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Zika Virus Disease (Disorder)Zik01NCT02831699

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

An observational study of Zika Virus Disease (Disorder) and Dengue, run by Mexican Emerging Infectious Diseases Clinical Research Network at 6 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Zika Virus Disease (Disorder), Dengue, Chikungunya
How many people
600 participants
Where
6 sitesMexico
Study dates
21 Jun 2016to 25 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

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):
  2. One or both of the following primary signs:
  • Rash
  • Elevated body temperature (> 37.2 °C) AND
  1. One or more of the following symptoms (not explained by other medical conditions):
  • Arthralgia
  • Myalgia
  • Non-purulent conjunctivitis or conjunctival hyperemia
  • Headache
  • Malaise AND
  1. Onset of illness in the last 7 days
  2. Modified case definition (a and b):
  3. Any two of the following:
  • Rash
  • Elevated body temperature (> 37.2 °C)
  • Arthralgia
  • Myalgia
  • Non-purulent conjunctivitis or conjunctival hyperemia
  • Headache
  • Malaise AND
  1. 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
  2. Acute onset of weakness or paralysis (from baseline to full weakness in 20 days)
  3. Weakness is symmetrical
  4. Areflexic (reflexes are 0/4)
  5. Suspected Guillain-Barré
  6. Acute onset of illness
  7. Areflexic flaccid paralysis

Prior Guillain-Barré Cohort Inclusion Criteria:

  1. Confirmed Guillain-Barré
  2. Acute onset of weakness or paralysis (from baseline to full weakness in 7 days)
  3. Weakness is symmetrical
  4. Areflexic (reflexes are 0/4)
  5. Diagnosis since January 2014
  6. Suspected Guillain-Barré
  7. Acute onset of illness
  8. Areflexic flaccid paralysis
  9. Clinical diagnosis of Guillain-Barré
  10. Diagnosis since January 2014

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Mexico6 sites

  • Hospital Regional de Alta Especialidad Ciudad Salud

    Chiapas

  • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE) Clínica Hospital Dr. Roberto Nettel Flores

    Chiapas

  • Instituto Mexicano del Seguro Social (IMSS) Delegación Estatal / Hospital General de Zona con Medicina Familiar No. 1

    Chiapas

  • Instituto Mexicano del Seguro Social (IMSS) Delegación Estatal / Unidad de Medicina Familiar No. 11

    Chiapas

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City

  • Hospital General de Tapachula

    Tapachula, Chiapas

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Keywords
Zika, Guillain Barré
Medical subject headings
Zika Virus Infection, Dengue, Chikungunya Fever, Guillain-Barre Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02831699
Study groupRoleWhat they receive
Febrile RashNot described
HouseholdNot described
Guillain-Barré prospectiveNot described
Prior Guillain-BarréNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study start21 Jun 2016
  3. Primary completion25 Jan 2019
  4. Study completion25 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831699
Sponsor's protocol ID
Zik01
Acronym
Zik01
Status last verified
Dec 2020
First submitted
11 Jul 2016
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34454432

  • Belaunzaran-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.

    PubMed 33828518

  • Gouel-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.

    PubMed 31672665

Questions about this trial

What is this clinical trial studying?

An observational study of Zika Virus Disease (Disorder) and Dengue, run by Mexican Emerging Infectious Diseases Clinical Research Network at 6 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02831699, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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