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

June 6, 2008 updated by: University Hospital Tuebingen

Antibiotic Concentrations in Serum and Epithelial Lining Fluid Under Continous Infusion

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • Universitäsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Study Chair: Wolfgang Krueger, PHD, Universitatsklinikum Tubingen, Klinik fur Anasthesiologie und Intensivmedizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Anticipated)

November 1, 2007

Study Registration Dates

First Submitted

February 13, 2007

First Submitted That Met QC Criteria

February 13, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2008

Last Update Submitted That Met QC Criteria

June 6, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-002128-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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