학술논문
Multicenter study of the natural history and therapeutic responses of patients with chikungunya, focusing on acute and chronic musculoskeletal manifestations - a study protocol from the clinical and applied research in Chikungunya (REPLICK network).
Document Type
Academic Journal
Author
da Silva Duarte G; Laboratório de Pesquisa Clínica Em Doenças Febris Agudas, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.; Jones AD; University of California, Berkeley, USA.; de Goes Cavalcanti LP; Universidade Federal Do Ceará, Fortaleza, Brazil.; de Melo Rêgo MJB; Departamento de Bioquímica, Universidade Federal de Pernambuco, Recife, Brazil.; Ribeiro GS; Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil.; Boyton RJ; Imperial College of London, London, UK.; Pereira DB; Centro de Pesquisa Em Medicina Tropical de Rondônia, Porto Velho, Brazil.; Croda JHR; Fundação Oswaldo Cruz, Mato Grosso Do Sul, Campo Grande, Brazil.; Costa FTM; Universidade Estadual de Campinas, Campinas, Brazil.; Duarte AP; Hospital das Clínicas, Universidade Federal de Pernambuco, Recife, Brazil.; Consolaro MEL; Departamento de Análises Clínicas E Biomedicina, Universidade Estadual de Maringá, Maringá, Brazil.; Stabeli RG; Plataforma de Medicina Translacional, Fundação Oswaldo Cruz, São Paulo, Brazil.; Negrão FJ; Universidade Federal da Grande Dourados, Dourados, Brazil.; Proenca-Modena JL; Universidade Estadual de Campinas, Campinas, Brazil.; Villalobos-Salcedo JM; Fundação Oswaldo Cruz, São Paulo, Brazil.; da Rocha Castelar Pinheiro G; Universidade Estadual Do Rio de Janeiro, Rio de Janeiro, Brazil.; de Barros Albuquerque AP; Departamento de Bioquímica, Universidade Federal de Pernambuco, Recife, Brazil.; de Almeida Barreto FK; Universidade Federal Do Ceará, Fortaleza, Brazil.; Moreira J; Laboratório de Pesquisa Clínica Em Doenças Febris Agudas, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.; Ferrari IC; Universidade Federal da Grande Dourados, Dourados, Brazil.; Évora PM; Plataforma de Medicina Translacional, Fundação Oswaldo Cruz, São Paulo, Brazil.; da Silva VRS; Departamento de Análises Clínicas E Biomedicina, Universidade Estadual de Maringá, Maringá, Brazil.; Lacerda MVG; Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.; Altmann DM; Imperial College of London, London, UK.; Siqueira AM; Laboratório de Pesquisa Clínica Em Doenças Febris Agudas, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil. andre.siqueira@ini.fiocruz.br.
Source
Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2334 (Electronic) Linking ISSN: 14712334 NLM ISO Abbreviation: BMC Infect Dis Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Chikungunya is associated with high morbidity and the natural history of symptomatic infection has been divided into three phases (acute, post-acute, and chronic) according to the duration of musculoskeletal symptoms. Although this classification has been designed to help guide therapeutic decisions, it does not encompass the complexity of the clinical expression of the disease and does not assist in the evaluation of the prognosis of severity nor chronic disease. Thus, the current challenge is to identify and diagnose musculoskeletal disorders and to provide the optimal treatment in order to prevent perpetuation or progression to a potentially destructive disease course.
Methods: The study is the first product of the Clinical and Applied Research Network in Chikungunya (REPLICK). This is a prospective, outpatient department-based, multicenter cohort study in Brazil. Four work packages were defined: i. Clinical research; ii) Translational Science - comprising immunology and virology streams; iii) Epidemiology and Economics; iv) Therapeutic Response and clinical trials design. Scheduled appointments on days 21 (D21) ± 7 after enrollment, D90 ± 15, D120 ± 30, D180 ± 30; D360 ± 30; D720 ± 60, and D1080 ± 60 days. On these visits a panel of blood tests are collected in addition to the clinical report forms to obtain data on socio-demographic, medical history, physical examination and questionnaires devoted to the evaluation of musculoskeletal manifestations and overall health are performed. Participants are asked to consent for their specimens to be maintained in a biobank. Aliquots of blood, serum, saliva, PAXgene, and when clinically indicated to be examined, synovial fluid, are stored at -80° C. The study protocol was submitted and approved to the National IRB and local IRB at each study site.
Discussion: Standardized and harmonized patient cohorts are needed to provide better estimates of chronic arthralgia development, the clinical spectra of acute and chronic disease and investigation of associated risk factors. This study is the largest evaluation of the long-term sequelae of individuals infected with CHIKV in the Brazilian population focusing on musculoskeletal manifestations, mental health, quality of life, and chronic pain. This information will both define disease burden and costs associated with CHIKV infection, and better inform therapeutic guidelines.
(© 2023. The Author(s).)
Methods: The study is the first product of the Clinical and Applied Research Network in Chikungunya (REPLICK). This is a prospective, outpatient department-based, multicenter cohort study in Brazil. Four work packages were defined: i. Clinical research; ii) Translational Science - comprising immunology and virology streams; iii) Epidemiology and Economics; iv) Therapeutic Response and clinical trials design. Scheduled appointments on days 21 (D21) ± 7 after enrollment, D90 ± 15, D120 ± 30, D180 ± 30; D360 ± 30; D720 ± 60, and D1080 ± 60 days. On these visits a panel of blood tests are collected in addition to the clinical report forms to obtain data on socio-demographic, medical history, physical examination and questionnaires devoted to the evaluation of musculoskeletal manifestations and overall health are performed. Participants are asked to consent for their specimens to be maintained in a biobank. Aliquots of blood, serum, saliva, PAXgene, and when clinically indicated to be examined, synovial fluid, are stored at -80° C. The study protocol was submitted and approved to the National IRB and local IRB at each study site.
Discussion: Standardized and harmonized patient cohorts are needed to provide better estimates of chronic arthralgia development, the clinical spectra of acute and chronic disease and investigation of associated risk factors. This study is the largest evaluation of the long-term sequelae of individuals infected with CHIKV in the Brazilian population focusing on musculoskeletal manifestations, mental health, quality of life, and chronic pain. This information will both define disease burden and costs associated with CHIKV infection, and better inform therapeutic guidelines.
(© 2023. The Author(s).)