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Model for PK/PD of Antimicrobials in Blood Stream Infection: Feasibility

NCT04083443 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2020-01-21

No results posted yet for this study

Summary

The current study is a pilot study to assess the feasibility of a superordinate project. The final objective of this superordinate project is to describe and model the pharmacokinetic behaviour of a small number of standard antimicrobials used in the treatment of frequent blood stream infections, and to link this via pharmacodynamic models to (inhibition of) bacterial or fungal growth as well as to clinical outcomes in patients.

Conditions

  • Blood Stream Infections

Interventions

OTHER

Additional blood sampling

Blood samples will be taken to assess antimicrobial drug concentrations and microbial DNA blood counts. Per patient, at least 5 and up to 15 samples for drug concentrations and at least 3 and up to 6 samples for DNA counts are taken for a duration of up to 3 days.

Sponsors & Collaborators

  • University of Witten/Herdecke

    collaborator OTHER

  • University of Leipzig

    collaborator OTHER

  • University Hospital Munich

    collaborator OTHER

  • University of Cologne

    lead OTHER

Principal Investigators

  • Uwe D Fuhr, Prof. Dr. · Institut I für Pharmakologie, University of Cologne, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04083443 on ClinicalTrials.gov