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

NCT04083443 | Unknown

• 1 other identifier: MOBSI1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Blood Stream Infections

Outcome Measures

Primary Outcomes (4)

• Fraction of eligible patients

  Fraction of identified and potentially eligible patients willing and able to provide informed consent

  Screening

• Positive blood microbial DNA count

  Fraction of study participants having any positive blood microbial DNA count for microbes which does not reflect sample contamination

  Samples for DNA counts are taken for a duration of up to 3 days.

• Fraction of patients with at least three samples with microbial DNA

  Fraction of study participants with at least three samples with quantifiable microbial DNA along with a proper documentation

  Samples for DNA counts are taken for a duration of up to 3 days.

• Plausible time courses of antimicrobial drug concentrations

  Fraction of study participants with plausible time courses of antimicrobial drug concentrations along with a proper documentation

  Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.

Secondary Outcomes (2)

• Population pharmacokinetic parameters of drugs studied

  Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.

• Population pharmacodynamic parameters of drugs studied

  Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.

Study Arms (1)

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

Interventions

Additional blood sampling OTHER

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.

Patients with blood stream infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For this study, patients with suspected blood stream infection will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• University of Witten/Herdecke: collaborator
• University of Leipzig: collaborator
• University Hospital Munich: collaborator

Study Sites (4)

Klinik für Anaesthesiologie, Klinikum der Ludwig-Maximilians-Universität München

Munich, Bavaria, 81377, Germany

NOT YET RECRUITING

Clinical Infectiology, Klinik I für Innere Medizin, University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Klinik für Anästhesiologie und Operative Intensivmedizin Krankenhaus Köln-Merheim Klinikum der Universität Witten/ Herdecke

Cologne, North Rhine-Westphalia, 51109, Germany

NOT YET RECRUITING

Universitätsklinikum Leipzig AöR, Klinik für Gastroenterologie und Rheumatologie, Sektion Hepatologie

Leipzig, Saxony, 04103, Germany

RECRUITING

Study Officials

• Uwe D Fuhr, Prof. Dr.

  Institut I für Pharmakologie, University of Cologne, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uwe Fuhr, Prof. Dr.

CONTACT

+49 221 478 5230; uwe.fuhr@uk-koeln.de

Dario Zaremba, Dr.

CONTACT

+49 221 478 6064; dario.zaremba@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department I of Pharmacology

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: July 23, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 21, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)