Adenovirus Infection in Children With Autoimmune Hepatitis

NCT ID: NCT05693714

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2025-12-31

Brief Summary

Adenoviruses have been linked to severe hepatitis in children. They are non-enveloped, icosahedral viruses of medium size (90-100 nm) (5). Adenoviruses usually infect the respiratory tract, eyes, urinary tract, intestines, and central nervous system (6). These diseases are

Detailed Description

Hepatitis is an inflammatory reaction of the liver that lead to a spectrum of health problems (1). Hepatitis results from a variety of causes, both infectious and non-infectious. Infectious agents include viruses and parasites. Non-infectious causes include drugs and toxic agents (2).

Viral hepatitis remains an important challenge to human health, making it a leading cause of death globally. The absolute burden of viral hepatitis is increasing gradually (3).

The most common types of viral hepatitis are hepatitis A, B, and C. The other types are hepatitis D and E, which are less frequent (2). Epstein-Barr virus (EBV) and cytomegalovirus (CMV) infections are common and are associated with liver manifestations (4).

Adenoviruses have been linked to severe hepatitis in children. They are non-enveloped, icosahedral viruses of medium size (90-100 nm) (5). Adenoviruses usually infect the respiratory tract, eyes, urinary tract, intestines, and central nervous system (6). These diseases are generally self-limiting, but severe infections can occur in immunocompromised hosts (7). Children are more susceptible to HAdVs infection because their immune systems are less developed. HAdVs cause a range of symptoms, including colds, vomiting, diarrhea, and sometimes pneumonia, but rarely hepatitis in immunocompromised patients (8) In April 2022, the WHO has reported severe acute hepatitis outbreaks among children from 11 countries across Europe and America, which have induced great public concern, HAdV is presumed to be a possible etiology of this outbreak (9).

The diagnostic methods for adenovirus include antigen detection, polymerase chain reaction (PCR), virus isolation, and serology (10).

Conditions

Observational

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

One group who have adenovirus infection

Pcr

Intervention Type: DIAGNOSTIC_TEST

Polymerase chain reaction

Interventions

Pcr

Polymerase chain reaction

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Pcr(polymerase chain reaction)

Eligibility Criteria

Inclusion Criteria

• All children who are presented with symptoms suggestive of acute hepatitis like clinical jaundice, in the form of yellowish discoloration on sclera, fever, abdominal pain, diarrhea and raised liver enzymes between age group 2 years and 16 years.

Exclusion Criteria

• -All patients under 2 years old and above 16 years.
• History of drug intake which may affect liver functions

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Rana Refaat Abdelhafeez

Assiut lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rana Refaat

Role: CONTACT

14223863@med.aun.edu.eg

01016846749

Rana Refaat

Role: CONTACT

ranaarefat@gmail.com

01094494643

Other Identifiers

Adenovirus infection

Identifier Type: -

Identifier Source: org_study_id