The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico (Zik01)
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|ClinicalTrials.gov Identifier: NCT02831699|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 2, 2019
|Condition or disease|
|Zika Virus Disease (Disorder) Dengue Chikungunya|
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.
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Official Title:||The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico (Zik01)|
|Actual Study Start Date :||June 21, 2016|
|Actual Primary Completion Date :||January 25, 2019|
|Actual Study Completion Date :||January 25, 2019|
- 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. [ Time Frame: 2 years ]
Biospecimen Retention: Samples Without DNA
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): NCT02831699
|Hospital General de Tapachula|
|Tapachula, Chiapas, Mexico|
|Hospital Regional de Alta Especialidad Ciudad Salud|
|Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE) Clínica Hospital Dr. Roberto Nettel Flores|
|Instituto Mexicano del Seguro Social (IMSS) Delegación Estatal / Hospital General de Zona con Medicina Familiar No. 1|
|Instituto Mexicano del Seguro Social (IMSS) Delegación Estatal / Unidad de Medicina Familiar No. 11|
|Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán|
|Ciudad de México, Mexico|
|Study Chair:||Sophia Siddiqui||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Chair:||Guillermo Ruiz-Palacios||Mexican Emerging Infectious Diseases Clinical Research Network|
|Principal Investigator:||Pablo Francisco Belaunzarán Zamudio||Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|