- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05693714
Adenovirus Infection in Children With Autoimmune Hepatitis
Prevelance of Adenovirus in Children With Acute Hepatitis in Assiut University Hospital
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rana Refaat
- Phone Number: 01016846749
- Email: 14223863@med.aun.edu.eg
Study Contact Backup
- Name: Rana Refaat
- Phone Number: 01094494643
- Email: ranaarefat@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
One group who have adenovirus infection
|
Polymerase chain reaction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adenovirus infection
Time Frame: 2024
|
Prevalence of adenovirus infection in children with autoimmune hepatitis
|
2024
|
|
Adenovirus infection
Time Frame: 2025
|
Prevalence of adenovirus infection in children with autoimmune hepatitis
|
2025
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adenovirus infection
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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