Gastroenteritis AcuteRealCAGI RCTNCT07280624
Diagnostic PCR Panel in Children With Acute Gastrointestinal Symptoms
A study testing Multiplex PCR gastrointestinal panel in people with Gastroenteritis Acute and Gastrointestinal Symptoms, run by University of Oulu.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Gastroenteritis Acute, Gastrointestinal Symptoms, Abdominal Pain/ Discomfort
- What is being tested?
- Multiplex PCR gastrointestinal panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child or adolescent < 16 years of age
- Visiting pediatric ED
- Presence of gastrointestinal symptom or symptoms (diarrhea, vomiting or abdominal pain)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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:
- 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
- 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.
- Conditions
- Gastroenteritis Acute, Gastrointestinal Symptoms, Abdominal Pain/ Discomfort, Vomiting in Infants and/or Children
- Being tested
- Multiplex PCR gastrointestinal panel
- Keywords
- Multiplex PCR, Fecal samples, Diagnostic stewardship, Diarrhea, Vomiting, Abdominal pain, Gastrointestinal symptoms, Pediatrics, Children, Emergency department
- Medical subject headings
- Diarrhea, Vomiting, Abdominal Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex PCR gastrointestinal panelDiagnostic test
Also called Multiplex PCR of 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Rapid diagnostics group | Other | Immediate use of multiplex PCR panel for fecal samples Receives: Diagnostic Test: Multiplex PCR gastrointestinal panel |
| Control group | No intervention | Control group without immediate multiplex PCR for fecal samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours from initial contact at the ED
Secondary outcomes (14)
Proportion of children with correctly targeted antimicrobial therapy
Proportion of children with correctly targeted antimicrobial therapy based on PCR results
Measured: 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
Measured: 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
Measured: 7 days from the initial presentation to the ED
Length of stay
Length of hospital stay, time (hours) before discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours from the initial contact
Total cost of treatment
The total cost of treatment including hospital stay, and visits at ED
Measured: 30 days from the initial presentation
Need for a surgical consultation
The proportion of children needing a surgical consultation
Measured: 72 hours from initial presentation
Surgical operation
The proportion of children undergoing abdominal surgery or operation
Measured: 72 hours from the initial presentation
Revisit at the ED
Proportion of participants with revisits to the ED
Measured: 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
Measured: 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
Measured: 72 hours from the initial presentation
Pediatric infectious diseases consultation
The proportion of participants needing a pediatric infectious diseases consultation
Measured: 72 hours after the initial presentation at the ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroenteritis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Terhi S Ruuska-Loewald, MD, PhD, Principal investigator, Oulu University Hospital and University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280624
- Sponsor's protocol ID
- OULU_EETTMK_39_2025
- Acronym
- RealCAGI RCT
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 34448253Freeman 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.
PubMed 28619124
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Real Time PCR Panel in Children With Acute Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT07280624
- Acronym / sponsor ID
- RealCAGI RCT / OULU_EETTMK_39_2025
- Conditions
- Gastroenteritis Acute, Gastrointestinal Symptoms, Abdominal Pain/ Discomfort, Vomiting in Infants and/or Children
- Keywords
- Multiplex PCR, Fecal samples, Diagnostic stewardship, Diarrhea, Vomiting, Abdominal pain, Gastrointestinal symptoms, Pediatrics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Rapid diagnostics group | Other | Diagnostic Test: Multiplex PCR gastrointestinal panelImmediate use of multiplex PCR panel for fecal samples |
| Control group | No intervention | –Control group without immediate multiplex PCR for fecal samples |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child or adolescent < 16 years of age
- Visiting pediatric ED
- Presence of gastrointestinal symptom or symptoms (diarrhea, vomiting or abdominal pain)
Key exclusion criteria (6 listed)
- Need of cardiopulmonary resuscitation at the ED
- Need of immediate transfer to the intensive care unit
- Hemato-oncological disease
- Severe immunosuppression
- Bloody diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplex PCR gastrointestinal panelAlso: Multiplex PCR of fecal samplesIntervention 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 | Diagnostic test | Intervention: Rapid diagnostics group |
Primary outcome
Impact on clinical decision making
Time frame: 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
14 secondary outcomes
Proportion of children with correctly targeted antimicrobial therapy
Time frame: 72 hours from initial contact at the ED
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 frame: 7 days from the initial presentation to the ED
Length of stay
Time frame: 30 days from the presentation to the ED
Time to correct diagnosis
Time frame: 30 days from the initial presentation at the ED
Time to resolution of symptoms
Time frame: 28 days
The overall cost of diagnostic procedures
Time frame: 72 hours from the initial contact
Total cost of treatment
Time frame: 30 days from the initial presentation
Need for a surgical consultation
Time frame: 72 hours from initial presentation
Surgical operation
Time frame: 72 hours from the initial presentation
Revisit at the ED
Time frame: 30 days
Correct hospital isolation measures
Time frame: 72 hours from initial presentation
Correct use of personal protective equipment
Time frame: 72 hours from the initial presentation
Pediatric infectious diseases consultation
Time frame: 72 hours after the initial presentation at the ED
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 34448253Poyry 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.
- Background: PubMed 28619124Freeman 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terhi S Ruuska-Loewald, MD, PhD principal investigator
Oulu University Hospital and University of Oulu
Questions about this trial
What is this clinical trial studying?
A study testing Multiplex PCR gastrointestinal panel in people with Gastroenteritis Acute and Gastrointestinal Symptoms, run by University of Oulu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Terhi S Ruuska-Loewald, MD, PhD (+358 40 70 546 77, terhi.ruuska-loewald@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on clinical decision making (time frame: 72 hours from initial contact at the ED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07280624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.