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dc.contributor.authorAndrade, Ana Lúcia Sampaio Sgambatti de
dc.contributor.authorZicker, Fabio
dc.contributor.authorOliveira, Renato Mauricio de
dc.contributor.authorSilva, Simone Almeida e
dc.contributor.authorLuquetti, Alejandro
dc.contributor.authorTravassos, Luiz Rodolpho [UNIFESP]
dc.contributor.authorAlmeida, Igor Correia de [UNIFESP]
dc.contributor.authorAndrade, Soraya Sgambatti de [UNIFESP]
dc.contributor.authorAndrade, João Guimarães de
dc.contributor.authorMartelli, Celina Maria Turchi
dc.date.accessioned2018-06-18T10:54:41Z
dc.date.available2018-06-18T10:54:41Z
dc.date.issued1996-11-23
dc.identifierhttp://dx.doi.org/10.1016/S0140-6736(96)04128-1
dc.identifier.citationLancet. London: Lancet Ltd, v. 348, n. 9039, p. 1407-1413, 1996.
dc.identifier.issn0140-6736
dc.identifier.urihttp://repositorio.unifesp.br/11600/44826
dc.description.abstractBackground Benznidazole, a nitroimidazole derivative, has been recommended for the treatment of acute and congenital Trypanosoma cruzi infection (Chagas' disease). We have examined the safety and efficacy of this drug in the treatment of the early chronic phase of T cruzi infection.Methods Between 1991 and 1995, we carried out a randomised, double-blind, placebo-controlled trial in a rural area of Brazil with endemic Chagas' disease. 82% of 2434 schoolchildren (aged 7-12 years) identified in a census were screened for antibodies to T cruzi by indirect immunofluorescence, indirect haemagglutination, and ELISA. 130 were positive in all tests and were randomly assigned benznidazole (7.5 mg/kg daily for 60 days by mouth) or placebo. The primary endpoint for efficacy was the disappearance of specific antibodies (negative seroconversion) by the end of 3-year follow-up. The secondary endpoint was the reduction of antibody titres on repeated serological tests. One child moved away from the area just after randomisation and was excluded from the analyses. Insecticidal measures were taken throughout the trial to reduce the risk of reinfection.Findings Minor side-effects requiring no specific medication were recorded in a small proportion of individuals. On a chemiluminescent ELISA with purified trypomastigote glycoconjugate, serum from all participants was positive at the beginning of the trial. At the end of follow-up, 37 (58%) of the 64 benznidazole-treated participants and 3 (5%) of those who received placebo were negative for T cruzi antibodies. The efficacy of benznidazole treatment estimated by intention to treat was 55.8% (95% CI 40.8-67.0). At the end of follow-up, children who received benznidazole had five-fold lower geometric mean titres by indirect immunofluorescence than placebo-treated children (196 [147-256] vs 1068 [809-1408], p<0.00001).Interpretation The trial showed that a 60-day course of benznidazole treatment of early chronic T cruzi infection was safe and 55.8% effective in producing negative seroconversion of specific antibodies. The results are very encouraging and justify the recommendation of treatment for seropositive children as public health policy.en
dc.format.extent1407-1413
dc.language.isoeng
dc.publisherLancet Ltd
dc.relation.ispartofLancet
dc.rightsAcesso restrito
dc.titleRandomised trial of efficacy of benznidazole in treatment of early Trypanosoma cruzi infectionen
dc.typeArtigo
dc.contributor.institutionUniversidade Federal de Goiás (UFG)
dc.contributor.institutionWHO
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.description.affiliationUNIV FED GOIAS,INST PATOL TROP & SAUDE PUBL,DEPT COMMUNITY HLTH,GOIANIA,GO,BRAZIL
dc.description.affiliationUNIV FED GOIAS,INST PATOL TROP & SAUDE PUBL,DEPT PARASITOL,GOIANIA,GO,BRAZIL
dc.description.affiliationUNIV FED GOIAS,INST PATOL TROP & SAUDE PUBL,DEPT TROP MED,GOIANIA,GO,BRAZIL
dc.description.affiliationWHO,PAN AMER HLTH ORG,COMMUNICABLE DIS PROGRAM,WASHINGTON,DC
dc.description.affiliationUNIV FED SAO PAULO,DEPT MICROBIOL IMMUNOL & PARASITOL,SAO PAULO,BRAZIL
dc.description.affiliationUnifespUNIV FED SAO PAULO,DEPT MICROBIOL IMMUNOL & PARASITOL,SAO PAULO,BRAZIL
dc.identifier.doi10.1016/S0140-6736(96)04128-1
dc.description.sourceWeb of Science
dc.identifier.wosWOS:A1996VU98600011


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