Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial

Detalhes bibliográficos
Autor(a) principal: Vilas-Boas, Ana Luisa
Data de Publicação: 2014
Outros Autores: Fontoura, Maria do Socorro Heitz, Souza, Gabriel Xavier, Araújo Neto, César Augusto de, Andrade, Sandra C, Brim, Rosa V, Noblat, Lucia, Barral, Aldina Maria Prado, Cardoso, Maria Regina Alves, Carvalho, Cristiana Maria Costa Nascimento, Pneumopac-Efficacy Study Group
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/7857
Resumo: Federal University of Bahia. School of Medicine. Department of Paediatrics. Salvador, BA, Brasil
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spelling Vilas-Boas, Ana LuisaFontoura, Maria do Socorro HeitzSouza, Gabriel XavierAraújo Neto, César Augusto deAndrade, Sandra CBrim, Rosa VNoblat, LuciaBarral, Aldina Maria PradoCardoso, Maria Regina AlvesCarvalho, Cristiana Maria Costa NascimentoPneumopac-Efficacy Study Group2014-06-30T17:58:15Z2014-06-30T17:58:15Z2014VILAS-BOAS, A. L. et al. Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial. Journal of Antimicrobial Chemotherapy, v. 69, n. 7, p. 1954–1959, 2014.0305-7453https://www.arca.fiocruz.br/handle/icict/785710.1093/jac/dku070engOxford University PressComparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFederal University of Bahia. School of Medicine. Department of Paediatrics. Salvador, BA, BrasilFederal University of Bahia. School of Medicine. Department of Paediatrics. Salvador, BA, BrasilFederal University of Bahia. School of Medicine. Department of Paediatrics. Salvador, BA, BrasilUniversity Federal of Bahia School of Medicine. Department of Image Diagnosis. Salvador, BA, BrasilFederal University of Bahia Hospital. Image Diagnosis Unit. Salvador, BA, BrasilUniversity Federal of Bahia School of Medicine. Department of Image Diagnosis. Salvador, BA, BrasilFederal University of Bahia Hospital. Pharmacy Unit. Salvador, BA, BrasilFederal University of Bahia School of Medicine. Pathology Department. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisa Gonçalo Moniz. Salvador, BA, BrasilUniversity of São Paulo School of Public Health. Department of Epidemiology. São Paulo, SP, BrasilUniversity of São Paulo School of Public Health. Department of Epidemiology. São Paulo, SP, BrasilFederal University of Bahia. School of Medicine. Department of Paediatrics. Salvador, BA, BrasilObjectives: Oral amoxicillin (50 mg/kg/day) thrice daily is the first-line therapy for non-severe childhood pneumonia. Compliance could be enhanced if two daily doses are employed. We assessed the equivalence of oral amoxicillin (50 mg/kg/day) thrice or twice daily in those patients. Patients and methods: This randomized (1: 1), controlled, triple-blinded investigation conducted at one centre in Brazil included children aged 2–59 months with non-severe pneumonia diagnosed by trained paediatricians based on respiratory complaints and radiographic pulmonary infiltrate/consolidation. Participantswere randomly assigned to receive one bottle (Amoxicillin 1) at 6 am, 2 pm and 10 pm and the other bottle (Amoxicillin 2) at 8 am and 8 pm: one bottle contained amoxicillin and the other placebo and vice versa. Only the pharmacist knew patients’ allocation. Follow-up assessments were done at 2, 5 and 14 days after enrolment. Chest radiographs were read by three independent radiologists. Primary outcome was treatment failure (development of danger signs, persistence of fever, tachypnoea, development of serious adverse reactions, death and withdrawal from the