Abdominal Pain/ Discomfort, Gastroenteritis Acute, Gastrointestinal Symptoms, Vomiting in Infants and/or Children
Conditions
Keywords
Multiplex PCR, Fecal samples, Diagnostic stewardship, Diarrhea, Vomiting, Abdominal pain, Gastrointestinal symptoms, Pediatrics, Children, Emergency department
Brief summary
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.
Detailed description
Acute gastroenteritis is one of the most common reasons for pediatric emergency visits in both general and pediatric emergency departments. For most of the children rehydration is the only therapy needed. However, a range of bacterial pathogens and parasites may need accurate diagnosis and targeted antimicrobial therapy. Use of molecular multiplex testing has increased detection of pathogens in children with acute gastrointestinal symptoms. The PCR tests currently available enable rapid identification of gastrointestinal pathogens, with the test results often being available during the day sample was taken. However, it is unclear which of the patients are most likely to benefit from testing. Also, there is considerable uncertainty about the cost-effectiveness of the multiplex panels used to test for suspected infectious gastroenteritis in hospital and community settings. The previous study by the research group demonstrated that acute gastrointestinal symptoms are one of the most common diagnoses and a major cost in high-income population. The main hypothesis of the study is that real time multiplex PCR testing for gastrointestinal pathogens at pediatric emergency department setting could provide clinical benefit by allowing 1) earlier initiation of appropriate antimicrobial treatment, 2) reduce use of unnecessary antimicrobial treatment and 3) improve identification of conditions in need for follow-up. To estimate the usefulness of real time multiplex PCR testing, an investigator-driven academic randomized (1:1) controlled trial will be conducted at the Pediatric Emergency Department of Oulu University Hospital, Finland. For eligibility, children aged under 16 years arriving to pediatric emergency due to acute gastrointestinal symptoms will be assessed. After obtaining the written consent, fecal specimens will be collected by the nurses from the first stool after arriving to hospital. Multiplex PCR detects 13 gastrointestinal bacterial pathogens, 5 viral pathogens ands 4 parasitic species. QIAStat-Dx gastrointestinal panel 2 will be used. The trial will compare two groups: 1. Intervention group will be tested by a relay-time PCR panel as soon as the fecal sample will arrive in the laboratory and the results will be given to the clinical physicians 2. Control group will undergo similar sampling as the intervention group but the results will be made available after 72 hours of sampling. The composite primary outcome consists of three outcomes which are evaluated using medical records: 1) correctly targeted antimicrobial treatment, 2) untargeted antimicrobial treatment and 3) identification of conditions that require specific follow-up such as shiga-toxin producing EHEC. Secondary outcomes, evaluated by medical records and electronic survey sent to families two weeks after the study visit, include: proportion of correctly targeted antimicrobial treatment, proportion of untargeted antimicrobial treatment, proportion of conditions in need for hospitalization or specific follow-up, time needed for clinician to receive the results of the samples, length of hospital stay, time to correct diagnosis, resolution of symptoms, laboratory and radiology costs, total costs, need for surgical consultation and proportion of patients needing surgical procedure, proportion of unscheduled revisits and proportion of correctly used hospital infection control measures.
Interventions
DIAGNOSTIC_TESTMultiplex PCR gastrointestinal panel
Intervention 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
Sponsors
Oulu University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* Child or adolescent \< 16 years of age * Visiting pediatric ED * Presence of gastrointestinal symptom or symptoms (diarrhea, vomiting or abdominal pain)
Exclusion criteria
* Need of cardiopulmonary resuscitation at the ED * Need of immediate transfer to the intensive care unit * Hemato-oncological disease * Severe immunosuppression * Bloody diarrhea * Clinical suspicion of typhoid/paratyphoid fever
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on clinical decision making | 72 hours from initial contact at the ED | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of children needing hospitalization or specific follow up | 72 hours from initial contact at the ED | Proportion of children needing hospitalization or specific follow up |
| Time to receive the laboratory results | 7 days from the initial presentation to the ED | Time (hours) from the initial presentation at the ED to the laboratory results given to the clinicians |
| Length of stay | 30 days from the presentation to the ED | Length of hospital stay, time (hours) before discharge |
| Time to correct diagnosis | 30 days from the initial presentation at the ED | Time (hours) for the most probable correct diagnosis after the presentation at the ED |
| Time to resolution of symptoms | 28 days | The time (days) to the resolution of gastrointestinal symptoms based on medical record review and parental electronic survey at 2 weeks and 4 weeks after initial visit |
| The overall cost of diagnostic procedures | 72 hours from the initial contact | The cost (euros) per participant including all laboratory and radiological costs, adding the cost of multiplex PCR for the intervention group |
| Proportion of children with correctly targeted antimicrobial therapy | 72 hours from initial contact at the ED | Proportion of children with correctly targeted antimicrobial therapy based on PCR results |
| Need for a surgical consultation | 72 hours from initial presentation | The proportion of children needing a surgical consultation |
| Surgical operation | 72 hours from the initial presentation | The proportion of children undergoing abdominal surgery or operation |
| Revisit at the ED | 30 days | Proportion of participants with revisits to the ED |
| Correct hospital isolation measures | 72 hours from initial presentation | The proportion of children placed in a correct way in an infectious diseases ward due to a nosocomially problematic pathogen such as norovirus |
| Correct use of personal protective equipment | 72 hours from the initial presentation | The proportion of participants treated correctly using personal protective equipment based on multiplex PCR findings |
| Pediatric infectious diseases consultation | 72 hours after the initial presentation at the ED | The proportion of participants needing a pediatric infectious diseases consultation |
| Total cost of treatment | 30 days from the initial presentation | The total cost of treatment including hospital stay, and visits at ED |
Contacts
Primary ContactTerhi S Ruuska-Loewald, MD, PhD
Backup ContactJoni Kalermo, MD
Outcome results
None listed