Enterovirus D68 Clinical Trial
Official title:
A Clinical Observational Follow-up Study of European Pediatric Cases of Acute Flaccid Myelitis Associated With EV-D68 Infection.
NCT number | NCT03499366 |
Other study ID # | 2017/2123 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 9, 2018 |
Est. completion date | May 1, 2020 |
The study is a follow-up study on children with acute flaccid paresis associated with enterovirus D68 infection. Only children living in Europe are eligible. The study aim is to clarify the outcome of the disease and investigate possible clinical correlation with outcome, including initial severity, demographic characteristics, treatment and MRI findings.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 1, 2020 |
Est. primary completion date | April 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Acute flaccid paresis (AFP) at onset, and - Enterovirus D-68 polymerase chain reaction (PCR) positive in any specimen in a timely sample (+/- 3 weeks from onset of paresis), and - Age <18 years at onset, and - Magnetic resonance imaging (MRI) of spine and brain at onset with signs of myelitis. Exclusion Criteria: - Major trauma - central nervous system (CNS) malignancy - Bleeding or infarctions in CNS - Previous demyelinating disease - Other infections cause of myelitis is more likely - Patient and/or legal guardian is not able/willing to sign the consent form |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | National Health Service, United Kingdom, University Medical Center Groningen |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Hammersmith Functional Motor scale- score at follow-up | O'Hagen, J. M., et al. (2007). "An expanded version of the Hammersmith Functional Motor Scale for SMA II and III patients." Neuromuscul Disord 17(9-10): 693-697.Neurol. 2003;7(4):155-9. The scale is a 33 items evaluation (0, 1 or 2 points in each item) and results in an overall functional score. Range: 0-66, with a higher score reflecting better performance. No sub-scores will be used. |
1 year |