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Neurologic Manifestations of the Arbovirus Infection in Colombia

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ClinicalTrials.gov Identifier: NCT03206541
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
Universidad del Valle, Colombia
ZikaPLAN
Information provided by (Responsible Party):
Johns Hopkins University

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.

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

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Neurovirus Emerging in the Americas Study (NEAS): Neurologic Manifestations of the Arbovirus Dengue, Chikungunya and Zika Infections in Colombia
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Group/Cohort
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.



Primary Outcome Measures :
  1. Neurological outcomes in arbovirus infections [ Time Frame: 12-24 months ]
    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


Secondary Outcome Measures :
  1. Viral genotype [ Time Frame: 24-36 months ]
    Number of strains of Zika, Dengue and Chikungunya viruses assessed by genome sequencing

  2. Immune response [ Time Frame: 24-36 months ]
    Cellular immune response assessed by T-lymphocyte profiling in patients with confirmed arbovirus infection with and without neurological syndromes


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.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206541


Contacts
Contact: Carlos A Pardo-Villamizar, MD 410-614-4548 cpardov1@jhmi.edu
Contact: Laura S Munoz-Arcos, MD 443-287-3703 lmunoza1@jhmi.edu

Locations
Colombia
Clinica Leon XIII Recruiting
Medellín, Antioquia, Colombia
Contact: Jorge A Jimenez-Arango, MD       jorge.neurologia@gmail.com   
Neuroclinica Recruiting
Medellín, Antioquia, Colombia
Contact: Jorge A Jimenez-Arango       jorge.neurologia@gmail.com   
Clinica La Misericordia Internacional Recruiting
Barranquilla, Atlantico, Colombia
Contact: Jose Vargas, MD       drjosevargasm@gmail.com   
Clinica Medilaser Recruiting
Neiva, Huila, Colombia
Contact: Jorge Angarita, MD       jorgeangarita@hotmail.com   
Hospital Universitario de Neiva Recruiting
Neiva, Huila, Colombia
Contact: Guillermo Gonzalez-Manrique, MD       feevon@hotmail.es   
Hospital Universitario de Narino Not yet recruiting
Pasto, Narino, Colombia
Contact: Julie Benavides, MSc       julie.benavidesm@campusucc.edu.co   
Hospital Universitario Erasmo Meoz Recruiting
Cúcuta, Norte de Santander, Colombia
Contact: Jairo Lizarazo, MD       jflizar@gmail.com   
Hospital Universitario del Valle Recruiting
Cali, Valle del Cauca, Colombia
Contact: Gonzalo Zuniga, MD       gonzuga28@hotmail.com   
Sub-Investigator: Andres F Zea, MD         
Sponsors and Collaborators
Johns Hopkins University
Universidad del Valle, Colombia
ZikaPLAN
Investigators
Principal Investigator: Carlos A Pardo-Villamizar, MD Johns Hopkins University
Principal Investigator: Beatriz Parra, PhD Universidad del Valle
Principal Investigator: Lyda Osorio, PhD Universidad del Valle

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
This data set contains detailed information on a cohort of 68 cases with Guillain-Barre syndrome that was analyzed as part of NEAS. The NEAS forms used to collect clinical information are available at the end of the document.

Publications of Results:
Other Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03206541     History of Changes
Other Study ID Numbers: IRB00093149
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NEAS is part of the ZikaPLAN, which is a consortium led by the European Community. There is a plan of sharing information with other collaborators within the consortium. The information will include demographic information, laboratory results and neurological physical exam. No identifiers will be shared. The information will be obtained through the ongoing recruitment of patients. We plan to share the first set of information during the second semester of 2017.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Neurological syndromes
Arbovirus infection

Additional relevant MeSH terms:
Dengue
Infection
Communicable Diseases
Fever
Virus Diseases
Meningitis
Encephalitis
Chikungunya Fever
Neurologic Manifestations
Myelitis
Guillain-Barre Syndrome
Zika Virus Infection
Arbovirus Infections
Cranial Nerve Diseases
Body Temperature Changes
Signs and Symptoms
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases
Alphavirus Infections
Togaviridae Infections
Central Nervous System Infections
Spinal Cord Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases