This investigator-initiated randomized controlled trial compares the clinical impact of real time PCR of fecal samples in children with acute gastrointestinal symptoms at a pediatric emergency room. Specifically, the trial compares immediate testing of fecal samples using a multiplex PCR panel to a a control group with delayed test results.
Child or adolescent < 16 years of age
Visiting pediatric ED
Presence of gastrointestinal symptom or symptoms (diarrhea, vomiting or abdominal pain)
Need of cardiopulmonary resuscitation at the ED
Need of immediate transfer to the intensive care unit
Hemato-oncological disease
Severe immunosuppression
Parallel
Multiplex PCR gastrointestinal panel
Diagnostic testIntervention includes a rapid use of multiplex PCR panel for gastrointestinal pathogens of fecal samples from children with acute gastrointestinal symptoms evaluated at a pediatric emergency room
Impact on clinical decision making
Primary outcome comprises the proportion of participants with 1) targeted antimicrobial therapy based on PCR results 2) untargeted antimicrobial therapy avoided based on PCR result, OR 3) specific clinical follow up planned based on PCR result, namely EHEC infection
Proportion of children with correctly targeted antimicrobial therapy
Proportion of children with correctly targeted antimicrobial therapy based on PCR results
Proportion of children needing hospitalization or specific follow up
Proportion of children needing hospitalization or specific follow up
Time to receive the laboratory results
Time (hours) from the initial presentation at the ED to the laboratory results given to the clinicians
Length of stay
Length of hospital stay, time (hours) before discharge
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University of Oulu
Lead sponsor
Oulu University Hospital
Collaborator
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