A brief update on the ESBL predict study, after the last update from 6 months ago. Tim Deelen from our group is still running the show and we are still seeking hospitals for participation. It’s for free, it’s easy, relevant and fun! We passed the 5,500 episodes and we learn a lot, including how countries deal with the ethical aspects of this study.
Ethics? To be clear: the study does not involve the intrathecal injection of vincristine. It’s just the prospective collection of culture results and antibiotic prescription data. In short: Wouter Rottier developed 2 prediction rules (for community-onset and hospital-onset infection) for predicting the presence of ESBL-producing bacteria as a cause of infection at the time antibiotics must be started. The manuscript has now been accepted in CMI. As these rules did a better job in predicting than current guideline recommendations (especially for reducing unnecessary carbapenem use) when derived, external validation is needed. So, we created an eCRF for the scores at the day empiric treatment starts (5 minutes work) and to enter culture results 5 days later (another 2 minutes). We now have data in from 11 countries and 156 episodes of bacteremia caused by ESBL-producing bacteria (2.9%). Some preliminary results will be presented at ECCMID (poster).
High on our wish list for participating countries was Denmark. That country has the reputation that – in health care – everything is registered and can be combined, and that pragmatism and reality sense entered the Danish pangenome long time ago. Well, apparently some essential genes have mutated. We learned that Danish clinical microbiologists are “not allowed to examine the medical files of patients with a negative blood culture, as they are not considered a part of department of microbiology routine work-up.” Too bad, but I am happy that medical ethics do everything necessary to protect vulnerable Danish patients from aggressive Dutch investigators.
I wonder whether a physician-patient relationship is considered to exist before the blood culture becomes positive. And whether a microbiologist or infectious disease specialist would be allowed to examine medical files, until the minute that a blood culture would be reported as negative. If that is the case we could ask the Danes to consider each infection episode as a potential endocarditis lenta, for which blood cultures need weeks of incubation…..
Interested in participation? You can still join the “ESBL-prediction movement”. For more details (e.g., coauthor rules) contact Tim Deelen: j.w.t.deelen@umcutrecht.nl; telephone +31 88 7569409