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Do not routinely continue hospitalization in well-appearing febrile infants once bacterial cultures have been confirmed negative for 24 to 36 hours if adequate outpatient follow-up can be assured
Culture clear – Outpatient near!

What is known about bacterial blood culture results after 24-36 hours:

  • For infants from 1 to 12 months of age admitted to the hospital due to concerns about a potentially serious bacterial infection, particularly those who appear to be well, extending their hospital stay beyond 24 hours solely to confirm negative cultures offers little benefit and can have harmful side effects such as secondary infections.
  • In a multicenter retrospective cross-sectional study, the mean time to positive blood culture results was found to be
  • 15.41 hours, with over 90% of these blood cultures testing positive within the initial 24 hours. Another study demonstrated that only 0.5% of cases experienced notification times exceeding 24 hours.
  • Stopping antibiotic treatment in well-appearing children within 24-36 hours means shorter hospital stays, less medication, and fewer complications.

How to talk with patients and parents about cough medicine:

  • We know that your baby is safe by the result of the preliminary tests and the observation.
  • Babies and parents thrive at home, and that’s better than being at the hospital for sleep, privacy and comfort, and it also means less exposition to other germs.
  • We have a safety net (emergency room visits, phone checks, direct information of the family doctor etc…)

This EAP recommendation is in accordance with Choosing Wisely recommendations of:

ABIM Foundation, Society of Hospital Medicine, American Academy of Pediatrics, and the American Pediatric Association:
https://downloads.aap.org/AAP/PDF/Choosing%20Wisely/CWHospitalmedicine.pdf

References:

  • Biondi EA, Mischler M, Jerardi KE, Statile AM, French J, Evans R, et al. Blood culture time to positivity in febrile infants with bacteremia. JAMA Pediatr. 2014 Sep;168(9):844–9. PMID: 25048522

  • Dierig A, Berger C, Agyeman PKA, Bernhard-Stirnemann S, Giannoni E, Stocker M, et al. Time-to-Positivity of Blood Cultures in Children With Sepsis. Front Pediatr. 2018;6:222. PMID: 30135859

  • Fielding-Singh V, Hong DK, Harris SJ, Hamilton JR, Schroeder AR. Ruling out bacteremia and bacterial meningitis in infants less than one month of age: is 48 hours of hospitalization necessary? Hosp Pediatr. 2013 Oct;3(4):355–61. PMID: 24435193

  • Lefebvre CE, Renaud C, Chartrand C. Time to Positivity of Blood Cultures in Infants 0 to 90 Days Old Presenting to the Emergency Department: Is 36 Hours Enough? J Pediatric Infect Dis Soc. 2017 Mar 1;6(1):28–32. PMID: 26621327
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Core-MD Project

Coordinating Research and Evidence for Medical Devices (CORE-MD)

New ways to test high-risk medical devices.

 

Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.


It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.

EAP Representative:

  • BERTHOLD KOLETZKO
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