Neurologic Manifestations of the Arbovirus Infection in Colombia

NCT03206541 | Completed

• 1 other identifier: IRB00093149
• Study Type: observational
• Target: 570
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Encephalitis; Myelitis; Guillain-Barre Syndrome; Cranial Nerve Palsies; Meningitis; Zika Virus Infection; Dengue (Virus); Fever, Sandfly; Chikungunya Fever

Keywords

Neurological syndromes; Arbovirus infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Viral genotype

  24-36 months

• Immune response

  24-36 months

Study Arms (2)

Cases

The cases are defined as individuals that present with new onset of a neurological syndrome of unknown etiology, including but not limited to encephalitis, myelitis, meningitis, polyneuropathy/Guillain-Barre syndrome and cranial nerve involvement.

Controls

There are two age-matched control groups: 1. Household controls that have lived with the case for at least three months before the onset of neurological symptoms. 2. Controls with a febrile syndrome of unknown etiology that do not present neurological involvement and is recruited in the same center as the case.

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes males and females over 8 years of age at risk of being infected by Dengue, Chikungunya or Zika viruses.

You may qualify if:

• Male or female
• Case or control definition
• Informed consent or assent

You may not qualify if:

• Known etiology for the acute neurological disorders
• History of known neurological syndrome

Sponsors & Collaborators

• Johns Hopkins University: lead
• Universidad del Valle, Colombia: collaborator
• ZikaPLAN: collaborator

Study Sites (8)

Clinica Leon XIII

Medellín, Antioquia, Colombia

Location

Neuroclinica

Medellín, Antioquia, Colombia

Location

Clinica La Misericordia Internacional

Barranquilla, Atlántico, Colombia

Location

Hospital Universitario de Narino

Pasto, Departamento de Nariño, Colombia

Location

Clinica Medilaser

Neiva, Huila Department, Colombia

Location

Hospital Universitario de Neiva

Neiva, Huila Department, Colombia

Location

Hospital Universitario Erasmo Meoz

Cúcuta, Norte de Santander Department, Colombia

Location

Hospital Universitario del Valle

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (4)

• Munoz LS, Barreras P, Pardo CA. Zika Virus-Associated Neurological Disease in the Adult: Guillain-Barre Syndrome, Encephalitis, and Myelitis. Semin Reprod Med. 2016 Sep;34(5):273-279. doi: 10.1055/s-0036-1592066. Epub 2016 Sep 9.

  PMID: 27612158 BACKGROUND

• 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. No abstract available.

  PMID: 26945753 BACKGROUND

• Parra B, Lizarazo J, Jimenez-Arango JA, Zea-Vera AF, Gonzalez-Manrique G, Vargas J, Angarita JA, Zuniga G, Lopez-Gonzalez R, Beltran CL, Rizcala KH, Morales MT, Pacheco O, Ospina ML, Kumar A, Cornblath DR, Munoz LS, Osorio L, Barreras P, Pardo CA. Guillain-Barre Syndrome Associated with Zika Virus Infection in Colombia. N Engl J Med. 2016 Oct 20;375(16):1513-1523. doi: 10.1056/NEJMoa1605564. Epub 2016 Oct 5.

  PMID: 27705091 RESULT

• 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.

  PMID: 27694629 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The study will retain blood (serum and plasma), urine, spinal fluid and saliva for cases and controls according to the protocol. The samples will remain in the core laboratory at UV and some of them will be shared with the JHU team.

MeSH Terms

Conditions

Encephalitis; Myelitis; Guillain-Barre Syndrome; Cranial Nerve Diseases; Meningitis; Zika Virus Infection; Dengue; Virus Diseases; Fever; Chikungunya Fever; Arbovirus Infections

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Central Nervous System Infections; Infections; Spinal Cord Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mosquito-Borne Diseases; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Body Temperature Changes; Signs and Symptoms; Alphavirus Infections; Togaviridae Infections

Study Officials

• Carlos A Pardo-Villamizar, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Beatriz Parra, PhD

  Universidad del Valle

  PRINCIPAL INVESTIGATOR

• Lyda Osorio, PhD

  Universidad del Valle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: July 2, 2017
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

CO (8)