Diagnostic PCR Panel in Children With Acute Gastrointestinal Symptoms (RealCAGI RCT)

Clinical Significance of Real Time PCR Panel in Children With Acute Gastrointestinal Symptoms

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastroenteritis Acute; Gastrointestinal Symptoms; Vomiting in Infants and/or Children; Abdominal Pain/ Discomfort
• Intervention / Treatment: Diagnostic test: Multiplex PCR gastrointestinal panel

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.

• Study Type: Interventional
• Enrollment (Estimated): 526
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Terhi S Ruuska-Loewald, MD, PhD; Phone Number: +358 40 70 546 77; Email: terhi.ruuska-loewald@oulu.fi
• Study Contact Backup: Name: Joni Kalermo, MD; Phone Number: +358 8 315 5260; Email: joni.kalermo@student.oulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention: Rapid diagnostics group; Immediate use of multiplex PCR panel for fecal samples	Diagnostic test: Multiplex 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; Other Names: Multiplex PCR of fecal samples
No Intervention: Control group; Control group without immediate multiplex PCR for fecal samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 hours from initial contact at the ED

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children with correctly targeted antimicrobial therapy	Proportion of children with correctly targeted antimicrobial therapy based on PCR results	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	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	7 days from the initial presentation to the ED
Length of stay	Length of hospital stay, time (hours) before discharge	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	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	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	72 hours from the initial contact
Total cost of treatment	The total cost of treatment including hospital stay, and visits at ED	30 days from the initial presentation
Need for a surgical consultation	The proportion of children needing a surgical consultation	72 hours from initial presentation
Surgical operation	The proportion of children undergoing abdominal surgery or operation	72 hours from the initial presentation
Revisit at the ED	Proportion of participants with revisits to the ED	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	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	72 hours from the initial presentation
Pediatric infectious diseases consultation	The proportion of participants needing a pediatric infectious diseases consultation	72 hours after the initial presentation at the ED

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital
• Investigators: Principal Investigator: Terhi S Ruuska-Loewald, MD, PhD, Oulu University Hospital and University of Oulu

Publications and helpful links

General Publications

• Poyry H, Kiviniemi M, Raappana A, Honkila M, Paalanne N, Pokka T, Valmari P, Renko M, Tapiainen T. The most common diagnoses and costs of paediatric emergency department visits: A population-based cohort study. Acta Paediatr. 2022 Jan;111(1):169-170. doi: 10.1111/apa.16087. Epub 2021 Sep 20. No abstract available.
• Freeman K, Mistry H, Tsertsvadze A, Royle P, McCarthy N, Taylor-Phillips S, Manuel R, Mason J. Multiplex tests to identify gastrointestinal bacteria, viruses and parasites in people with suspected infectious gastroenteritis: a systematic review and economic analysis. Health Technol Assess. 2017 Apr;21(23):1-188. doi: 10.3310/hta21230.

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): February 15, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Diarrhea; Children; Vomiting; Pediatrics; Emergency department; Abdominal pain; Gastrointestinal symptoms; Multiplex PCR; Diagnostic stewardship; Fecal samples
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Abdominal Pain; Emergencies; Vomiting; Diarrhea
• Other Study ID Numbers: OULU_EETTMK_39_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Upon the submission of the manuscript
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No