Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 followingclinical 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 perminute, 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 10percent immature neutrophils ("bands"). and
the assessment of the treating physician according to the patient's situationthat the SIRS is caused by an infection (e.g., patients after treatment withcytotoxic 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 ofother 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 ampleinformation has been provided
Exclusion
Exclusion Criteria:
expected chances to successfully carry out venipunctures to obtain the blood samplesrequired for the study are inadequately low according to the assessment of thephysician
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 thepatient or other conditions would make participation on the study inappropriate (e.g.,terminally ill patients); the respective assessment is done by the treating physician
Study Design
Study Description
Connect with a study center
Klinik für Anaesthesiologie, Klinikum der Ludwig-Maximilians-Universität München
Munich, Bavaria 81377
GermanySite Not Available
Clinical Infectiology, Klinik I für Innere Medizin, University Hospital Cologne
Cologne, North Rhine-Westphalia 50937
GermanyActive - Recruiting
Klinik für Anästhesiologie und Operative Intensivmedizin Krankenhaus Köln-Merheim Klinikum der Universität Witten/ Herdecke
Cologne, North Rhine-Westphalia 51109
GermanySite Not Available
Universitätsklinikum Leipzig AöR, Klinik für Gastroenterologie und Rheumatologie, Sektion Hepatologie
Leipzig, Saxony 04103
GermanyActive - Recruiting
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