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2024-518337-29-00RecruitingPhase 4

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.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
18 (estimated)
First submitted
15 Oct 2024
Start date
11 Dec 2024
Lead sponsor
Medical University Of Vienna
EU CT number
2024-518337-29-00
EudraCT number
2019-000955-16

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 18
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior lung transplantation

Other illness

  • Known allergy to study drugs
  • Preoperative renal failure
  • Chronic severe renal insufficiency including haemodialysis
  • Chronic severe liver disease

Other

  • Inability to give informed consent
  • ECLS bridging

Who the study is looking for

  • Written informed consent
  • Planned bilateral lung transplantation
  • Diagnosis of COPD or CF
  • Age: > 18 and < 90 years

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medical University of ViennaViennaAustriaRecruiting

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