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The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico (Zik01)

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ClinicalTrials.gov Identifier: NCT02831699
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
Secretaria de Salud, Mexico
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Mexican Emerging Infectious Diseases Clinical Research Network

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.

Condition or disease
Zika Virus Disease (Disorder) Dengue Chikungunya

Detailed Description:

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
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico (Zik01)
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


Group/Cohort
Febrile Rash
Household
Guillain-Barré prospective
Prior Guillain-Barré



Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Urine samples Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will recruit male and female individuals of any age 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.
Criteria

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):

  1. Meeting the WHO/PAHO case definition, as defined as (a and b and c):

    1. One or both of the following primary signs:

      • Rash
      • Elevated body temperature (> 37.2 °C) AND
    2. One or more of the following symptoms (not explained by other medical conditions):

      • Arthralgia
      • Myalgia
      • Non-purulent conjunctivitis or conjunctival hyperemia
      • Headache
      • Malaise AND
    3. Onset of illness in the last 7 days
  2. Modified case definition (a and b):

    1. Any two of the following:

      • Rash
      • Elevated body temperature (> 37.2 °C)
      • Arthralgia
      • Myalgia
      • Non-purulent conjunctivitis or conjunctival hyperemia
      • Headache
      • Malaise AND
    2. Onset of illness in the last 7 days

Household Cohort Inclusion Criteria:

  1. 1 year of age and older, and
  2. Either live in the same household as a subject enrolled into the febrile rash cohort OR live in the same household as a subject who is experiencing an illness similar to Zika (fever and rash as previously described), regardless if said subject is enrolled in the study.

Guillain-Barré Prospective Cohort Inclusion Criteria:

Either confirmed or suspected Guillain-Barré (areflexic flaccid paralysis) as defined either of the following:

  1. Confirmed Guillain-Barré

    1. Acute onset of weakness or paralysis (from baseline to full weakness in 7 days)
    2. Weakness is symmetrical
    3. Areflexic (reflexes are 0/4)
    4. Diagnosis within the last 10 days
  2. Suspected Guillain-Barré

    1. Acute onset of illness
    2. Areflexic flaccid paralysis
    3. Diagnosis within the last 10 days

Prior Guillain-Barré Cohort Inclusion Criteria:

  1. Confirmed Guillain-Barré

    1. Acute onset of weakness or paralysis (from baseline to full weakness in 7 days)
    2. Weakness is symmetrical
    3. Areflexic (reflexes are 0/4)
    4. Diagnosis since January 2014
  2. Suspected Guillain-Barré

    1. Acute onset of illness
    2. Areflexic flaccid paralysis
    3. Clinical diagnosis of Guillain-Barré
    4. Diagnosis since January 2014

Exclusion Criteria all cohorts:

  • Adult participants unable to consent for themselves.

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): NCT02831699


Contacts
Contact: Jessica Mascareñas (52) 55 5573- 0734 jessicamascarenas@redmexei.mx
Contact: María Lourdes Guerrero (52) 55 5487-0900 ext 2420 or 2421 mlga08@gmail.com

Locations
Mexico
Hospital General de Tapachula Recruiting
Tapachula, Chiapas, Mexico
Contact: Emilia Ruiz    +52 1 962 133 4928    dramilieruiz@gmail.com   
Contact: Benjamin Hidalgo    +52 1 962 187 0387    benjaminhidalgo@redmexei.org.mx   
Principal Investigator: Emilia Ruiz         
Sub-Investigator: Benjamin Hidalgo         
Sub-Investigator: Arturo Tirado         
Hospital Regional de Alta Especialidad Ciudad Salud Recruiting
Chiapas, Mexico
Contact: José Gabriel Nájera Cancino    (52) 962 111 8986    gabnajera78@hotmail.com   
Principal Investigator: José Gabriel Nájera Cancino         
Principal Investigator: Paul Rodriguez de La Rosa         
Sub-Investigator: Karina del Carmen Trujillo Murillo         
Sub-Investigator: Luis Miguel Canseco Ávila         
Sub-Investigator: Sergio Domínguez Arrevillaga         
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE) Clínica Hospital Dr. Roberto Nettel Flores Recruiting
Chiapas, Mexico
Contact: Sandra Caballero Sosa    (52) 962 170 4122    sandyluzcs@hotmail.com   
Principal Investigator: Sandra Caballero Sosa         
Instituto Mexicano del Seguro Social (IMSS) Delegación Estatal / Hospital General de Zona con Medicina Familiar No. 1 Recruiting
Chiapas, Mexico
Contact: Héctor Armando Rincón León    (52) 962 6424829    hector.rinconl@imss.gob.mx   
Principal Investigator: Aldo César De la Torre Gómez         
Principal Investigator: Héctor Armando Rincón León         
Instituto Mexicano del Seguro Social (IMSS) Delegación Estatal / Unidad de Medicina Familiar No. 11 Recruiting
Chiapas, Mexico
Contact: Héctor Armando Rincón León    (52) 1 962 6424829    hector.rinconl@imss.gob.mx   
Principal Investigator: Karla Reyna Navarro Fuentes         
Principal Investigator: Héctor Armando Rincón León         
Sub-Investigator: Yadira Pérez Andrade         
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Ciudad de México, Mexico
Contact: Pablo Francisco Belaunzarán Zamudio    (52155) 2072 0907    p.belaunz@infecto.mx   
Principal Investigator: Pablo Francisco Belaunzarán Zamudio         
Sponsors and Collaborators
Mexican Emerging Infectious Diseases Clinical Research Network
Secretaria de Salud, Mexico
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: John Beigel Leidos Biomedical, Inc. Support to 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

Responsible Party: Mexican Emerging Infectious Diseases Clinical Research Network
ClinicalTrials.gov Identifier: NCT02831699     History of Changes
Other Study ID Numbers: Zik01
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mexican Emerging Infectious Diseases Clinical Research Network:
Zika
Guillain Barré

Additional relevant MeSH terms:
Dengue
Virus Diseases
Chikungunya Fever
Zika Virus Infection
Disease
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Alphavirus Infections
Togaviridae Infections
Pathologic Processes