To estimate the frequency/ prevalence of acute or active HEV infection in patients presenting with (sub)acute post-infectious and/or immune-mediated neurological illness like neuralgic amyotrophy, (idiopathic) Guillain Barre syndrome, idiopathic…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of HEV positive neurological patients (HEV PCR positive and/or IgM
positive.
Secondary outcome
To describe in detail the phenotypes of neurological illness of patients with a
recent HEV infection.
Background summary
Hepatitis E virus genotype 1 and 2 infections are hyperendemic in Africa and
South-east Asia. The virus is transmitted via the fecal-oral route. Mortality
is high in pregnant women. A recent study form Bangladesh concludes to a
mortalty rate of 10%. The incidence of hepatitis E infections is increasing
dramatically in Canada, USA, Europe, New Zealand and Japan. In the developed
world HEV infection is caused by locally acquired genotype 3 which is a
zoonotic with a porcine primary host in contrast to genotype 1 and 2 with a
human host. Our understanding of the clinical range of HEV infection in humans
has undergone a sea-change in recent years, and expands. There is a growing
number of case-reports and case series with respect to the subject. Mainly
neurological disorders like GBS, neuralgic amyotrophy, encephalitis, Bell*s
palsy, transverse myelitis and peripheral neuropathies have been associated
with HEV. In many case-reports of HEV-associated neurological injury the
neurological symptoms and signs dominate the clinical picture and not the
hepatitis. Patients are usual anicteric and liverfunctions are only mildly to
modestly abnormal. In routine clinical practice such patients are unlikely to
be tested for HEV. Thus, the full range of HEV-associated neurological injury
is unknown, and pathogenic mechanisms are uncertain.
Study objective
To estimate the frequency/ prevalence of acute or active HEV infection in
patients presenting with (sub)acute post-infectious and/or immune-mediated
neurological illness like neuralgic amyotrophy, (idiopathic) Guillain Barre
syndrome, idiopathic facial nerve palsy (Bell*s palsy), vestibular neuritis,
optic neuritis, transverse myelitis, non-infectious encephalitis, and patients
with acute ischemic stroke.
Study design
This is an observational cohort pilot study of subjects over 18 years of age
presenting at the Jeroen Bosch Hospital,*s-Hertogenbosch with (sub)acute
post-infectious and/or immune-mediated neurological illness or acute ischemic
stroke. If the patiënt gives informed consent an ELISA (Wantai, Beijing, PR
China) will be performed to detect IgM and IgG antibodies to HEV. Additionally
a validated quantative RT-PCR will be done.
Study burden and risks
Patients consent to give one blood sample (10 ml) in the far majority if not
in all patients during an already planned venapunction. There is a very small
chance of local hematoma due to venapunction without further risks.
Henri Dunantstraat 1 Henri Dunantstraat 1
's-Hertogenbosch 5223 GZ
NL
Henri Dunantstraat 1 Henri Dunantstraat 1
's-Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
Participant is willing and able to give informed consent for participation in the study.
Male or Female, aged 18 years or above.
Diagnosed with an (sub)acute post-infectious/ immune-mediated neurological disorder or ischemic stroke
Participants will have blood drawn for standard clinical care.
Exclusion criteria
-Not willing and able to give informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL52981.028.15 |