An interventional study of Multiplex PCR gastrointestinal panel in Gastroenteritis Acute, Gastrointestinal Symptoms and Abdominal Pain/ Discomfort, sponsored by University of Oulu. Not yet recruiting. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by University of Oulu · Not applicable, Interventional, and Diagnostic
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.
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:
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 526 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immediate use of multiplex PCR panel for fecal samples
Diagnostic Test: Multiplex PCR gastrointestinal panel
Control group without immediate multiplex PCR for fecal samples
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
Also known as: Multiplex PCR of fecal samples
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
Time frame: 72 hours from initial contact at the ED
Proportion of children with correctly targeted antimicrobial therapy
Proportion of children with correctly targeted antimicrobial therapy based on PCR results
Time frame: 72 hours from initial contact at the ED
Proportion of children needing hospitalization or specific follow up
Proportion of children needing hospitalization or specific follow up
Time frame: 72 hours from initial contact at the ED
Time to receive the laboratory results
Time (hours) from the initial presentation at the ED to the laboratory results given to the clinicians
Time frame: 7 days from the initial presentation to the ED
Length of stay
Length of hospital stay, time (hours) before discharge
Time frame: 30 days from the presentation to the ED
Time to correct diagnosis
Time (hours) for the most probable correct diagnosis after the presentation at the ED
Time frame: 30 days from the initial presentation at the ED
Time to resolution of symptoms
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
Time frame: 28 days
The overall cost of diagnostic procedures
The cost (euros) per participant including all laboratory and radiological costs, adding the cost of multiplex PCR for the intervention group
Time frame: 72 hours from the initial contact
Total cost of treatment
The total cost of treatment including hospital stay, and visits at ED
Time frame: 30 days from the initial presentation
Need for a surgical consultation
The proportion of children needing a surgical consultation
Time frame: 72 hours from initial presentation
Surgical operation
The proportion of children undergoing abdominal surgery or operation
Time frame: 72 hours from the initial presentation
Revisit at the ED
Proportion of participants with revisits to the ED
Time frame: 30 days
Correct hospital isolation measures
The proportion of children placed in a correct way in an infectious diseases ward due to a nosocomially problematic pathogen such as norovirus
Time frame: 72 hours from initial presentation
Correct use of personal protective equipment
The proportion of participants treated correctly using personal protective equipment based on multiplex PCR findings
Time frame: 72 hours from the initial presentation
Pediatric infectious diseases consultation
The proportion of participants needing a pediatric infectious diseases consultation
Time frame: 72 hours after the initial presentation at the ED
No study locations are listed for this record.
Plan to share: Yes — The individual participant data on the primary outcome of participants according to groups. No identifying participant data will be shared according to EU GDPR regulations. Study protocol and statistical analysis plan will be hared upon submission of the manuscript.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Upon the submission of the manuscript
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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