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. An exploratory pharmacokinetic study.

2024-518337-29-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 11 Dec 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 18
Countries 1
Sites 1

chronic obstructive pulmonary disease

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.

Key facts

Sponsor
Medical University Of Vienna
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
11 Dec 2024 → ongoing
Decision date (initial)
2024-12-11
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518337-29-00
EudraCT number
2019-000955-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

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.

Conditions and MedDRA coding

chronic obstructive pulmonary disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Written informed consent
  2. Planned bilateral lung transplantation
  3. Diagnosis of COPD or CF
  4. Age: > 18 and < 90 years

Exclusion criteria 7

  1. Inability to give informed consent
  2. Known allergy to study drugs
  3. Prior lung transplantation
  4. Preoperative renal failure
  5. Chronic severe renal insufficiency including haemodialysis
  6. Chronic severe liver disease
  7. ECLS bridging

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Antibiotic concentrations in ELF and tissue biopsy at 75' and in-vivo microdialysis concentrations during the 60-90' interval.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Piperacillin/Tazobactam Kabi 4 g/0,5 g Pulver zur Herstellung einer Infusionslösung

PRD767217 · Product

Active substance
Piperacillin Sodium
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
13.5 g gram(s)
Max total dose
13.5 g gram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
Marketing authorisation
1-27840
MA holder
FRESENIUS KABI AUSTRIA GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levofloxacin Kabi 5 mg/ml Infusionslösung

PRD409081 · Product

Active substance
Levofloxacin Hemihydrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1000 g gram(s)
Max total dose
1000 g gram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J01MA12 — LEVOFLOXACIN
Marketing authorisation
1-29202
MA holder
FRESENIUS KABI AUSTRIA GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

83 Total trials 57 Recruiting 12 Ended
Academic / Non-commercial
Sponsor organisation
Medical University Of Vienna
Address
Spitalgasse 23, Alsergrund Alsergrund
City
Vienna
Postcode
1090
Country
Austria

Scientific contact point

Organisation
Medical University Of Vienna
Contact name
Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine

Public contact point

Organisation
Medical University Of Vienna
Contact name
Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 18 1
Rest of world — 0 —

Investigational sites

Austria

1 site · Ongoing, recruiting
Medical University Of Vienna
Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine, Waehringer Guertel 18-20, Alsergrund, Vienna

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2024-12-11 2024-12-11

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-518337-29-00_redacted 2
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_ SIS and ICF_redacted 4

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-15 Austria Acceptable
2024-12-06
 2024-12-11

Related clinical trials