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
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. This randomized (1 : 1), co...
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Published in | Journal of antimicrobial chemotherapy Vol. 69; no. 7; pp. 1954 - 1959 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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England
Oxford Publishing Limited (England)
01.07.2014
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Abstract | 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.
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. Participants were 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.
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: -5.5%-6.0%) and in 80 (20.1%) and 85 (21.3%) patients in per-protocol analysis (risk difference 1.2%; 95% CI: -4.4%-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 -0.05%; 95% CI: -9.3%-9.2%).
Oral amoxicillin (50 mg/kg/day) twice daily is as efficacious as thrice daily. |
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AbstractList | 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.
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. Participants were 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.
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: -5.5%-6.0%) and in 80 (20.1%) and 85 (21.3%) patients in per-protocol analysis (risk difference 1.2%; 95% CI: -4.4%-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 -0.05%; 95% CI: -9.3%-9.2%).
Oral amoxicillin (50 mg/kg/day) twice daily is as efficacious as thrice daily. 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. 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. Participants were 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. 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: -5.5%-6.0%) and in 80 (20.1%) and 85 (21.3%) patients in per-protocol analysis (risk difference 1.2%; 95% CI: -4.4%-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 -0.05%; 95% CI: -9.3%-9.2%). Oral amoxicillin (50 mg/kg/day) twice daily is as efficacious as thrice daily. OBJECTIVESOral 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 METHODSThis 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. Participants were 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.RESULTSFour 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: -5.5%-6.0%) and in 80 (20.1%) and 85 (21.3%) patients in per-protocol analysis (risk difference 1.2%; 95% CI: -4.4%-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 -0.05%; 95% CI: -9.3%-9.2%).CONCLUSIONSOral amoxicillin (50 mg/kg/day) twice daily is as efficacious as thrice daily. |
Author | Barral, Aldina Cardoso, Maria-Regina A Andrade, Sandra C Noblat, Lucia Nascimento-Carvalho, Cristiana M Vilas-Boas, Ana-Luisa Fontoura, Maria-Socorro H Brim, Rosa V Xavier-Souza, Gabriel Araújo-Neto, César A |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24648506$$D View this record in MEDLINE/PubMed |
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Contributor | Azevedo, Fausto Maia, José-Raimundo Nogueira, Giorgio V Gantois, Denise Fonseca, Taiane Araripe, Jamile Vilar, Ticiana Jesus, Priscila S Lorgetto, Igor Santos, Pablo M Sirmos, Uri R Araújo, Vital F Pirajá, Larissa Carneiro, Solange Silva, Carolina C Braga, Daniel A Vilas-Boas, Caroline Oliveira, Felipe Costa, Itana N Oliveira, Icaro S Câmara, Sérgio F Vieira, Júlia R Neiva, Lais B Santana, Milena C Nobre-Bastos, Monalisa Matutino, Adriana R Barreto, Bruna B |
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Copyright | The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com. Copyright Oxford Publishing Limited(England) Jul 2014 |
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Keywords | antibacterials antimicrobial therapy acute respiratory infections lower respiratory tract infection |
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References_xml | – volume: 92 start-page: 291 year: 2007 ident: key 20180328135551_DKU070C15 article-title: Comparison of standard versus double dose of amoxicillin in the treatment of non-severe pneumonia in children aged 2–59 months: a multi-centre, double blind, randomized controlled trial in Pakistan publication-title: Arch Dis Child doi: 10.1136/adc.2005.092494 contributor: fullname: Hazir – volume: 29 start-page: 203 year: 1975 ident: key 20180328135551_DKU070C6 article-title: Amoxycillin in the treatment of respiratory tract infection in children publication-title: Br J Clin Pract doi: 10.1111/j.1742-1241.1975.tb03454.x contributor: fullname: Price – volume: 83 start-page: 353 year: 2005 ident: key 20180328135551_DKU070C9 article-title: Standardized interpretation of paediatric chest radiographs for the diagnosis of pneumonia in epidemiological studies publication-title: Bull World Health Organ contributor: fullname: Cherian – volume: 364 start-page: 1141 year: 2004 ident: key 20180328135551_DKU070C14 article-title: Oral amoxicillin versus injectable penicillin for severe pneumonia in children aged 3 to 59 months: a randomized multicentre equivalency study publication-title: Lancet doi: 10.1016/S0140-6736(04)17100-6 contributor: fullname: Addo-Yobo – volume: 86 start-page: 408 year: 2008 ident: key 20180328135551_DKU070C3 article-title: Epidemiology and etiology of childhood pneumonia publication-title: Bull World Health Organ doi: 10.2471/BLT.07.048769 contributor: fullname: Rudan – volume: 53 start-page: 25 year: 2011 ident: key 20180328135551_DKU070C4 article-title: The