trial) at 48 h. ClinicalTrials.gov: identifier NCT01200706. Results: Four hundred and twelve and 408 participants received amoxicillin thrice or twice daily, respectively. Treatment failure was detected in 94 (22.8%) and 94 (23.0%) patients in intention-to-treat analysis (risk difference 0.2%; 95% CI: 25.5%–6.0%) and in 80 (20.1%) and 85 (21.3%) patients in per-protocol analysis (risk difference 1.2%; 95% CI: 24.4%–6.8%). Pneumonia was radiologically confirmed by concordant reading in 277 (33.8%) cases, among whom treatment failure was registered in 25/133 (18.8%) and 27/144 (18.8%) participants from the thrice and twice daily doses subgroups, respectively (risk difference 20.05%; 95% CI: 29.3%– 9.2%). Conclusions: Oral amoxicillin (50 mg/kg/day) twice daily is as efficacious as thrice daily.Acute respiratory infectionsAntibacterialsAntimicrobial therapyLower respiratory tract infectioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALVilas-Boas AL Comparison of oral....pdfVilas-Boas AL Comparison of oral....pdfapplication/pdf192137https://www.arca.fiocruz.br/bitstream/icict/7857/1/Vilas-Boas%20AL%20Comparison%20of%20oral....pdfc8cc369ee368a9bdb6e9eedde3f9fbabMD51LICENSElicense.txtlicense.txttext/plain; charset=utf-81914https://www.arca.fiocruz.br/bitstream/icict/7857/2/license.txt7d48279ffeed55da8dfe2f8e81f3b81fMD52TEXTVilas-Boas AL Comparison of oral....pdf.txtVilas-Boas AL Comparison of oral....pdf.txtExtracted texttext/plain31909https://www.arca.fiocruz.br/bitstream/icict/7857/3/Vilas-Boas%20AL%20Comparison%20of%20oral....pdf.txtc87a1e11f53021c0db9a0b90d810afacMD53icict/78572023-03-15 14:33:19.57oai:www.arca.fiocruz.br:icict/7857TElDRU7Dh0EgREUgRElTVFJJQlVJw4fDg08gTsODTy1FWENMVVNJVkEKCkFvIGNvbmNvcmRhciBlIGFjZWl0YXIgZXN0YSBsaWNlbsOnYSB2b2PDqiAoYXV0b3Igb3UgZGV0ZW50b3IgZG9zIGRpcmVpdG9zIGF1dG9yYWlzKToKCmEpIERlY2xhcmEgcXVlIGNvbmhlY2UgYSBwb2zDrXRpY2EgZGUgY29weXJpZ2h0IGRhIGVkaXRvcmEgZG8gc2V1IGRvY3VtZW50by4KCmIpIERlY2xhcmEgcXVlIGNvbmhlY2UgZSBhY2VpdGEgYXMgRGlyZXRyaXplcyBwYXJhIG8gUmVwb3NpdMOzcmlvIEluc3RpdHVjaW9uYWwgZGEgRnVuZGHDp8OjbyBPc3dhbGRvIENydXogKEZJT0NSVVopLgoKYykgQ29uY2VkZSDDoCBGSU9DUlVaIG8gZGlyZWl0byBuw6NvLWV4Y2x1c2l2byBkZSBhcnF1aXZhciwgcmVwcm9kdXppciwgY29udmVydGVyIChjb21vIGRlZmluaWRvIGEgc2VndWlyKSwgY29tdW5pY2FyCiAKZS9vdSBkaXN0cmlidWlyIG5vIFJlcG9zaXTDs3JpbyBkYSBGSU9DUlVaLCBvIGRvY3VtZW50byBlbnRyZWd1ZSAoaW5jbHVpbmRvIG8gcmVzdW1vL2Fic3RyYWN0KSBlbSBmb3JtYXRvIGRpZ2l0YWwgb3UgCgpwb3IgcXVhbHF1ZXIgb3V0cm8gbWVpby4KCmQpIERlY2xhcmEgcXVlIGF1dG9yaXphIGEgRklPQ1JVWiBhIGFycXVpdmFyIG1haXMgZGUgdW1hIGPDs3BpYSBkZXN0ZSBkb2N1bWVudG8gZSBjb252ZXJ0w6otbG8sIHNlbSBhbHRlcmFyIG8gc2V1IGNvbnRlw7pkbywgCgpwYXJhIHF1YWxxdWVyIGZvcm1hdG8gZGUgYXJxdWl2bywgbWVpbyBvdSBzdXBvcnRlLCBwYXJhIGVmZWl0b3MgZGUgc2VndXJhbsOnYSwgcHJlc2VydmHDp8OjbyAoYmFja3VwKSBlIGFjZXNzby4KCmUpIERlY2xhcmEgcXVlIG8gZG9jdW1lbnRvIHN1Ym1ldGlkbyDDqSBvIHNldSB0cmFiYWxobyBvcmlnaW5hbCwgZSBxdWUgZGV0w6ltIG8gZGlyZWl0byBkZSBjb25jZWRlciBhIHRlcmNlaXJvcyBvcyBkaXJlaXRvcyAKCmNvbnRpZG9zIG5lc3RhIGxpY2Vuw6dhLiBEZWNsYXJhIHRhbWLDqW0gcXVlIGEgZW50cmVnYSBkbyBkb2N1bWVudG8gbsOjbyBpbmZyaW5nZSBvcyBkaXJlaXRvcyBkZSBxdWFscXVlciBvdXRyYSBwZXNzb2Egb3UgZW50aWRhZGUuCgpmKSBEZWNsYXJhIHF1ZSwgbm8gY2FzbyBkbyBkb2N1bWVudG8gc3VibWV0aWRvIGNvbnRlciBtYXRlcmlhbCBkbyBxdWFsIG7Do28gZGV0w6ltIG9zIGRpcmVpdG9zIGRlIGF1dG9yLCBvYnRldmUgYSBhdXRvcml6YcOnw6NvIAoKaXJyZXN0cml0YSBkbyByZXNwZWN0aXZvIGRldGVudG9yIGRlc3NlcyBkaXJlaXRvcywgcGFyYSBjZWRlciBhIEZJT0NSVVogb3MgZGlyZWl0b3MgcmVxdWVyaWRvcyBwb3IgZXN0YSBMaWNlbsOnYSBlIGF1dG9yaXphciBhIAoKdXRpbGl6w6EtbG9zIGxlZ2FsbWVudGUuIERlY2xhcmEgdGFtYsOpbSBxdWUgZXNzZSBtYXRlcmlhbCBjdWpvcyBkaXJlaXRvcyBzw6NvIGRlIHRlcmNlaXJvcyBlc3TDoSBjbGFyYW1lbnRlIGlkZW50aWZpY2FkbyBlIHJlY29uaGVjaWRvIAoKbm8gdGV4dG8gb3UgY29udGXDumRvIGRvIGRvY3VtZW50byBlbnRyZWd1ZS4KCmcpIFNFIE8gRE9DVU1FTlRPIEVOVFJFR1VFIMOJIEJBU0VBRE8gRU0gVFJBQkFMSE8gRklOQU5DSUFETyBPVSBBUE9JQURPIFBPUiBPVVRSQSBJTlNUSVRVScOHw4NPIFFVRSBOw4NPIEEgRklPQ1JVWiwgREVDTEFSQSBRVUUgQ1VNUFJJVSAKClFVQUlTUVVFUiBPQlJJR0HDh8OVRVMgRVhJR0lEQVMgUEVMTyBSRVNQRUNUSVZPIENPTlRSQVRPIE9VIEFDT1JETy4gQSBGSU9DUlVaIGlkZW50aWZpY2Fyw6EgY2xhcmFtZW50ZSBvKHMpIG5vbWUocykgZG8ocykgYXV0b3IoZXMpIGRvcyAKCmRpcmVpdG9zIGRvIGRvY3VtZW50byBlbnRyZWd1ZSBlIG7Do28gZmFyw6EgcXVhbHF1ZXIgYWx0ZXJhw6fDo28sIHBhcmEgYWzDqW0gZG8gcHJldmlzdG8gbmEgYWzDrW5lYSBjKS4KRepositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-03-15T17:33:19Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
title Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
spellingShingle Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
Vilas-Boas, Ana Luisa
Acute respiratory infections
Antibacterials
Antimicrobial therapy
Lower respiratory tract infection
title_short Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
title_full Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
title_fullStr Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
title_full_unstemmed Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
title_sort Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial
author Vilas-Boas, Ana Luisa
author_facet Vilas-Boas, Ana Luisa
Fontoura, Maria do Socorro Heitz
Souza, Gabriel Xavier
Araújo Neto, César Augusto de
Andrade, Sandra C
Brim, Rosa V
Noblat, Lucia
Barral, Aldina Maria Prado
Cardoso, Maria Regina Alves
Carvalho, Cristiana Maria Costa Nascimento
Pneumopac-Efficacy Study Group
author_role author
author2 Fontoura, Maria do Socorro Heitz
Souza, Gabriel Xavier
Araújo Neto, César Augusto de
Andrade, Sandra C
Brim, Rosa V
Noblat, Lucia
Barral, Aldina Maria Prado
Cardoso, Maria Regina Alves
Carvalho, Cristiana Maria Costa Nascimento
Pneumopac-Efficacy Study Group
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Vilas-Boas, Ana Luisa
Fontoura, Maria do Socorro Heitz
Souza, Gabriel Xavier
Araújo Neto, César Augusto de
Andrade, Sandra C
Brim, Rosa V
Noblat, Lucia
Barral, Aldina Maria Prado
Cardoso, Maria Regina Alves
Carvalho, Cristiana Maria Costa Nascimento
Pneumopac-Efficacy Study Group
dc.subject.en.pt_BR.fl_str_mv Acute respiratory infections
Antibacterials
Antimicrobial therapy
Lower respiratory tract infection
topic Acute respiratory infections
Antibacterials
Antimicrobial therapy
Lower respiratory tract infection
description Federal University of Bahia. School of Medicine. Department of Paediatrics. Salvador, BA, Brasil
publishDate 2014
dc.date.accessioned.fl_str_mv 2014-06-30T17:58:15Z
dc.date.available.fl_str_mv 2014-06-30T17:58:15Z
dc.date.issued.fl_str_mv 2014
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv VILAS-BOAS, A. L. et al. Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial. Journal of Antimicrobial Chemotherapy, v. 69, n. 7, p. 1954–1959, 2014.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/7857
dc.identifier.issn.none.fl_str_mv 0305-7453
dc.identifier.doi.none.fl_str_mv 10.1093/jac/dku070
identifier_str_mv VILAS-BOAS, A. L. et al. Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial. Journal of Antimicrobial Chemotherapy, v. 69, n. 7, p. 1954–1959, 2014.
0305-7453
10.1093/jac/dku070
url https://www.arca.fiocruz.br/handle/icict/7857
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
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