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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02831699
Date of registration:	11/07/2016
Prospective Registration:	No
Primary sponsor:	Mexican Emerging Infectious Diseases Clinical Research Network
Public title:	The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico Zik01
Scientific title:	The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico (Zik01)
Date of first enrolment:	June 21, 2016
Target sample size:	600
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02831699
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Mexico

Contacts

Name:	Pablo Francisco Belaunzarán Zamudio
Address:
Telephone:
Email:
Affiliation:	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Name:	Guillermo Ruiz-Palacios
Address:
Telephone:
Email:
Affiliation:	Mexican Emerging Infectious Diseases Clinical Research Network

Name:	Sophia Siddiqui
Address:
Telephone:
Email:
Affiliation:	National Institute of Allergy and Infectious Diseases (NIAID)

Key inclusion & exclusion 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

Age minimum: 1 Year
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chikungunya

Zika Virus Disease (Disorder)

Dengue

Intervention(s)

Primary Outcome(s)

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]

Secondary Outcome(s)

Secondary ID(s)

Zik01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Secretaria de Salud, Mexico

National Institute of Allergy and Infectious Diseases (NIAID)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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