Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis

Sponsor

Medical University of Warsaw (Other)

Overall Status

Recruiting

CT.gov ID

NCT05270291

Collaborator

(none)

198

Enrollment

Location

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In children with acute gastroenteritis (AGE), vomiting often precedes diarrhea. To establish the diagnosis of AGE, enteropathogen detection typically relies on diarrheal stool samples. However, testing requires sufficient stool sample, which may not be easily available. Recent studies suggest that in children presenting to emergency departments with presumed AGE with isolated vomiting, an enteropathogen can be identified using rectal swabs and molecular diagnostic tests. The rate of enteropathogen detection in children with isolated vomiting due to AGE may differ in various populations. Using rectal swabs and molecular diagnostic tests, we plan to assess the proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.

This will be a prospective cohort study. Children younger than 5 years with presence of ≥3 episodes of vomiting due to presumed AGE, lasting no longer than 7 days before enrolment, will be recruited. A total of 198 participants will be recruited and a rectal swab will be collected. The participants will be contacted 14 days after enrollment to complete a survey regarding symptoms experienced during that period and to identify any additional clinical care.

Condition or Disease	Intervention/Treatment	Phase
Acute Gastroenteritis Vomiting	Procedure: rectal swab

Study Design

Study Type:

Observational

Anticipated Enrollment :

198 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis in the Absence of Diarrhea

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified. [immediately after the procedure]

Secondary Outcome Measures

Types of pathogens detected based on presenting symptoms [immediately after the procedure]
The proportion of children with isolated vomiting with alternative diagnosis [immediately after procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age 0-5-year-old
presence of ≥3 episodes of vomiting due to presumed AGE at inclusion
<7 days of symptoms at the time of inclusion
signed written informed consent

Exclusion Criteria:

anticipated inability to complete 14 days follow-up
history of neutropenia (as rectal swabs are contraindicated)
critically ill status requiring urgent medical intervention
inability to provide a rectal swab for testing
chronic gastrointestinal tract disorders such as inflammatory bowel disease, cystic fibrosis, coeliac disease
immunodeficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Warsaw	Warsaw	Mazovian	Poland	02-091

Sponsors and Collaborators

Medical University of Warsaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanna Szajewska, Profesor, Medical University of Warsaw

ClinicalTrials.gov Identifier:

NCT05270291

Other Study ID Numbers:

Isolated vomiting etiology

First Posted:

Mar 8, 2022

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hanna Szajewska, Profesor, Medical University of Warsaw

acute gastroenteritis

children

vomiting

enteropathogens

Additional relevant MeSH terms:

Gastroenteritis

Vomiting

Study Results

No Results Posted as of Jun 28, 2022