ExanthemaCRIUSNCT07112846
Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections
An observational study of Exanthema and Dengue Fever, run by Hospital Israelita Albert Einstein.
Trial summary
Exanthematous fevers are a global public health problem. The spread of arboviruses due to various factors, including climate change, has resulted in major epidemics such as the one that occurred in Brazil in 2024, representing an extremely concerning scenario from both epidemiological and healthcare perspectives. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Exanthema, Dengue Fever, Chikungunya
- How many people
- 830 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants without symptoms suspicious for the diseases presented. Individuals with confirmed cases of the aforementioned infections prior to recruitment. Individuals who, even presenting the symptoms described in the inclusion criteria, did not have samples collected for viral panel testing.
Who may be able to join
- Individuals from newborns (zero years old) to 18 years of age, of both sexes.
- Suspected individuals with the following criteria:
- Measles: Presenting fever and rash associated with cough and/or runny nose and/or conjunctivitis, regardless of age or vaccination status;
- Rubella: Presenting fever, rash, and lymphadenopathy, regardless of age or vaccination status;
- Dengue and Chikungunya: Presenting myalgia, arthralgia, headache, retro-orbital pain, nausea, vomiting, rash, petechiae, positive tourniquet test, or leukopenia and/or lymph node enlargement;
- Individuals who, meeting the above criteria, underwent sample collection for viral panel testing for the differential diagnosis of exanthematous diseases."
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Exanthematous fevers are a global public health problem. The spread of arboviruses due to various factors, including climate change, has resulted in major epidemics such as the one that occurred in Brazil in 2024, representing an extremely concerning scenario from both epidemiological and healthcare perspectives. In addition to this, the reemergence of childhood exanthematous diseases in several countries, including Brazil, is alarming and occurs due to declining vaccination coverage and increased migratory movements. These diseases present overlapping clinical symptoms, and their differential diagnosis is often challenging, which, in a context of dengue and Chikungunya epidemics like the current one, may lead to underreporting of diseases such as measles and rubella. This project aims to build a prospective registry of the occurrence of dengue, Chikungunya, measles, and rubella in various healthcare centers in Brazil, in order to better understand the epidemiological scenario, identify clinical variables associated with different diagnoses, and describe healthcare bottlenecks that may hinder proper reporting and identification of these diseases.
- Conditions
- Exanthema, Dengue Fever, Chikungunya, Measles, Rubella
- Keywords
- exanthema, dengue fever, Chikungunya, measles, rubella, epidemiology
- Medical subject headings
- Exanthema, Dengue, Chikungunya Fever, Measles, Rubella
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of positive infections for one or more infectious diseases (rubella, measles, dengue, and Chikungunya)
Prevalence of positive infections for one or more infectious diseases (rubella, measles, dengue, and Chikungunya)
Measured: From enrollment to the end of follow-up (30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExanthemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112846
- Sponsor's protocol ID
- CRIUS study
- Acronym
- CRIUS
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections
- ClinicalTrials.gov ID
- NCT07112846
- Acronym / sponsor ID
- CRIUS / CRIUS study
- Conditions
- Exanthema, Dengue Fever, Chikungunya, Measles, Rubella
- Keywords
- exanthema, dengue fever, Chikungunya, measles, rubella, epidemiology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 830 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exanthematous fevers are a global public health problem. The spread of arboviruses due to various factors, including climate change, has resulted in major epidemics such as the one that occurred in Brazil in 2024, representing an extremely concerning scenario from both epidemiological and healthcare perspectives. In addition to this, the reemergence of childhood exanthematous diseases in several countries, including Brazil, is alarming and occurs due to declining vaccination coverage and increased migratory movements. These diseases present overlapping clinical symptoms, and their differential diagnosis is often challenging, which, in a context of dengue and Chikungunya epidemics like the current one, may lead to underreporting of diseases such as measles and rubella. This project aims to build a prospective registry of the occurrence of dengue, Chikungunya, measles, and rubella in various healthcare centers in Brazil, in order to better understand the epidemiological scenario, identify clinical variables associated with different diagnoses, and describe healthcare bottlenecks that may hinder proper reporting and identification of these diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants without symptoms suspicious for the diseases presented. Individuals with confirmed cases of the aforementioned infections prior to recruitment. Individuals who, even presenting the symptoms described in the inclusion criteria, did not have samples collected for viral panel testing.
Key inclusion criteria (6 listed)
- Individuals from newborns (zero years old) to 18 years of age, of both sexes.
- Measles: Presenting fever and rash associated with cough and/or runny nose and/or conjunctivitis, regardless of age or vaccination status;
- Rubella: Presenting fever, rash, and lymphadenopathy, regardless of age or vaccination status;
- Dengue and Chikungunya: Presenting myalgia, arthralgia, headache, retro-orbital pain, nausea, vomiting, rash, petechiae, positive tourniquet test, or leukopenia and/or lymph node enlargement;
- Individuals who, meeting the above criteria, underwent sample collection for viral panel testing for the differential diagnosis of exanthematous diseases."
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of positive infections for one or more infectious diseases (rubella, measles, dengue, and Chikungunya)
Time frame: From enrollment to the end of follow-up (30 days).
Prevalence of positive infections for one or more infectious diseases (rubella, measles, dengue, and Chikungunya)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Exanthema and Dengue Fever, run by Hospital Israelita Albert Einstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrique R A da Fonseca, PhD (+551121511233, henrique.fonseca@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of positive infections for one or more infectious diseases (rubella, measles, dengue, and Chikungunya) (time frame: From enrollment to the end of follow-up (30 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2025.