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Steady State Serum and Epithelial Lining Fluid (ELF) Antibiotics Concentrations Under Continous Infusion
This study has been terminated.
Sponsored by: University Hospital Tuebingen
Information provided by: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00435305
  Purpose

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.


Condition Intervention Phase
Pneumonia
Bacteremia
Drug: Meropenem
Drug: Vancomycin
Drug: Linezolid
Drug: Piperacillin/Tazobactam
Drug: Cefepim
Drug: Ceftazidim
Phase IV

MedlinePlus related topics: Antibiotics Pneumonia
Drug Information available for: Vancomycin Meropenem Ceftazidime Cefepime Cefepime hydrochloride Linezolid Vancomycin hydrochloride Piperacillin Piperacillin sodium Tazobactam
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Antibiotic Concentrations in Serum and Epithelial Lining Fluid Under Continous Infusion

Further study details as provided by University Hospital Tuebingen:

Estimated Enrollment: 40
Study Start Date: November 2006
Estimated Study Completion Date: November 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435305

Locations
Germany
Universitäsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Study Chair: Wolfgang Krueger, PHD Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin
  More Information

Study ID Numbers: 2005-002128-32
Study First Received: February 13, 2007
Last Updated: June 6, 2008
ClinicalTrials.gov Identifier: NCT00435305  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
continuous infusion
epithelial lining fluid
antibiotics
pneumonia
critical illness

Study placed in the following topic categories:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Bacteremia
Tazobactam
Piperacillin-tazobactam combination product
Inflammation
Ceftazidime
Sepsis
Penicillanic Acid
Cefepime
Respiratory Tract Diseases
Respiratory Tract Infections
Critical Illness
Lung Diseases
Meropenem
Vancomycin
Piperacillin
Linezolid
Pneumonia

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009