Use este identificador para citar ou linkar para este item: https://www.arca.fiocruz.br/handle/icict/65922

Tipo de documento
Artigo
Direito Autoral
Acesso aberto
Objetivos de Desenvolvimento Sustentável
05 Igualdade de gênero
Coleções
Compartilhar

Estatísticas
Metadata
Mostrar registro completo

STUDY PROTOCOL FOR THE MULTICENTRE COHORTS OF ZIKA VIRUS INFECTION IN PREGNANT WOMEN, INFANTS, AND ACUTE CLINICAL CASES IN LATIN AMERICA AND THE CARIBBEAN: THE ZIKALLIANCE CONSORTIUM
Avelino-Silva, Vivian I. et al. | Data do documento: 2019
Autor(es)
Avelino-Silva, Vivian I.
Mayaud, Philippe
Tami, Adriana
Miranda, Maria C.
Rosenberger, Kerstin D.
Alexander, Neal
Nacul, Luis
Segurado, Aluisio
Pohl, Moritz
Bethencourt, Sarah
Villar, Luis A.
Viana, Isabelle F. T.
Rabello, Renata
Soria, Carmen
Salgado, Silvia P.
Gotuzzo, Eduardo
Guzmán, María G.
Martínez, Pedro A.
López-Gatell, Hugo
Hegewisch-Taylor, Jennifer
Borja-Aburto, Victor H.
Gonzalez, Cesar
Netto, Eduardo M.
Villarroel, Paola M. Saba
Hoen, Bruno
Brasil, Patrícia
Marques, Ernesto T. A.
Rockx, Barry
Koopmans, Marion
Lamballerie, Xavier de
Jaenisch, Thomas
Afiliação
Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. Departamento de Doenças Infecciosas e Parasitárias. São Paulo, SP, Brasil / Hospital Sírio-Libanês. São Paulo, SP, Brasil.
London School of Hygiene and Tropical Medicine. London, UK.
University Medical Center Groningen. University of Groningen. Department of Medical Microbiology. Groningen, The Netherlands / Universidad de Carabobo. Facultad de Ciencias de la Salud. Valencia, Venezuela.
Universidad Industrial de Santander. Bucaramanga, Colombia.
Heidelberg University Hospital. Section Clinical Tropical Medicine. Department of Infectious Diseases. Heidelberg, Germany / German Centre for Infection Research. Heidelberg Site. Cologne, Germany.
London School of Hygiene and Tropical Medicine. London, UK.
London School of Hygiene and Tropical Medicine. London, UK.
Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. Departamento de Doenças Infecciosas e Parasitárias. São Paulo, SP, Brasil.
Heidelberg University Hospital. Institute of Medical Biometry and Informatic. Heidelberg, Germany.
Universidad de Carabobo. Facultad de Ciencias de la Salud. Valencia, Venezuela.
Universidad Industrial de Santander. Bucaramanga, Colombia.
Oswaldo Cruz Foundation. Aggeu Magalhães Institute. Recife, PE, Brazil.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases Rio de Janeiro, RJ, Brazil.
Universidad Católica Santiago de Guayaquil. Guayaquil, Ecuador / SOSECALI C. Ltda. Guayaquil, Ecuador.
Instituto Nacional de Investigación en Salud Pública “Dr. Leopoldo Izquieta Pérez”. Guayaquil, Ecuador.
Universidad Peruana Cayetano Heredia. Instituto de Medicina Tropical Alexander von Humboldt. Lima, Peru.
Pedro Kouri Tropical Medicine Institute. Havana, Cuba.
Pedro Kouri Tropical Medicine Institute. Havana, Cuba.
Instituto Nacional de Salud Pública. Centro de Investigación sobre Enfermedades Infecciosas. Cuernavaca, Mexico.
Instituto Nacional de Salud Pública. Centro de Investigación sobre Enfermedades Infecciosas. Cuernavaca, Mexico.
Mexican Institute of Social Security. Mexico City, Mexico.
Mexican Institute of Social Security. Mexico City, Mexico.
Federal University of Bahia. Salvador, BA, Brazil.
Centro Nacional de Enfermedades Tropicales. Santa Cruz, de la Sierra, Bolivia.
INSERM Centre d’Investigation Clinique. Centre Hospitalier Universitaire de Pointe-à-Pitre. Pointe-à-Pitre, France / Service de Maladies Infectieuses et Tropicales, Dermatologie, Médecine Interne. Centre Hospitalier Universitaire de Pointe-à-Pitre. Pointe-à-Pitre, France / Université des Antilles et de la Guyane. Faculté de Médecine Hyacinthe Bastaraud. Pointe-à-Pitre, France.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Rio de Janeiro, RJ, Brazil.
University of Pittsburgh. Center for Vaccine Research. Pittsburgh, PA, USA.
Department of Viroscience. WHO CC Arbovirus and hemorrhagic fever viruses reference and research. Erasmus MC. Rotterdam, The Netherlands.
Department of Viroscience. WHO CC Arbovirus and hemorrhagic fever viruses reference and research. Erasmus MC. Rotterdam, The Netherlands.
Aix-Marseille University, Marseille, France.
Heidelberg University Hospital. Section Clinical Tropical Medicine. Department of Infectious Diseases. Heidelberg, Germany / German Centre for Infection Research. Heidelberg Site. Cologne, Germany.
Resumo em Inglês
Background: The European Commission (EC) Horizon 2020 (H2020)-funded ZIKAlliance Consortium designed a multicentre study including pregnant women (PW), children (CH) and natural history (NH) cohorts. Clinical sites were selected over a wide geographic range within Latin America and the Caribbean, taking into account the dynamic course of the ZIKV epidemic. Methods: Recruitment to the PW cohort will take place in antenatal care clinics. PW will be enrolled regardless of symptoms and followed over the course of pregnancy, approximately every 4 weeks. PW will be revisited at delivery (or after miscarriage/abortion) to assess birth outcomes, including microcephaly and other congenital abnormalities according to the evolving definition of congenital Zika syndrome (CZS). After birth, children will be followed for 2 years in the CH cohort. Follow-up visits are scheduled at ages 1–3, 4–6, 12, and 24 months to assess neurocognitive and developmental milestones. In addition, a NH cohort for the characterization of symptomatic rash/fever illness was designed, including follow-up to capture persisting health problems. Blood, urine, and other biological materials will be collected, and tested for ZIKV and other relevant arboviral diseases (dengue, chikungunya, yellow fever) using RT-PCR or serological methods. A virtual, decentralized biobank will be created. Reciprocal clinical monitoring has been established between partner sites. Substudies of ZIKV seroprevalence, transmission clustering, disabilities and health economics, viral kinetics, the potential role of antibody enhancement, and co-infections will be linked to the cohort studies. Discussion: Results of these large cohort studies will provide better risk estimates for birth defects and other developmental abnormalities associated with ZIKV infection including possible co-factors for the variability of risk estimates between other countries and regions. Additional outcomes include incidence and transmission estimates of ZIKV during and after pregnancy, characterization of short and long-term clinical course following infection and viral kinetics of ZIKV. Study registrations: clinicaltrials.gov NCT03188731 (PW cohort), June 15, 2017; clinicaltrials.gov NCT03393286 (CH cohort), January 8, 2018; clinicaltrials.gov NCT03204409 (NH cohort), July 2, 2017.
Palavras-chave em inglês
Zika
Pregnant women
Children
Cohort
Latin America
Caribbean
Risk
Congenital abnormalities
Natural history
Arboviruses
Mosquito-borne viruses
Vector-borne viruses
 
