The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico
Zik01
1 other identifier
observational
600
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2016
CompletedFirst Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2019
CompletedDecember 17, 2020
December 1, 2020
2.6 years
July 11, 2016
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Febrile Rash
Household
Guillain-Barré prospective
Prior Guillain-Barré
Eligibility Criteria
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.
You may qualify if:
- 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:
- Rash
- Elevated body temperature (\> 37.2 °C) AND
- One or more of the following symptoms (not explained by other medical conditions):
- Arthralgia
- Myalgia
- Non-purulent conjunctivitis or conjunctival hyperemia
- Headache
- Malaise AND
- Onset of illness in the last 7 days
- Modified case definition (a and b):
- Any two of the following:
- Rash
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital General de Tapachula
Tapachula, Chiapas, Mexico
Hospital Regional de Alta Especialidad Ciudad Salud
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
Related Publications (3)
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.
PMID: 34454432DERIVEDBelaunzaran-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.
PMID: 33828518DERIVEDGouel-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.
PMID: 31672665DERIVED
Biospecimen
Urine samples Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2016
First Posted
July 13, 2016
Study Start
June 21, 2016
Primary Completion
January 25, 2019
Study Completion
January 25, 2019
Last Updated
December 17, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share