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

December 16, 2020 updated by: Mexican Emerging Infectious Diseases Clinical Research Network

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • 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
      • Ciudad de México, Mexico
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    • Chiapas
      • Tapachula, Chiapas, Mexico
        • Hospital General de Tapachula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 20 days)
    2. Weakness is symmetrical
    3. Areflexic (reflexes are 0/4)

  2. Suspected Guillain-Barré

    1. Acute onset of illness
    2. Areflexic flaccid paralysis

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mexican Emerging Infectious Diseases Clinical Research Network

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Secretaria de Salud, Mexico

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 21, 2016

Primary Completion (ACTUAL)

January 25, 2019

Study Completion (ACTUAL)

January 25, 2019

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (ESTIMATE)

July 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zik01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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