The aim of this study is to see whether we can safely use blood cultures more efficiently. By using a prediction model, we support the clinical decision to analyse a blood culture. If the chance that this culture yields a positive result is very…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Non-inferiority regarding 30-day mortality.
Secondary outcome
The key secondary outcomes are:
Non-inferiority regarding hospital admissions, length of stay in hospital and
death in hospital.
Furthermore, superiority is examined in a large group of different outcome
measures (either patient-, process- or model-related).
Background summary
Blood cultures are important to detect a bacterium in the bloodstream. Although
such an infection of the bloodstream is uncommon, the blood culture is often
used for fear of missing this diagnosis. As a result, only about 15% of these
cultures yield anything in the emergency room. Unfortunately, half of this
yield is false positive (a bacterium is found, but it is not the cause of the
infection). Patients with false-positive cultures often receive unnecessary
antibiotics, undergo more procedures and, on average, spend longer in hospital.
Our research group has developed a prediction model that can predict the
probability of a positive blood culture. In this study we want to omit the
blood culture analysis if the chance of a positive result is very small.
Preliminary studies have shown that about 30% of blood cultures can safely be
cancelled, while we miss an infection in less than 1% of the cases. If we
analyse 30% less blood cultures, there will also be less false positive
results. This allows us to avoid unnecessary antibiotic administration,
procedures and hospitalization. In this study we want to see whether this can
indeed be done safely and how great the potential benefits are for the patient.
Study objective
The aim of this study is to see whether we can safely use blood cultures more
efficiently. By using a prediction model, we support the clinical decision to
analyse a blood culture. If the chance that this culture yields a positive
result is very small, then we want to withhold this analysis.
Study design
A multicenter randomized controlled non-inferiority trial.
Intervention
The use of the blood culture prediction model, to omit blood cultures analyses
at less than 5% chance of a positive culture.
Study burden and risks
The burden on the patient is minimal, there are no study activities. There is a
minimal risk that omitting the blood culture analysis could lead to a situation
in which we cannot treat the patient with an adequate antibiotic, while we
could have done this with a culture result. However, from previous literature
and validation of our prediction model, it seems that this risk is extremely
small and does not outweigh the potential benefits.
De boelelaan 1117
Amsterdam 1081HV
NL
De boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
All adult patients who have a clinical indication for a blood culture analysis
(according to the treating physician) in the emergency department.
Exclusion criteria
• Central Venous Line (CVL) in situ
• Neutrophil count < 0.5 * 109/L
• Candidemia or S. aureus bacteraemia in the past 3 months.
• Mostly likely diagnosis of endocarditis/spondylodiscitis/infected prosthetic
material
• Incapacitated patients who cannot provide informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81971.000.23 |