Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis

Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270291
• Other study ID #: Isolated vomiting etiology
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: June 2022
• Source: Medical University of Warsaw
• Contact: Aleksandra Cepinska, MD
• Phone: 223179444
• Email: ocepinska[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis
• Vomiting

Intervention

Procedure:
• rectal swab
rectal swab

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified.		immediately after the procedure
Secondary	Types of pathogens detected based on presenting symptoms		immediately after the procedure
Secondary	The proportion of children with isolated vomiting with alternative diagnosis		immediately after procedure