Meningitis Clinical Trial
Official title:
Neurovirus Emerging in the Americas Study (NEAS): Neurologic Manifestations of the Arbovirus Dengue, Chikungunya and Zika Infections in Colombia
Verified date | February 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is a multi-center case-control study that aims to define the association between the exposure to an arbovirus infection and the development of a neurological syndrome in patients from Colombia. The study makes part of the Neurovirus Emerging in the Americas Study (NEAS) that is a collaborative effort that looks to combine the efforts of researchers, healthcare providers and patients in Colombia to establish a comprehensive registry of the clinical, radiological and laboratory profile of patients with new onset of neurological diseases associated mosquito-borne viruses, known as arboviruses.
Status | Completed |
Enrollment | 570 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years and older |
Eligibility |
Inclusion Criteria: - Male or female - Case or control definition - Informed consent or assent Exclusion Criteria: - Known etiology for the acute neurological disorders - History of known neurological syndrome |
Country | Name | City | State |
---|---|---|---|
Colombia | Clinica La Misericordia Internacional | Barranquilla | Atlantico |
Colombia | Hospital Universitario del Valle | Cali | Valle Del Cauca |
Colombia | Hospital Universitario Erasmo Meoz | Cúcuta | Norte De Santander |
Colombia | Clinica Leon XIII | Medellín | Antioquia |
Colombia | Neuroclinica | Medellín | Antioquia |
Colombia | Clinica Medilaser | Neiva | Huila |
Colombia | Hospital Universitario de Neiva | Neiva | Huila |
Colombia | Hospital Universitario de Narino | Pasto | Narino |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Universidad del Valle, Colombia, ZikaPLAN |
Colombia,
Muñoz LS, Barreras P, Pardo CA. Zika Virus-Associated Neurological Disease in the Adult: Guillain-Barré Syndrome, Encephalitis, and Myelitis. Semin Reprod Med. 2016 Sep;34(5):273-279. Epub 2016 Sep 9. Review. — View Citation
Parra B, Lizarazo J, Jiménez-Arango JA, Zea-Vera AF, González-Manrique G, Vargas J, Angarita JA, Zuñiga G, Lopez-Gonzalez R, Beltran CL, Rizcala KH, Morales MT, Pacheco O, Ospina ML, Kumar A, Cornblath DR, Muñoz LS, Osorio L, Barreras P, Pardo CA. Guillai — View Citation
Rowland A, Washington CI, Sheffield JS, Pardo-Villamizar CA, Segars JH. Zika virus infection in semen: a call to action and research. J Assist Reprod Genet. 2016 Apr;33(4):435-7. doi: 10.1007/s10815-016-0684-6. Epub 2016 Mar 5. — View Citation
Zea-Vera AF, Parra B. Zika virus (ZIKV) infection related with immune thrombocytopenic purpura (ITP) exacerbation and antinuclear antibody positivity. Lupus. 2017 Jul;26(8):890-892. doi: 10.1177/0961203316671816. Epub 2016 Sep 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurological outcomes in arbovirus infections | Number of patients with neurological syndromes that have evidence of acute infection by Zika, Dengue or Chikungunya viruses assessed by IgM serology or polymerase chain reaction | 12-24 months | |
Secondary | Viral genotype | Number of strains of Zika, Dengue and Chikungunya viruses assessed by genome sequencing | 24-36 months | |
Secondary | Immune response | Cellular immune response assessed by T-lymphocyte profiling in patients with confirmed arbovirus infection with and without neurological syndromes | 24-36 months |
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