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)
ARTIGO
Inglês
Agradecimentos: For the investigators of the REPLICK Network: Thyago Henrique Pereira dos Santos, Fernanda Montenegro de Carvalho Araujo; Luis Arthur Brazil Gadelha Farias, Lara Moreira Teles de Vasconcelos; Brena Ferreira dos Santos; Shamyr Sulyvan de Castro; Marina Carvalho Arruda Barreto; Ileana...
Agradecimentos: For the investigators of the REPLICK Network: Thyago Henrique Pereira dos Santos, Fernanda Montenegro de Carvalho Araujo; Luis Arthur Brazil Gadelha Farias, Lara Moreira Teles de Vasconcelos; Brena Ferreira dos Santos; Shamyr Sulyvan de Castro; Marina Carvalho Arruda Barreto; Ileana Pitombeira Gomes; Jobson Lopes de Oliveira; Thayanne Vitoria Nunes Pinheiro; Samara Bezerra Guedes das Neves; Carla Cristiana Judice; Gabriela Fabiano de Souza; Matheus Cavalheiro Martini; Deusilene Souza Vieira Dall’Acqua; Marcela Macedo de Oliveira; Eduardo Garbin; Alexia Martines; Maira Galdino da Rocha Pitta; Luiz Demarchi; Caroline Santos Soares. REPLICK Network Members Giselle da Silva Duarte1, Luciano Pamplona de Goes Cavalcanti3, Moacyr Jesus Barreto de Melo Rêgo4, Guilherme S. Ribeiro5, Dhelio Batista Pereira7, Julio Henrique Rosa Croda8, Fabio Trindade Maranhão Costa9, Angela Pinto Duarte10, Marcia Edilaine Lopes Consolaro11, Rodrigo Guerino Stabeli12, Fábio Juliano Negrão13, Jose Luiz Proenca-Modena9, Geraldo da Rocha Castelar Pinheiro15, Amanda Pinheiro de Barros Albuquerque4, Francisca Kalline de Almeida Barreto3, Idalina Cristina Ferrari13, Vânia Ramos Sela da Silva11, Marcus Vinicius Guimarães Lacerda16, André M. Siqueira1 Thyago Henrique Pereira dos Santos3, Fernanda Montenegro de Carvalho Araujo3, Luis Arthur Brazil Gadelha Farias3, Lara Moreira Teles de Vasconcelos3, Brena Ferreira dos Santos3, Shamyr Sulyvan de Castro3, Marina Carvalho Arruda Barreto3, Ileana Pitombeira Gomes3, Jobson Lopes de Oliveira3, Thayanne Vitoria Nunes Pinheiro3, Samara Bezerra Guedes das Neves3, Carla Cristiana Judice9, Gabriela Fabiano de Souza33, Matheus Cavalheiro Martini9, Deusilene Souza Vieira Dall’Acqua14, Marcela Macedo de Oliveira7, Eduardo Garbin7, Alexia Martines; Maira Galdino da Rocha Pitta4, Luiz Demarchi3, Caroline Santos Soares1, Patricia Brasil1, Karen Trinta17, Claudia Pereira18. 17Biomanguinhos, Fiocruz, Rio de Janeiro, Brazil 18Escola Nacional de Saude Publica - ENSP - Fiocruz, Rio de Janeiro, Brazil This project is funded by the Science and Technology Department from the Brazilian Ministry of Health (Grant id: Thematic FAPESP protocol number 2018/14372–0). Fundação Cearense de Apoio ao Desenvolvimento Científico e Tecnológico (FUNCAP 01/2017-SUS/PPSUS-CE FUNCAP SESA Decit/SCTIE)
Abstract: 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...
Abstract: 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. 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. 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
FUNDAÇÃO DE AMPARO À PESQUISA DO ESTADO DE SÃO PAULO - FAPESP
2018/14372–0
FUNDAÇÃO CEARENSE DE APOIO AO DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO - FUNCAP
01/2017
Aberto
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)
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)
Fontes
BMC infectious diseases v. 23, n. art. 499, July 2023 |