Diagnostic PCR Panel in Children With Acute Gastrointestinal Symptoms

NCT07280624 | Not Yet Recruiting

• 1 other identifier: OULU_EETTMK_39_2025
• Study Type: interventional
• Target: 526
• Locations: 0 countries
• Sites: N/A

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.

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; Children; Emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Proportion of children with correctly targeted antimicrobial therapy

  72 hours from initial contact at the ED

• Proportion of children needing hospitalization or specific follow up

  72 hours from initial contact at the ED

• Time to receive the laboratory results

  7 days from the initial presentation to the ED

• Length of stay

  30 days from the presentation to the ED

• Time to correct diagnosis

  30 days from the initial presentation at the ED

Study Arms (2)

Intervention: Rapid diagnostics group

OTHER

Immediate use of multiplex PCR panel for fecal samples

Diagnostic Test: Multiplex PCR gastrointestinal panel

Control group

NO INTERVENTION

Control group without immediate multiplex PCR for fecal samples

Interventions

Multiplex PCR gastrointestinal panel DIAGNOSTIC_TEST

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

Intervention: Rapid diagnostics group

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child or adolescent \< 16 years of age
• Visiting pediatric ED
• Presence of gastrointestinal symptom or symptoms (diarrhea, vomiting or abdominal pain)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oulu University Hospital: collaborator
• University of Oulu: lead

Related Publications (2)

• 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.

  PMID: 34448253 BACKGROUND

• 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.

  PMID: 28619124 BACKGROUND

MeSH Terms

Conditions

Diarrhea; Vomiting; Abdominal Pain; Emergencies

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Disease Attributes; Pathologic Processes

Study Officials

• Terhi S Ruuska-Loewald, MD, PhD

  Oulu University Hospital and University of Oulu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terhi S Ruuska-Loewald, MD, PhD

CONTACT

+358 40 70 546 77; terhi.ruuska-loewald@oulu.fi

Joni Kalermo, MD

CONTACT

+358 8 315 5260; joni.kalermo@student.oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 12, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon the submission of the manuscript