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| Name | Class |
|---|---|
| Secretaria de Salud, Mexico | OTHER_GOV |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study will evaluate subjects with fever and/or rash to determine the percentage of those infected by the Zika, Chikungunya, or Dengue virus. The study will also compare the clinical signs, symptoms, and lab abnormalities related to each virus, to better specify each virus's characteristics.
The study will enroll subjects in several different cohorts including a febrile rash cohort (attempting to capture acute Zika/Chikungunya/Dengue infection), a household cohort (attempting to capture asymptomatic or minimally symptomatic subjects), and a cohort of those with Guillain Barré). Additionally, two subpopulations of the febrile rash cohort that have special follow up. This includes the pregnant population, who will be followed through delivery to determine pregnancy outcomes, and those subjects with neurologic or cognitive manifestations who will be evaluated to determine the spectrum of neurologic disease seen with these diseases.
Subjects with Guillain Barré with potential exposure to Zika virus are of special interest given the severity of disease. Subjects with Guillian Barré do not need to have a preceding illness suggestive of Zika or other viruses. As there are few subjects with Guillain Barré, subjects will be enrolled in two ways - a prospective cohort for subjects with acute Guillain Barré, and a cohort for subjects that had Guillain Barré in the last several years. Data collected systematically from these cohorts will improve the understanding of Zika/Chikungunya/Dengue virus infections.
There are many uncertainties about the number of subjects that meet this case definition. There are limits to the ability to enroll based on staffing and other resources. If there are many cases, an emphasis will be placed on enrolling pregnant subjects and adults with neurologic complications that meet the case definition, as this is the area of highest clinical need. If there are few pregnant women or subjects with neurologic problems that can be enrolled, then any adults or children meeting the criteria can be enrolled. Not all cohorts will be active at all sites, based on the type of facility and type of patients typically seen. If sufficient numbers of certain populations are enrolled (i.e. children born to women infected with Zika), the protocol may be amended to study those populations in more detail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febrile Rash | |||
| Household | |||
| Guillain-Barré prospective | |||
| Prior Guillain-Barré |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects that have confirmed Zika, Chikungunya, or Dengue (including co-infections) from the subjects presenting with fever and/or rash in southeastern Mexico. | 2 years |
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Febrile Rash Cohort Inclusion Criteria:
Subjects with fever and/or rash will be included if they are 1 year of age or older, and meet one of the following criteria (1 or 2):
Meeting the WHO/PAHO case definition, as defined as (a and b and c):
One or both of the following primary signs:
One or more of the following symptoms (not explained by other medical conditions):
Onset of illness in the last 7 days
Modified case definition (a and b):
Any two of the following:
Onset of illness in the last 7 days
Household Cohort Inclusion Criteria:
Guillain-Barré Prospective Cohort Inclusion Criteria:
Either confirmed or suspected Guillain-Barré (areflexic flaccid paralysis) as defined either of the following:
Confirmed Guillain-Barré
Suspected Guillain-Barré
Prior Guillain-Barré Cohort Inclusion Criteria:
Confirmed Guillain-Barré
Suspected Guillain-Barré
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The study will recruit male and female individuals of one year of age or older from southeastern Mexico and neighboring areas who exhibit signs of rash and/or fever that may be indicative Zika, Dengue, or Chikungunya. In addition, family members of these individuals will asked to be participate whether they have symptoms or not. Pregnant women will be included. Also, all individuals with a prior diagnosis of Guillain-Barré or history suggestive of Guillain-Barré will be asked to enroll.
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| Name | Affiliation | Role |
|---|---|---|
| Sophia Siddiqui | National Institute of Allergy and Infectious Diseases (NIAID) | Study Chair |
| Guillermo Ruiz-Palacios | Mexican Emerging Infectious Diseases Clinical Research Network | Study Chair |
| Pablo Francisco Belaunzarán Zamudio | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Tapachula | Tapachula | Chiapas | Mexico | |||
| Hospital Regional de Alta Especialidad Ciudad Salud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34454432 | Derived | Belaunzaran-Zamudio PF, Rincon Leon HA, Caballero Sosa S, Ruiz E, Najera Cancino JG, de La Rosa PR, Guerrero Almeida ML, Powers JH 3rd, Beigel JH, Hunsberger S, Trujillo K, Ramos P, Arteaga-Cabello FJ, Lopez-Roblero A, Valdes-Salgado R, Arroyo-Figueroa H, Becerril E, Ruiz-Palacios G; Mexican Emerging Infectious Diseases Clinical Research Network (La Red). Different epidemiological profiles in patients with Zika and dengue infection in Tapachula, Chiapas in Mexico (2016-2018): an observational, prospective cohort study. BMC Infect Dis. 2021 Aug 28;21(1):881. doi: 10.1186/s12879-021-06520-x. | |
| 33828518 |
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| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| D003715 | Dengue |
| D065632 | Chikungunya Fever |
| D020275 | Guillain-Barre Syndrome |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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Urine samples Blood samples
| Chiapas |
| Mexico |
| Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE) Clínica Hospital Dr. Roberto Nettel Flores | Chiapas | Mexico |
| Instituto Mexicano del Seguro Social (IMSS) Delegación Estatal / Hospital General de Zona con Medicina Familiar No. 1 | Chiapas | Mexico |
| Instituto Mexicano del Seguro Social (IMSS) Delegación Estatal / Unidad de Medicina Familiar No. 11 | Chiapas | Mexico |
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City | Mexico |
| Derived |
| Belaunzaran-Zamudio PF, Ortega-Villa AM, Mimenza-Alvarado AJ, Guerra-De-Blas PDC, Aguilar-Navarro SG, Sepulveda-Delgado J, Hunsberger S, Salgado RV, Ramos-Castaneda J, Rincon Leon HA, Rodriguez de La Rosa P, Najera Cancino JG, Beigel J, Caballero Sosa S, Ruiz Hernandez E, Powers JH 3rd, Ruiz-Palacios GM, Lane C. Comparison of the Impact of Zika and Dengue Virus Infection, and Other Acute Illnesses of Unidentified Origin on Cognitive Functions in a Prospective Cohort in Chiapas Mexico. Front Neurol. 2021 Mar 22;12:631801. doi: 10.3389/fneur.2021.631801. eCollection 2021. |
| 31672665 | Derived | Gouel-Cheron A, Lumbard K, Hunsberger S, Arteaga-Cabello FJ, Beigel J, Belaunzaran-Zamudio PF, Caballero-Sosa S, Escobedo-Lopez K, Ibarra-Gonzalez V, Najera-Cancino JG, Rincon-Leon HA, Ruiz-Hernandez E, Sepulveda-Delgado J, Trujillo-Murillo K, Ruiz-Palacios G. Serial real-time RT-PCR and serology measurements substantially improve Zika and Dengue virus infection classification in a co-circulation area. Antiviral Res. 2019 Dec;172:104638. doi: 10.1016/j.antiviral.2019.104638. Epub 2019 Oct 28. |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D018354 | Alphavirus Infections |
| D014036 | Togaviridae Infections |
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |