Status:
UNKNOWN
Model for PK/PD of Antimicrobials in Blood Stream Infection: Feasibility
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
University of Witten/Herdecke
University of Leipzig
Conditions:
Blood Stream Infections
Eligibility:
All Genders
18+ years
Brief 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 s...
Detailed Description
Patients with a high probability of a blood stream infection and an indication for antimicrobial treatment will be included. The study comprises the identification of patients as potential study parti...
Eligibility Criteria
Inclusion
- High probability of a blood stream infection; this is based on
- the presence of SIRS \[Bone et al. 1992\] defined by more than one of the following clinical manifestations:
- a body temperature greater than 38°C or less than 36°C
- a heart rate greater than 90 beats per minute
- tachypnea, manifested by a respiratory rate greater than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less than 32 mm Hg
- an alteration in the white blood cell count, such as a count greater than 12,000/µl, a count less than 4,000/µl, or the presence of more than 10 percent immature neutrophils ("bands").
- and
- the assessment of the treating physician according to the patient's situation that the SIRS is caused by an infection (e.g., patients after treatment with cytotoxic drugs)
- indication for antimicrobial treatment
- Intended use of one of the following antimicrobial agents:
- piperacillin/tazobactam; vancomycin; meropenem; ampicillin/sulbactam; flucloxacillin; ceftriaxone; caspofungin (according to the decision of the project coordinator, use of other antimicrobial agents may also be included if anticipated to be used frequently)
- Age: 18 years or older (no upper limit)
- Willing and capable to provide written consent prior to enrolment after ample information has been provided
Exclusion
- expected chances to successfully carry out venipunctures to obtain the blood samples required for the study are inadequately low according to the assessment of the physician
- Anemia CTCAE grade \>2 (i.e., Hb \<8.0 g/dL / 4.9 mmol/L)
- the clinical status of the patients suggests that the anticipated treatment of the patient or other conditions would make participation on the study inappropriate (e.g., terminally ill patients); the respective assessment is done by the treating physician
Key Trial Info
Start Date :
July 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04083443
Start Date
July 23 2019
End Date
August 1 2021
Last Update
January 21 2020
Active Locations (4)
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1
Klinik für Anaesthesiologie, Klinikum der Ludwig-Maximilians-Universität München
Munich, Bavaria, Germany, 81377
2
Clinical Infectiology, Klinik I für Innere Medizin, University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany, 50937
3
Klinik für Anästhesiologie und Operative Intensivmedizin Krankenhaus Köln-Merheim Klinikum der Universität Witten/ Herdecke
Cologne, North Rhine-Westphalia, Germany, 51109
4
Universitätsklinikum Leipzig AöR, Klinik für Gastroenterologie und Rheumatologie, Sektion Hepatologie
Leipzig, Saxony, Germany, 04103