Blood Stream InfectionsMOBSI1NCT04083443
Model for PK/PD of Antimicrobials in Blood Stream Infection: Feasibility
An observational study of Blood Stream Infections, run by University of Cologne at 4 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Stream Infections
- What is being tested?
- Additional blood sampling
- How many people
- 120 participants
- Where
- 4 sitesGermany
- Study dates
- 23 Jul 2019to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For this study, patients with suspected blood stream infection will be enrolled.
Who may be able to join
- 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").
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- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 4 recruiting
- Recruiting
Clinical Infectiology, Klinik I für Innere Medizin, University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Norma Jung, PD Dr., +49 221 478 3324, norma.jung@uk-koeln.de
- Not yet recruiting
Klinik für Anästhesiologie und Operative Intensivmedizin Krankenhaus Köln-Merheim Klinikum der Universität Witten/ Herdecke
Cologne, North Rhine-Westphalia, 51109
Samir Sakka, Prof. Dr., +49 221 8907 13430, sakkas@kliniken-koeln.de
- Recruiting
Universitätsklinikum Leipzig AöR, Klinik für Gastroenterologie und Rheumatologie, Sektion Hepatologie
Leipzig, Saxony, 04103
Niklas Aehling, Dr., +49 341 97 12333, niklas.aehling@medizin.uni-leipzig.de
Adam Herber, adam.herber@medizin.uni-leipzig.de
- Not yet recruiting
Klinik für Anaesthesiologie, Klinikum der Ludwig-Maximilians-Universität München
Munich, Bavaria, 81377
Michael Zoller, Dr., +49 89 4400 74551, michael.zoller@med.uni-muenchen.de
About this study
Official title: Model Development for Pharmacokinetics / Pharmacodynamics of Antimicrobial Drugs in Blood Stream Infections Part 1: Feasibility Study
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.
Read the 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.
- Conditions
- Blood Stream Infections
- Being tested
- Additional blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Additional blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of eligible patients
Fraction of identified and potentially eligible patients willing and able to provide informed consent
Measured: 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
Measured: 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
Measured: 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
Measured: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.
Secondary outcomes (2)
Population pharmacokinetic parameters of drugs studied
Pharmacometric analyses including PK parameter estimation
Measured: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.
Population pharmacodynamic parameters of drugs studied
Population pharmacodynamic parameters of drugs studied with regard to bacterial DNA count, procalcitonin, IL-6 and C-reactive protein
Measured: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start23 Jul 2019
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stream InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witten/Herdecke, University of Leipzig, University Hospital Munich
- Responsible party
- Principal investigator, Prof. Dr. Uwe Fuhr, University of Cologne
- Investigators
- Uwe D Fuhr, Prof. Dr., Principal investigator, Institut I für Pharmakologie, University of Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083443
- Sponsor's protocol ID
- MOBSI1
- Acronym
- MOBSI1
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model Development for Pharmacokinetics / Pharmacodynamics of Antimicrobial Drugs in Blood Stream Infections Part 1: Feasibility Study
- ClinicalTrials.gov ID
- NCT04083443
- Acronym / sponsor ID
- MOBSI1 / MOBSI1
- Conditions
- Blood Stream Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- University of Witten/Herdecke, University of Leipzig, University Hospital Munich
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with blood stream infections | – | Other: Additional blood samplingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, patients with suspected blood stream infection will be enrolled.
Key inclusion criteria (13 listed)
- High probability of a blood stream infection; this is based on
- and
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional blood samplingBlood 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. | Other | Patients with blood stream infections |
Primary outcome
Fraction of eligible patients
Time frame: Screening
Fraction of identified and potentially eligible patients willing and able to provide informed consent
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
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
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
2 secondary outcomes
Population pharmacokinetic 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
Time frame: Samples for antimicrobial drug concentrations are taken for a duration of up to 3 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe D Fuhr, Prof. Dr. principal investigator
Institut I für Pharmakologie, University of Cologne, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Stream Infections, run by University of Cologne at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uwe Fuhr, Prof. Dr. (+49 221 478 5230, uwe.fuhr@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of eligible patients (time frame: Screening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.