine
Contact Person Name
Doris Hutschala-Kinstner

Sponsor

Primary sponsor

Full Name
Medical University Of Vienna
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
Piperacillin/Tazobactam Kabi 4 g/0,5 g Pulver zur Herstellung einer Infusionslösung
Active Substance
Piperacillin (as piperacillin sodium / piperacillin monohydrate) and Tazobactam (tazobactam sodium)
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation information present, prodAuthStatus:2)
Maximum Dose
13.5 g (maxDailyDoseAmount: 13.5, doseUom: g)
Investigational Product Name
Levofloxacin Kabi 5 mg/ml Infusionslösung
Active Substance
Levofloxacin hemihydrate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation information present, prodAuthStatus:2)
Maximum Dose
1000 g (maxDailyDoseAmount: 1000, doseUom: g)

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