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Adenovirus Infection in Children With Autoimmune Hepatitis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05693714
Collaborator
(none)
76
Enrollment
35.4
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Pcr

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
76 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Prevelance of Adenovirus in Children With Acute Hepatitis in Assiut University Hospital
Anticipated Study Start Date :
Jan 20, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
1

One group who have adenovirus infection

Diagnostic Test: Pcr
Polymerase chain reaction
Other Names:
  • Pcr(polymerase chain reaction)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adenovirus infection [2024]

      Prevalence of adenovirus infection in children with autoimmune hepatitis

    2. Adenovirus infection [2025]

      Prevalence of adenovirus infection in children with autoimmune hepatitis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rana Refaat Abdelhafeez, Assiut lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05693714
    Other Study ID Numbers:
    • Adenovirus infection
    First Posted:
    Jan 23, 2023
    Last Update Posted:
    Jan 23, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Hepatitis

    Study Results

    No Results Posted as of Jan 23, 2023