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Studying the consequences of Chikungunya and increasing the peoples’ quality of life

Multicenter study of the natural history and therapeutic responses of patients with Chikungunya, focusing on acute and chronic musculoskeletal manifestations

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-3qg2my
Enrollment
Unknown
Registered
2019-12-19
Start date
2019-09-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chikungunya Fever

Interventions

Design: a prospective cohort Follow-up period: 3 years Research Procedures and Conduct Patients arriving at recruiting centers with suspected cases of Dengue (DENV), Zika (ZIKV) or Chikungunya (CHIK
D90
D120
D180
D360
D720
D1080 days. On these visits, the same instruments will be applied and biological samples collected. Unscheduled visits for the purpose of the study will be made under the following conditions: a) wors
b) management any adverse event
c) decompensation of an underlying disease
d) at the discretion of the study team (eg reevaluation). On these unscheduled visits, in addition to the instruments defined for the scheduled visits, a questionnaire will be applied which contemplat
Other
H01.770.644.145.360

Sponsors

Instituto Nacional de Infectologia Evandro Chagas/Fundacao Oswaldo Cruz (INI/Fiocruz)
Lead Sponsor
Departamento de Ciência e Tecnologia do Ministério da Saúde
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age equals or more than 18 years; patients with recent fever, less than 10 days, with suspected CHIKV, ZIKV or DENV; patients with arthralgia after having a fever, more than 10 days, with suspected CHIKV, ZIKV or DENV

Exclusion criteria

Exclusion criteria: Patients unavailable to attend follow-up at the centers; presence of overt fever from a supposed non-viral origin (eg, cellulitis and abscess); patients with severe mental disorders or from whom the collection of information is not possible due to communication disorders or lack of fluency in Portuguese or another language understood by the attending physician; pregnant or lactating patients

Design outcomes

Primary

MeasureTime frame
We expect to evaluate the natural history and therapeutic response of musculoskeletal manifestations of patients affected by CHIKV in the Brazilian territory

Secondary

MeasureTime frame
We expect to evaluate the clinical manifestations of CHIKV infection and its evolution in patients in different states of the Brazilian territory;We expect to investigate the risk and prognostic factors associated with the severity and persistence of clinical manifestations, focusing on musculoskeletal changes and chronicity rates;We expect to estimate the socioeconomic, labor, and psychosocial impact of CHIK infection;We expect to perform differential diagnosis between CHIKV, ZIKV, and DENV by real-time multiplex polymerase chain reaction in acute cases;We expect to evaluate the positivity rates for CHIKV by RT-PCR in whole blood, plasma and serum at different stages of infection to establish protocols based on the best positivity rates;We expect to establish the prevalence, viral load and duration of CHIKV infection in different body fluids at different stages of infection, contributing to the elucidation of viral kinetics (pathophysiology or natural history) in different body fluids;We expect to evaluate possible windows for diagnostic possibilities and follow-up of infection in different biological fluids;We expect to establish possible cell lines in which CHIKV may present cell tropism, based on saliva and urine analyses;We expect to correlate the immunological and virological aspects with the clinical manifestations of CHIK patients;We expect to constitute a biorepository of clinically well-characterized samples that can be shared for the evaluation of diagnostic tests and biomarkers that advance the understanding and better clinical and therapeutic management of patients with CHIKV

Countries

Brazil

Contacts

Public ContactJosé Moreira

Instituto Nacional de Infectologia Evandro Chagas/Fundacao Oswaldo Cruz (INI/Fiocruz)

josemoreyyra@gmail.com+55(21)970358843

Outcome results

None listed

Source: REBEC (via WHO ICTRP)