NCT00435305

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

June 9, 2008

Status Verified

June 1, 2008

First QC Date

February 13, 2007

Last Update Submit

June 6, 2008

Conditions

PneumoniaBacteremia

Keywords

continuous infusionepithelial lining fluidantibioticspneumoniacritical illness

Interventions

MeropenemDRUG
VancomycinDRUG
LinezolidDRUG
Piperacillin/TazobactamDRUG
CefepimDRUG
CeftazidimDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

PneumoniaBacteremiaCritical Illness

Interventions

MeropenemVancomycinLinezolidPiperacillin, Tazobactam Drug CombinationCefepimeCeftazidime

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesBacterial InfectionsBacterial Infections and MycosesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsAcetamidesAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingTazobactamPenicillanic AcidPenicillinsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesDrug CombinationsPharmaceutical PreparationsCephalosporinsThiazinesCephaloridine

Study Officials

  • Wolfgang Krueger, PHD

    Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2007

First Posted

February 14, 2007

Study Start

November 1, 2006

Study Completion

November 1, 2007

Last Updated

June 9, 2008

Record last verified: 2008-06

Locations

DE(1)