management of community-acquired pneumonia in infants and children older than 3 months of age: clinical practice guidelines by Pediatric Infectious Diseases Society and Infectious Diseases Society of America publication-title: Clin Infect Dis doi: 10.1093/cid/cir531 contributor: fullname: Bradley – volume: 24 start-page: 477 year: 2004 ident: key 20180328135551_DKU070C18 article-title: Application of pharmacokinetics and pharmacodynamics to antimicrobial therapy of respiratory tract infections publication-title: Clin Lab Med doi: 10.1016/j.cll.2004.03.009 contributor: fullname: Andes – volume: 52 start-page: 293 year: 2011 ident: key 20180328135551_DKU070C16 article-title: Comparison of oral amoxicillin with placebo for the treatment of World Health Organization-defined nonsevere pneumonia in children aged 2–59 months: a multicenter, double-blind, randomized, placebo-controlled trial in Pakistan publication-title: Clin Infect Dis doi: 10.1093/cid/ciq142 contributor: fullname: Hazir – volume: 32 start-page: 1281 year: 2013 ident: key 20180328135551_DKU070C2 article-title: Review of guidelines for evidence-based management for childhood community-acquired pneumonia in under-5 years from developed and developing countries publication-title: Pediatr Infect Dis J doi: 10.1097/INF.0b013e3182a4dcfa contributor: fullname: Nascimento-Carvalho – volume-title: Training Course on Child Growth Assessment year: 2008 ident: key 20180328135551_DKU070C8 contributor: fullname: WHO – volume: 47 start-page: 129 year: 2001 ident: key 20180328135551_DKU070C17 article-title: Evidence to support the rationale that bacterial eradication in respiratory tract infection is an important aim of antimicrobial therapy publication-title: J Antimicrob Chemother doi: 10.1093/jac/47.2.129 contributor: fullname: Dagan – volume-title: Fundamentals of Clinical Trials year: 1996 ident: key 20180328135551_DKU070C12 contributor: fullname: Friedman – volume: 15 start-page: 380 year: 2004 ident: key 20180328135551_DKU070C10 article-title: Recommendation of the Brazilian Society of Pediatrics for antibiotic therapy in children and adolescents with community-acquired pneumonia publication-title: Pan Am J Public Health doi: 10.1590/S1020-49892004000600003 contributor: fullname: Nascimento-Carvalho – volume: 3 start-page: e1991 year: 2008 ident: key 20180328135551_DKU070C22 article-title: Does 3-day course of oral amoxycillin benefit children of non-severe pneumonia with wheeze: a multicentric randomized controlled trial publication-title: PLoS ONE doi: 10.1371/journal.pone.0001991 contributor: fullname: Awasthi – volume-title: Pocket Book of Hospital Care for Children: Guidelines for the Management of Common Childhood Illnesses year: 2013 ident: key 20180328135551_DKU070C5 contributor: fullname: WHO – volume: 28 start-page: e265 year: 2009 ident: key 20180328135551_DKU070C20 article-title: Laboratory-based surveillance of Streptococcus pneumoniae invasive disease in children in 10 Latin American countries: a SIREVA II project, 2000–2005 publication-title: Pediatr Infect Dis J doi: 10.1097/INF.0b013e3181a74b22 contributor: fullname: Castañeda – volume: 10 start-page: 924 year: 2006 ident: key 20180328135551_DKU070C21 article-title: Can WHO therapy failure criteria for non-severe pneumonia be improved in children aged 2–59 months? publication-title: Int J Tuberc Lung Dis contributor: fullname: Hazir – volume: 49 start-page: 897 year: 2002 ident: key 20180328135551_DKU070C7 article-title: Patient compliance with antibiotic treatment for respiratory tract infections publication-title: J Antimicrob Chemother doi: 10.1093/jac/dkf046 contributor: fullname: Kardas – volume: 360 start-page: 835 year: 2002 ident: key 20180328135551_DKU070C13 article-title: Clinical efficacy of 3 days versus 5 days of oral amoxicillin for treatment of childhood pneumonia: a multicentre double-blind trial publication-title: Lancet doi: 10.1016/S0140-6736(02)09994-4 contributor: fullname: Pakistan Multicentre Amoxycillin Short Course Therapy (MASCOT) pneumonia study group – volume-title: Performance Standards for Antimicrobial Susceptibility Testing: Twenty-fourth Informational Supplement M100-S24 year: 2014 ident: key 20180328135551_DKU070C19 contributor: fullname: Clinical and Laboratory Standards Institute – volume: 381 start-page: 1405 year: 2013 ident: key 20180328135551_DKU070C1 article-title: Global burden of childhood pneumonia and diarrhea publication-title: Lancet doi: 10.1016/S0140-6736(13)60222-6 contributor: fullname: Walker – volume: 91 start-page: 351 year: 2006 ident: key 20180328135551_DKU070C11 article-title: Thermometry in paediatric practice publication-title: Arch Dis Child doi: 10.1136/adc.2005.088831 contributor: fullname: El-Radhi |
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Snippet | 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... OBJECTIVESOral amoxicillin (50 mg/kg/day) thrice daily is the first-line therapy for non-severe childhood pneumonia. Compliance could be enhanced if two daily... |
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SubjectTerms | Administration, Oral Amoxicillin - administration & dosage Anti-Bacterial Agents - administration & dosage Antibiotics Bacterial infections Brazil Child, Preschool Female Humans Infant Male Medical treatment Pneumonia, Bacterial - drug therapy Respiratory diseases Respiratory distress syndrome Treatment Outcome |
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 |
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