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)
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 t...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-07-01
|
| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-023-08292-y |
| _version_ | 1797769652248510464 |
|---|---|
| author | Giselle da Silva Duarte Alexandra D. Jones Luciano Pamplona de Goes Cavalcanti Moacyr Jesus Barreto de Melo Rêgo Guilherme S. Ribeiro Rosemary J. Boyton Dhelio Batista Pereira Julio Henrique Rosa Croda Fabio Trindade Maranhão Costa Angela Pinto Duarte Marcia Edilaine Lopes Consolaro Rodrigo Guerino Stabeli Fábio Juliano Negrão Jose Luiz Proenca-Modena Juan Miguel Villalobos-Salcedo Geraldo da Rocha Castelar Pinheiro Amanda Pinheiro de Barros Albuquerque Francisca Kalline de Almeida Barreto Jose Moreira Idalina Cristina Ferrari Patricia Martinez Évora Vânia Ramos Sela da Silva Marcus Vinicius Guimarães Lacerda Daniel M. Altmann REPLICK network André M. Siqueira |
| author_facet | Giselle da Silva Duarte Alexandra D. Jones Luciano Pamplona de Goes Cavalcanti Moacyr Jesus Barreto de Melo Rêgo Guilherme S. Ribeiro Rosemary J. Boyton Dhelio Batista Pereira Julio Henrique Rosa Croda Fabio Trindade Maranhão Costa Angela Pinto Duarte Marcia Edilaine Lopes Consolaro Rodrigo Guerino Stabeli Fábio Juliano Negrão Jose Luiz Proenca-Modena Juan Miguel Villalobos-Salcedo Geraldo da Rocha Castelar Pinheiro Amanda Pinheiro de Barros Albuquerque Francisca Kalline de Almeida Barreto Jose Moreira Idalina Cristina Ferrari Patricia Martinez Évora Vânia Ramos Sela da Silva Marcus Vinicius Guimarães Lacerda Daniel M. Altmann REPLICK network André M. Siqueira |
| author_sort | Giselle da Silva Duarte |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T21:12:08Z |
| format | Article |
| id | doaj.art-971e70649fb24de9818278544cb93d16 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-03-12T21:12:08Z |
| publishDate | 2023-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-971e70649fb24de9818278544cb93d162023-07-30T11:08:50ZengBMCBMC Infectious Diseases1471-23342023-07-0123111210.1186/s12879-023-08292-yMulticenter 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)Giselle da Silva Duarte0Alexandra D. Jones1Luciano Pamplona de Goes Cavalcanti2Moacyr Jesus Barreto de Melo Rêgo3Guilherme S. Ribeiro4Rosemary J. Boyton5Dhelio Batista Pereira6Julio Henrique Rosa Croda7Fabio Trindade Maranhão Costa8Angela Pinto Duarte9Marcia Edilaine Lopes Consolaro10Rodrigo Guerino Stabeli11Fábio Juliano Negrão12Jose Luiz Proenca-Modena13Juan Miguel Villalobos-Salcedo14Geraldo da Rocha Castelar Pinheiro15Amanda Pinheiro de Barros Albuquerque16Francisca Kalline de Almeida Barreto17Jose Moreira18Idalina Cristina Ferrari19Patricia Martinez Évora20Vânia Ramos Sela da Silva21Marcus Vinicius Guimarães Lacerda22Daniel M. Altmann23REPLICK networkAndré M. Siqueira24Laboratório de Pesquisa Clínica Em Doenças Febris Agudas, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo CruzUniversity of CaliforniaUniversidade Federal Do CearáDepartamento de Bioquímica, Universidade Federal de PernambucoInstituto Gonçalo Moniz, Fundação Oswaldo CruzImperial College of LondonCentro de Pesquisa Em Medicina Tropical de RondôniaFundação Oswaldo Cruz, Mato Grosso Do SulUniversidade Estadual de CampinasHospital das Clínicas, Universidade Federal de PernambucoDepartamento de Análises Clínicas E Biomedicina, Universidade Estadual de MaringáPlataforma de Medicina Translacional, Fundação Oswaldo CruzUniversidade Federal da Grande DouradosUniversidade Estadual de CampinasFundação Oswaldo CruzUniversidade Estadual Do Rio de JaneiroDepartamento de Bioquímica, Universidade Federal de PernambucoUniversidade Federal Do CearáLaboratório de Pesquisa Clínica Em Doenças Febris Agudas, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo CruzUniversidade Federal da Grande DouradosPlataforma de Medicina Translacional, Fundação Oswaldo CruzDepartamento de Análises Clínicas E Biomedicina, Universidade Estadual de MaringáFundação de Medicina Tropical Dr Heitor Vieira DouradoImperial College of LondonLaboratório de Pesquisa Clínica Em Doenças Febris Agudas, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo CruzAbstract 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.https://doi.org/10.1186/s12879-023-08292-yChikungunyaCohortBrazilRheumatic manifestations |
| spellingShingle | Giselle da Silva Duarte Alexandra D. Jones Luciano Pamplona de Goes Cavalcanti Moacyr Jesus Barreto de Melo Rêgo Guilherme S. Ribeiro Rosemary J. Boyton Dhelio Batista Pereira Julio Henrique Rosa Croda Fabio Trindade Maranhão Costa Angela Pinto Duarte Marcia Edilaine Lopes Consolaro Rodrigo Guerino Stabeli Fábio Juliano Negrão Jose Luiz Proenca-Modena Juan Miguel Villalobos-Salcedo Geraldo da Rocha Castelar Pinheiro Amanda Pinheiro de Barros Albuquerque Francisca Kalline de Almeida Barreto Jose Moreira Idalina Cristina Ferrari Patricia Martinez Évora Vânia Ramos Sela da Silva Marcus Vinicius Guimarães Lacerda Daniel M. Altmann REPLICK network André M. Siqueira 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) BMC Infectious Diseases Chikungunya Cohort Brazil Rheumatic manifestations |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Chikungunya Cohort Brazil Rheumatic manifestations |
| url | https://doi.org/10.1186/s12879-023-08292-y |
| work_keys_str_mv | AT giselledasilvaduarte multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT alexandradjones multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT lucianopamplonadegoescavalcanti multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT moacyrjesusbarretodemelorego multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT guilhermesribeiro multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT rosemaryjboyton multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT dheliobatistapereira multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT juliohenriquerosacroda multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT fabiotrindademaranhaocosta multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT angelapintoduarte multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT marciaedilainelopesconsolaro multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT rodrigoguerinostabeli multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT fabiojulianonegrao multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT joseluizproencamodena multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT juanmiguelvillalobossalcedo multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT geraldodarochacastelarpinheiro multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT amandapinheirodebarrosalbuquerque multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT franciscakallinedealmeidabarreto multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT josemoreira multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT idalinacristinaferrari multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT patriciamartinezevora multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT vaniaramosseladasilva multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT marcusviniciusguimaraeslacerda multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT danielmaltmann multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT replicknetwork multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork AT andremsiqueira multicenterstudyofthenaturalhistoryandtherapeuticresponsesofpatientswithchikungunyafocusingonacuteandchronicmusculoskeletalmanifestationsastudyprotocolfromtheclinicalandappliedresearchinchikungunyareplicknetwork |