Editor
BMC
Referência
Avelino-Silva, Vivian I. et al. Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium. BMC Infectious Diseases, v. 19, p. 1-14, Dec. 2019.
DOI
10.1186/s12879-019-4685-9
ISSN
1471-2334
Notas
The ZIKAlliance Clinical Study Group: Thomas Jaenisch, Kerstin Daniela Rosenberger, Ivonne Morales, Frank Tobian, Lorenz Uhlmann, Moritz Pohl, Julius Schretzmann, Annika Leege, Ernesto T. A. Marques, Isabelle F. T. Viana, Roberto D. Lins, Patrícia Brasil, Ana Maria Bispo de Filippis, Ana Claudia Machado Duarte, Otavio de Melo Espíndola, Myrna Bonaldo, Renata Rabello, Luana Damasceno, Vivian Avelino-Silva, Aluisio Segurado, Ester Sabino, Maria Cassia Mendes-Correa, Luis Nacul, Neal Alexander, Eduardo Martins Netto, Adriana Tami, Sarah Bethencourt, Cristel Falcon, Egri Rodríguez, Victmar Matos, Maria José Tinedo, Yenifer La Rosa, Marianela Murillo, Luis Angel Villar, Maria Consuelo Miranda, Anyela Lozano, Victor Mauricio Herrera, Adriana Gomez, Rosa Margarita Gelvez, Ricardo Ortiz, Carmen Soria, Lady Dimitrakis, Silvia Paola Salgado, Mary Regato Arrata, Eduardo Gotuzzo, Humberto Guerra Allison, Michael Talledo, Paola Mariela Saba Villarroel, Eric Martínez Torres, María G. Guzmán, Pedro A. Martínez Rodríguez, Mayling Alvarez Vera, Belkis Galindo Santana, Alicia Reyes, Silvia Serrano Álvarez, Diana Ferriol Dorticós, Jennifer Hegewisch-Taylor, Celia Alpuche-Aranda, Hugo López-Gatell, Esteban González-Diaz, Norma Pavía-Ruz, Victor Hugo Borja-Aburto, Cesar Gonzalez, Concepción Grajales, Teresita Rojas, Lumumba Arriaga, Alfonso Vallejos, Bruno Hoen, Dominique Tynevez, Xavier de Lamballerie, Laurence Thirion, Jan Felix Drexler, Barry Rockx, Eric van Gorp & Marion Koopmans.