Prospective study on the effect of time-shifted telephone reporting of blood culture microscopy
Organizational Data
- DRKS-ID:
- DRKS00014996
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-06-28
- Last update in DRKS:
- 2022-08-10
- Registration type:
- Retrospective
Acronym/abbreviation of the study
AMB-BK-Call
URL of the study
Brief summary in lay language
The blood culture is a central component of sepsis therapy. The aim is the rapid identification and resistance testing of the pathogen to enable targeted antibiotic therapy. In order to be able to adapt the antibiotic therapy as quickly as possible, the intermediate result of the microscopy of Gram staining is communicated to the attending physician. For practical reasons, this notification can only be made during regular office hours. A blood culture which has become positive outside normal office hours will accordingly be given a time delay. The aim of the study is to evaluate the effect of the time-delayed telephone report of blood culture microscopy on the adaptation of antibiotic therapy. This study at the University of Bonn includes all patients over 18 years with first positive blood culture and without palliative therapy concept. The study includes routine diagnostics of the blood cultures and the normal recording of the antibiotic therapy at two time points.
Brief summary in scientific language
This prospective study evaluates the benefit of instant communication of blood culture microscopy. In particular, the aim is to investigate the effect of the time-delayed telephone notification regarding the adaptation of antibiosis. The study includes all hospitalized patients at the University Hospital Bonn between 18 and 99 years, with non-palliative setting and first detection of pathogens in a blood culture.
Health condition or problem studied
- ICD10:
- A41.9 - Sepsis, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Each blood culture that becomes positive during non-working hours is routinely stained and the result is communicated to the physician. During this phone call, the current antibiosis and the exact time are noted. A second query of the antibiosis takes place in two hours. After completing the final result of the identification and susceptibility testing, the antibiotic therapy is evaluated following a standardized protocol. Furthermore, the delay of potentially necessary adaption of the antibiosis is calculated based on the time when the blood culture was initially flagged as positive.
Endpoints
- Primary outcome:
- Average duration of inadequate antibiosis due to delayed communication of blood culture microscopy outside normal office hours. The time the blood culture flagged positive (1), the result of blood culture microscopy (2), the time of the communication of the microscopy together with the current antibiosis (3), the antibiosis two hours after the communication of the microscopy (4) and the final result of the blood culture diagnostics including the identification and the resistances of the pathogen (5) are recorded.
- Secondary outcome:
- 1.) Rate of adequate adjustments of antibiosis after reporting the blood culture microscopy. 2.) Rate of inadequate adjustments of antibiosis after presentation of the blood culture microscopy.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie , Universitätsklinikum Bonn Sigmund-Freud-Str. 25 53127 Bonn Bonn
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2018-06-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2018-09-01
- Target Sample Size:
- 75
- Final Sample Size:
- 152
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 99 Years
- Additional Inclusion Criteria:
- Patients need to be hospitalized at the University Hospital Bonn. Further of each patient only the first positive blood culture within 30 days is included.
Exclusion Criteria
Patients with a palliative setting or without microscopic visible pathogens in the blood culture are excluded.
Addresses
Primary Sponsor
- Address:
- Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie , Universitätsklinikum BonnThomas GehringSigmund-Freud-Straße 2553127 BonnGermany
- Telephone:
- 022828715952
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie, Universitätsklinikum BonnThomas GehringSigmund-Freud-Str. 2553127 BonnGermany
- Telephone:
- 022828715952
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie, Universitätsklinikum BonnThomas GehringSigmund-Freud-Straße 2553127 BonnGermany
- Telephone:
- 022828715952
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie, Universitätsklinikum BonnThomas GehringSigmund-Freud-Str. 2553127 BonnGermany
- Telephone:
- 022828715952
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Institut für Medizinische Mikrobiologie, Immunologie und ParasitologieSigmund-Freud-Straße 2553127 BonnGermany
- Telephone:
- 022828715952
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission Medizinische Fakultät BonnVenusberg Campus 1, Geb. 0253105 BonnGermany
- Telephone:
- +49-228-28751282
- Fax:
- +49-228-28751932
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-05-28
- Ethics committee number:
- 189/18
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- 2018-06-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- A prospective study on the effect of time-shifted telephone reporting of blood culture microscopy
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry