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Model for PK/PD of Antimicrobials in Blood Stream Infection: Feasibility (MOBSI1)

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ClinicalTrials.gov Identifier: NCT04083443
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : January 21, 2020
Sponsor:
Collaborators:
University of Witten/Herdecke
University of Leipzig
University Hospital Munich
Information provided by (Responsible Party):
Prof. Dr. Uwe Fuhr, University of Cologne

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 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.

Condition or disease Intervention/treatment
Blood Stream Infections Other: Additional blood sampling

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 participants, obtaining informed consent, documentation of available potential covariates from patient file, withdrawal of pre-study blood samples (PK, PD, microbiology) including documentation of exact time of sampling and processing of the samples, first drug administration including exact documentation (as part of patient care; not as a study intervention), withdrawal of subsequent blood samples (PK, PD, microbiology) during the next 3 days including documentation of exact time of sampling and processing of the samples, storage of processed samples for further analysis, and, if possible, documentation of patient outcome after 7 days. The following steps are carried out after completion of the clinical part of the study in the individual patient or, when possible, in all patients together or in a subset: Bioanalytics, DNA Counts, assessing primary and secondary study endpoints, pharmacometric analyses including PK parameter estimation, PD parameter estimation and assessment of covariate effects with regard to DNA count, CRP, IL-6 and procalcitonin.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Model Development for Pharmacokinetics / Pharmacodynamics of Antimicrobial Drugs in Blood Stream Infections Part 1: Feasibility Study
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Patients with blood stream infections
Patients with a high probability of a blood stream infection and an indication for antimicrobial treatment. There will be an additional blood sampling for these patients, which is the only intervention in the study.
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.




Primary Outcome Measures :
  1. Fraction of eligible patients [ Time Frame: Screening ]
    Fraction of identified and potentially eligible patients willing and able to provide informed consent

  2. Positive blood microbial DNA count [ Time Frame: Samples for DNA counts are taken for a duration of up to 3 days. ]
    Fraction of study participants having any positive blood microbial DNA count for microbes which does not reflect sample contamination

  3. Fraction of patients with at least three samples with microbial DNA [ Time Frame: Samples for DNA counts are taken for a duration of up to 3 days. ]
    Fraction of study participants with at least three samples with quantifiable microbial DNA along with a proper documentation

  4. Plausible time courses of antimicrobial drug concentrations [ Time Frame: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days. ]
    Fraction of study participants with plausible time courses of antimicrobial drug concentrations along with a proper documentation


Secondary Outcome Measures :
  1. Population pharmacokinetic parameters of drugs studied [ Time Frame: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days. ]
    Pharmacometric analyses including PK parameter estimation

  2. Population pharmacodynamic parameters of drugs studied [ Time Frame: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days. ]
    Population pharmacodynamic parameters of drugs studied with regard to bacterial DNA count, procalcitonin, IL-6 and C-reactive protein



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
For this study, patients with suspected blood stream infection will be enrolled.
Criteria

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 following clinical manifestations:

      1. a body temperature greater than 38°C or less than 36°C
      2. a heart rate greater than 90 beats per minute
      3. 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
      4. 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083443


Contacts
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Contact: Uwe Fuhr, Prof. Dr. +49 221 478 5230 uwe.fuhr@uk-koeln.de
Contact: Dario Zaremba, Dr. +49 221 478 6064 dario.zaremba@uk-koeln.de

Locations
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Germany
Klinik für Anaesthesiologie, Klinikum der Ludwig-Maximilians-Universität München Not yet recruiting
Munich, Bavaria, Germany, 81377
Contact: Michael Zoller, Dr.    +49 89 4400 74551    michael.zoller@med.uni-muenchen.de   
Clinical Infectiology, Klinik I für Innere Medizin, University Hospital Cologne Recruiting
Cologne, North Rhine-Westphalia, Germany, 50937
Contact: Norma Jung, PD Dr.    +49 221 478 3324    norma.jung@uk-koeln.de   
Klinik für Anästhesiologie und Operative Intensivmedizin Krankenhaus Köln-Merheim Klinikum der Universität Witten/ Herdecke Not yet recruiting
Cologne, North Rhine-Westphalia, Germany, 51109
Contact: Samir Sakka, Prof. Dr.    +49 221 8907 13430    sakkas@kliniken-koeln.de   
Universitätsklinikum Leipzig AöR, Klinik für Gastroenterologie und Rheumatologie, Sektion Hepatologie Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Niklas Aehling, Dr.    +49 341 97 12333    niklas.aehling@medizin.uni-leipzig.de   
Contact: Adam Herber       adam.herber@medizin.uni-leipzig.de   
Sponsors and Collaborators
University of Cologne
University of Witten/Herdecke
University of Leipzig
University Hospital Munich
Investigators
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Principal Investigator: Uwe D Fuhr, Prof. Dr. Institut I für Pharmakologie, University of Cologne, Germany
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Responsible Party: Prof. Dr. Uwe Fuhr, Director, Department I of Pharmacology, University of Cologne
ClinicalTrials.gov Identifier: NCT04083443    
Other Study ID Numbers: MOBSI1
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases