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

被引:8
作者
Avelino-Silva, Vivian I. [4 ,31 ,32 ,33 ]
Mayaud, Philippe [5 ,34 ]
Tami, Adriana [7 ,9 ,10 ,35 ,36 ]
Miranda, Maria C. [37 ]
Rosenberger, Kerstin D. [38 ,39 ]
Alexander, Neal [5 ,34 ]
Nacul, Luis [5 ,34 ]
Segurado, Aluisio [4 ,31 ,32 ]
Pohl, Moritz [1 ,40 ]
Bethencourt, Sarah [8 ,36 ]
Villar, Luis A. [37 ]
Viana, Isabelle F. T. [3 ,41 ]
Rabello, Renata [3 ,42 ]
Soria, Carmen [16 ,43 ,44 ]
Salgado, Silvia P. [45 ]
Gotuzzo, Eduardo [6 ,18 ,46 ]
Guzman, Maria G. [20 ,47 ]
Martinez, Pedro A. [47 ]
Lopez-Gatell, Hugo [22 ,48 ]
Hegewisch-Taylor, Jennifer [22 ,48 ]
Borja-Aburto, Victor H. [49 ]
Gonzalez, Cesar [25 ,49 ]
Netto, Eduardo M. [50 ]
Villarroel, Paola M. Saba [51 ]
Hoen, Bruno [52 ,53 ,54 ]
Brasil, Patricia [42 ]
Marques, Ernesto T. A. [2 ,8 ,57 ]
Rockx, Barry [30 ,55 ]
Koopmans, Marion [30 ,55 ]
de Lamballerie, Xavier [26 ,56 ]
Jaenisch, Thomas [1 ,38 ,39 ]
Jaenisch, Thomas [1 ,38 ,39 ]
Rosenberger, Kerstin Daniela [1 ]
Morales, Ivonne [1 ]
Tobian, Frank [1 ]
Uhlmann, Lorenz [1 ]
Pohl, Moritz [1 ,40 ]
Schretzmann, Julius [1 ]
Leege, Annika [1 ]
Marques, Ernesto T. A. [2 ,8 ,57 ]
Marques, Ernesto T. A. [2 ,8 ,57 ]
Viana, Isabelle F. T. [3 ,41 ]
Lins, Roberto D. [3 ]
Bispo de Filippis, Ana Maria [3 ]
Machado Duarte, Ana Claudia [3 ]
Espindola, Otavio de Melo [3 ]
Bonaldo, Myrna [3 ]
Rabello, Renata [3 ,42 ]
Damasceno, Luana [3 ]
Mendes-Correa, Maria Cassia [4 ]
机构
[1] Univ Heidelberg Hosp, Heidelberg, Germany
[2] Univ Pittsburgh, Ctr Vaccine Res, Pittsburgh, PA USA
[3] Aggeu Magalhaes Inst, Oswaldo Cruz Fdn, Recife, PE, Brazil
[4] Univ Sao Paulo, Sao Paulo, Brazil
[5] LSHTM, London, England
[6] Fed Univ Bahia UFB, Salvador, BA, Brazil
[7] Univ Groningen, Univ Med Ctr Groningen, Dept Med Microbiol, Groningen, Netherlands
[8] Univ Carabobo, Fac Ciencias Salud, Valencia, Venezuela
[9] Univ Groningen, Univ Med Ctr Groningen, Dept Med Microbiol, Groningen, Netherlands
[10] Univ Carabobo, Fac Ciencias Salud, Valencia, Venezuela
[11] Ciudad Hosp Enrique Tejera, Valencia, Spain
[12] Ctr Policlin Valencia Vina, Lab Clin Vina, Valencia, Venezuela
[13] Inst Especialidades Quirurg Ios Mangos, Valencia, Venezuela
[14] Univ Ind Santander, Bucaramanga, Colombia
[15] Univ Autonoma Bucaramanga UNAB Hosp Local Norte I, Bucaramanga, Colombia
[16] Univ Catolica Santiago Guayaquil, SOSECALI C Ltda, Guayaquil, Ecuador
[17] Inst Nacl Invest Salud Publ Dr Leopoldo Izquieta, Guayaquil, Ecuador
[18] Univ Peruana Cayetano Heredia, Inst Med Trop Alexander Humboldt, Humboldt, Germany
[19] Ctr Nacl Enfermedades Trop CENETROP, Santa Cruz, CA, Bolivia
[20] Pedro Kouri Trop Med Inst IPK, Havana, Cuba
[21] MINSAP, Secc Materno Infantil, Cienfuegos, Cuba
[22] Inst Nacl Salud Publ, Ctr Invest Enfermedades Infecciosas Inst, Cuernavaca, Morelos, Mexico
[23] Hosp Civil Guadalajara, Unidad Vigilancia Epidemiol Hosp Med Prevent, Fray Antonio Alcalde O P, Mexico
[24] Univ Autonoma Yucatan, Ctr Invest Reg Dr Hideyo Noguchi, Mexico City, DF, Mexico
[25] INSERM, Concepcion, Chile
[26] AixMarseille Univ, Inserm 1207, INSERM Gouadelo, IRD 190,Unite Virus Emergents, Marseille, France
[27] Charite Univ Med Berlin, Berlin, Germany
[28] Free Univ Berlin, Berlin, Germany
[29] Berlin Inst Hlth, Inst Virol, Berlin, Germany
[30] Erasmus MC, Rotterdam, Netherlands
[31] Univ Sao Paulo, Fac Med, Dept Infect & Parasit Dis, Sao Paulo, Brazil
[32] Univ Sao Paulo, Fac Med, Inst Med Trop, Sao Paulo, Brazil
[33] Hosp Sirio Libanes, Sao Paulo, Brazil
[34] London Sch Hyg & Trop Med, London, England
[35] Univ Groningen, Univ Med Ctr Groningen, Dept Med Microbiol, Groningen, Netherlands
[36] Univ Carabobo, Fac Ciencias Salud, Valencia, Venezuela
[37] Univ Ind Santander, Bucaramanga, Colombia
[38] Heidelberg Univ Hosp, Sect Clin Trop Med, Dept Infect Dis, INF 324, D-69120 Heidelberg, Germany
[39] German Ctr Infect Res DZIF, Heidelberg Site, Cologne, Germany
[40] Heidelberg Univ Hosp, Inst Med Biometry & Informat, Heidelberg, Germany
[41] Fundacao Oswaldo Cruz, FIOCRUZ, Aggeu Magalhaes Inst, Recife, PE, Brazil
[42] Fundacao Oswaldo Cruz, FIOCRUZ, Evandro Chagas Natl Inst Infect Dis, Rio De Janeiro, Brazil
[43] Univ Catolic Santiago Guayaquil, Guayaquil, Ecuador
[44] SOSECALI C Ltda, Guayaquil, Ecuador
[45] Inst Nacl Invest Salud Publ Dr Leopold Izquieta P, Guayaquil, Ecuador
[46] Univ Peruana Cayetano Heredia, Inst Med Trop Alexander von Humboldt, Lima, Peru
[47] Pedro Kouri Trop Med Inst IPK, Havana, Cuba
[48] Inst Nacl Salud Publ, Ctr Invest Enfermedades Infecciosas, Cuernavaca, Morelos, Mexico
[49] Mexican Inst Social Secur, Mexico City, Mexico
[50] Univ Fed Bahia, Salvador, BA, Brazil
基金
欧盟地平线“2020”;
关键词
Zika; Pregnant women; Children; Cohort; Latin America; Caribbean; Risk; Congenital abnormalities; Natural history; Arboviruses; Mosquito-borne viruses; Vector-borne viruses; EXTERNAL QUALITY ASSESSMENT; GUILLAIN-BARRE-SYNDROME; BIRTH-DEFECTS; SEXUAL TRANSMISSION; MOLECULAR-DETECTION; BRAZIL; EPIDEMIC; LABORATORIES; TERRITORIES; OUTCOMES;
D O I
10.1186/s12879-019-4685-9
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
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.
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页数:14
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