ObservationalNCT05693714
Adenovirus Infection in Children With Autoimmune Hepatitis
An observational study of Observational, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Observational
- What is being tested?
- Pcr
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cross sectional study
Who may be able to join
- 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.
Who cannot join
- -All patients under 2 years old and above 16 years.
- History of drug intake which may affect liver functions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevelance of Adenovirus in Children With Acute Hepatitis in Assiut University Hospital
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
Read the 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
- Being tested
- Pcr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PcrDiagnostic test
Also called Pcr(polymerase chain reaction)
Polymerase chain reaction
| Study group | Role | What they receive |
|---|---|---|
| 1 | One group who have adenovirus infection Receives: Diagnostic Test: Pcr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenovirus infection
Prevalence of adenovirus infection in children with autoimmune hepatitis
Measured: 2024
Adenovirus infection
Prevalence of adenovirus infection in children with autoimmune hepatitis
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start20 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObservationalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Refaat Abdelhafeez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693714
- Sponsor's protocol ID
- Adenovirus infection
- Status last verified
- Dec 2022
- First submitted
- 12 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Adenovirus in Children With Acute Hepatitis in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05693714
- Acronym / sponsor ID
- Adenovirus infection
- Conditions
- Observational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: PcrOne group who have adenovirus infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cross sectional study
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- -All patients under 2 years old and above 16 years.
- History of drug intake which may affect liver functions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PcrAlso: Pcr(polymerase chain reaction)Polymerase chain reaction | Diagnostic test | 1 |
Primary outcome
Adenovirus infection
Time frame: 2024
Prevalence of adenovirus infection in children with autoimmune hepatitis
Adenovirus infection
Time frame: 2025
Prevalence of adenovirus infection in children with autoimmune hepatitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
Related trials for Observational
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Refaat (01016846749, 14223863@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenovirus infection (time frame: 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.