Ana-Luisa Vilas-Boas1, Maria-Socorro H Fontoura1, Gabriel Xavier-Souza1, César A Araújo-Neto2, Sandra C Andrade3, Rosa V Brim2, Lucia Noblat4, Aldina Barral5, Maria-Regina A Cardoso6, Cristiana M Nascimento-Carvalho7. 1. Department of Paediatrics, Federal University of Bahia School of Medicine, Salvador, Brazil. 2. Department of Image Diagnosis, Federal University of Bahia School of Medicine, Salvador, Brazil. 3. Image Diagnosis Unit, Federal University of Bahia Hospital, Salvador, Brazil. 4. Pharmacy Unit, Federal University of Bahia Hospital, Salvador, Brazil. 5. Pathology Department, Federal University of Bahia School of Medicine and Centro de Pesquisa Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Brazil. 6. Department of Epidemiology, University of São Paulo School of Public Health, São Paulo, Brazil. 7. Department of Paediatrics, Federal University of Bahia School of Medicine, Salvador, Brazil nascimentocarvalho@hotmail.com.
Abstract
OBJECTIVES: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. 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. RESULTS:Four hundred and twelve and 408 participants receivedamoxicillin 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%). CONCLUSIONS:Oral amoxicillin (50 mg/kg/day) twice daily is as efficacious as thrice daily.
RCT Entities:
OBJECTIVES: 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. 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. 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: -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%). CONCLUSIONS: Oral amoxicillin (50 mg/kg/day) twice daily is as efficacious as thrice daily.
Authors: I C Borges; D C Andrade; A-L Vilas-Boas; M-S H Fontoura; H Laitinen; N Ekström; P V Adrian; A Meinke; M-R A Cardoso; A Barral; O Ruuskanen; H Käyhty; C M Nascimento-Carvalho Journal: Eur J Clin Microbiol Infect Dis Date: 2015-04-19 Impact factor: 3.267
Authors: Amanda C Nascimento-Carvalho; Ana-Luisa Vilas-Boas; Maria-Socorro H Fontoura; Man Xu; Tytti Vuorinen; Maria Söderlund-Venermo; Olli Ruuskanen; Cristiana M Nascimento-Carvalho Journal: Pediatr Pulmonol Date: 2017-10-13