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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 : Completed
First Posted : July 13, 2016
Last Update Posted : December 17, 2020
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

Tracking Information
First Submitted Date July 11, 2016
First Posted Date July 13, 2016
Last Update Posted Date December 17, 2020
Actual Study Start Date June 21, 2016
Actual Primary Completion Date January 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2016)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico
Official Title The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico (Zik01)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine samples Blood samples
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.
Condition
  • Zika Virus Disease (Disorder)
  • Dengue
  • Chikungunya
Intervention Not Provided
Study Groups/Cohorts
  • Febrile Rash
  • Household
  • Guillain-Barré prospective
  • Prior Guillain-Barré
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 12, 2016)
600
Original Estimated Enrollment Same as current
Actual Study Completion Date January 25, 2019
Actual Primary Completion Date January 25, 2019   (Final data collection date for primary outcome measure)
Eligibility 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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT02831699
Other Study ID Numbers Zik01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mexican Emerging Infectious Diseases Clinical Research Network
Study Sponsor Mexican Emerging Infectious Diseases Clinical Research Network
Collaborators
  • Secretaria de Salud, Mexico
  • National Institute of Allergy and Infectious Diseases (NIAID)
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
PRS Account Mexican Emerging Infectious Diseases Clinical Research Network
Verification Date December 2020