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TerminatedNCT00435305Updated Jun 9, 2008

Steady State Serum and Epithelial Lining Fluid (ELF) Antibiotics Concentrations Under Continous Infusion

An observational study in Pneumonia and Bacteremia, sponsored by University Hospital Tuebingen. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-09.

Sponsored by University Hospital Tuebingen · Observational

Why this study was terminated
difficulties by enrolling patients fundings consumed, no staff could be recruited and payed to continue enrolling patients,
Study type
Observational
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of our study is to determine the penetration of continuously infused antibiotics at steady state, mainly Meropenem, Vancomycin, Linezolid, Piperacillin/tazobactam and additionally cefepim and ceftazidim, into epithelial lining fluid.

Read the detailed description

Severe infectious disease may be the cause for admitting a patient to an ICU, but more often they constitute a complication of the intensive care and turn out to be caused by nosocomial pathogens.

Nosocomial infections are associated with a high lethality. The appropriate antibiotic therapy determines in part the outcome of the patients. Especially this antibiotic therapy implicates a number of problems for the physician.

He has to ensure that the chosen antibiotics are effective against the most common and presumed pathogens and that the reached concentrations of antibiotics in plasma and epithelial lining fluid are reliably and permanently above the minimal inhibitory concentration (MIC) for the given pathogens.

All the antibiotics included in our clinical trial are so called "time dependent" antibiotics. They are most effective if there concentrations reach a certain level (MIC) at the infected site (epithelial lining fluid in our study) over the entire period of treatment.

To achieve this aim, many authors already suggested that the continuous infusion might solve the problem of too low antibiotic plasma and ELF levels. Studies about pharmacokinetics of continuous infused antibiotics, which were conducted in healthy volunteers or patients with normal organ function, cannot be assigned to critical ill patients. Rationales for this statement are that data about plasma and tissue levels of antibiotics in critical ill patients are highly influenced by modified volume of distribution, elimination half-life period and impaired tissue perfusion compared to healthy volunteers. These physiological variances implicate that the response to the antibiotic treatment remains doubtful. Under these pathophysiological conditions, data about antibiotics plasma and ELF levels may provide additional information in order to adjust the dosing regime of antibiotics.

Studies conducted in critical ill patients showed that under the circumstances of continuous infused antibiotics, the reached levels in plasma are above the MIC. However there is little data about penetration into ELF of continuous infused antibiotics.

Our study intends to provide data about plasma and ELF levels of continuous infused antibiotics in steady state, determine a penetration coefficient for these antibiotics into ELF and to compare the reached levels in ELF to the MIC.

To demonstrate the efficiency of continuous infused antibiotics, we will conduct quantitative microbiological measurements before and after treatment if applicable.

02

Conditions studied

  • Pneumonia
  • Bacteremia

Keywords

  • continuous infusion
  • epithelial lining fluid
  • antibiotics
  • pneumonia
  • critical illness
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 40 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients of both gender >0 18 years of age
  • Patients of an ICU with one or more of the following infections
  • Bacteremia. sepsis
  • pneumonia
  • tracheo-bronchitis
  • mechanical ventilation
  • stay on the ICU >= 3 days
  • indication for bronchoscopy

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • allergy against the studied drug
  • known resistance of the involved pathogen against the study drug
  • simultaneous participation in other studies
  • former participation in the present study
  • probable stay on the ICU \< 3 days
  • contra-indication against the study-drug
  • contra-indication for bronchoscopy
05

Study design

Time perspective
Prospective
Enrollment
40 participants (estimated)

Interventions

  • DrugMeropenem
  • DrugVancomycin
  • DrugLinezolid
  • DrugPiperacillin/Tazobactam
  • DrugCefepim
  • DrugCeftazidim
06

Study locations

1 site
  • Universitäsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin
    Tübingen, 72076, Germany
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00435305
Lead sponsor
University Hospital Tuebingen
First posted
Feb 14, 2007
Start date
Nov 2006
Completion
Nov 2007 (estimated)
Last update
Jun 9, 2008

Study contacts

Wolfgang Krueger, PHD
study chair · Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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