Abstract
IntroductionBacterial infection represents a serious risk in neonates and critically ill paediatric patients. Current clinical practice is characterized by frequent antibiotic treatment despite low incidence of true infection. However, some patients escape early diagnosis and progress to septic shock. Many new markers, including cytokines, have been suggested to improve decision making, but the clinical efficacy of these techniques remains uncertain. Therefore, we will test the clinical efficacy of a previously validated diagnostic strategy to reduce antibiotic usage and nosocomial infection related morbidity.MethodsAll patients admitted to the multidisciplinary neonatal and paediatric intensive care unit of a university children's hospital will be included. Patients will be allocated either to routine sepsis work up or to the intervention strategy with additional cytokine measurements. Physicians will be requested to estimate the pre-test probability of sepsis and pneumonia at initial suspicion. In the treatment arm, physicians will receive raw cytokine results, the likelihood ratio and the updated post-test probability. A high post-test probability will suggest that immediate initiation of antibiotic treatment is appropriate, whereas a low post-test probability will be supportive of watchful waiting or discontinuing prophylactic empirical therapy. Physicians may overrule the suggestions resulting from the post-test probability.ConclusionThis trial will ascertain the clinical efficacy of introducing new diagnostic strategies consisting of pre-test probability estimate, novel laboratory markers, and computer-generated post-test probability in infectious disease work up in critically ill newborns and children.
Highlights
Bacterial infection represents a serious risk in neonates and critically ill paediatric patients
The high risks associated with untreated infection and the lack of accurate clinical or laboratory prediction methods result in a low threshold for initiating empirical antibiotic therapy
We previously reported diagnostic test accuracy studies in which we derived a prediction model based on the measurement of plasma levels of granulocyte colony-stimulating factor (GCSF) and IL-8, and tracheal aspirate levels of G-CSF [9,10]
Summary
Bacterial infection represents a serious risk in neonates and critically ill paediatric patients. Current clinical practice is characterized by frequent antibiotic treatment despite low incidence of true infection. We will test the clinical efficacy of a previously validated diagnostic strategy to reduce antibiotic usage and nosocomial infection related morbidity. Bacterial infection is an important cause of mortality and morbidity in newborns and critically ill paediatric patients [1,2]. The high risks associated with untreated infection and the lack of accurate clinical or laboratory prediction methods result in a low threshold for initiating empirical antibiotic therapy. In neonatal and paediatric intensive care, antibiotic therapy is used in as many as 80% of patients, with an average of about 50% [3].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
