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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)

2023; BioMed Central; Volume: 23; Issue: 1 Linguagem: Inglês

10.1186/s12879-023-08292-y

1471-2334

Giselle da Silva Duarte, Alexandra D. Jones, Luciano Pamplona de Góes Cavalcanti, Moacyr Jesus Barreto de Melo Rêgo, Guilherme S. Ribeiro, Rosemary J. Boyton, Dhélio B. Pereira, Júlio Croda, Fábio Trindade Maranhão Costa, Ângela Luzia Branco Pinto Duarte, Márcia Edilaine Lopes Consolaro, Rodrigo G. Stábeli, Fábio Juliano Negrão, José Luiz Proença‐Módena, Juan Miguel Villalobos-Salcedo, Geraldo da Rocha Castelar Pinheiro, Amanda Pinheiro de Barros Albuquerque, Francisca Kalline de Almeida Barreto, José Moreira, Idalina Cristina Ferrari, Patrícia Martinez Évora, Vânia Ramos Sela da Silva, Marcus Lacerda, Daniel M. Altmann, Thyago Henrique Pereira dos Santos, Fernanda Montenegro de Carvalho Araújo, 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, Maíra Galdino da Rocha Pitta, Luiz Henrique Ferraz Demarchi, Caroline Santos Soares, Patrícia Brasil, Karen Soares Trinta, Claudia Cristina de Aguiar Pereira, André M. Siqueira,

Parasites and Host Interactions

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.