Clinical trial NCT01200706: Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia
Official title: Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Community-acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Community-acquired Pneumonia
Keywords: children aged under 5 years
Non-severe
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 820
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe community-acquired pneumonia.


Eligibility criteria: Inclusion Criteria:

* Children aged between 2 and 59 months
* Report of respiratory complaints
* Presence of pulmonary infiltrate on chest x-ray taken on admission and read by the pediatrician on duty

Exclusion Criteria:

* lower chest indrawing
* danger signs (inability to drink, convulsions, somnolence, central cyanosis, grunting in a calm child)
* diagnosed underlying chronic diseases (anatomic abnormalities of the respiratory tract, chronic pulmonary illness besides asthma, immunological defects, progressing neurological disorders, psychomotor retardation, heart disease with clinical repercussion, hemoglobinopathy, liver or kidney disease)
* severe malnutrition
* other concurrent infection
* hospitalization during the previous 7 days
* amoxicillin or similar antibiotic use during the last 48 hours
* allergy to amoxicillin
* history of aspiration

Primary outcomes:
measure: clinical efficacy
timeFrame: 48 hours
Secondary outcomes:
measure: Resolution of cough
timeFrame: 96 hours
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Professor Hosannah de Oliveira Pediatric Center
state: Bahia
Study officials:
affiliation: Federal University of Bahia School of Medicine
name: Cristiana M Nascimento-Carvalho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nascimento-Carvalho AC, Vilas-Boas AL, Fontoura MH, Vuorinen T, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. Respiratory viruses among children with non-severe community-acquired pneumonia: A prospective cohort study. J Clin Virol. 2018 Aug;105:77-83. doi: 10.1016/j.jcv.2018.06.003. Epub 2018 Jun 6.
citation: Nascimento-Carvalho AC, Vilas-Boas AL, Fontoura MH, Xu M, Vuorinen T, Soderlund-Venermo M, Ruuskanen O, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. Serologically diagnosed acute human bocavirus 1 infection in childhood community-acquired pneumonia. Pediatr Pulmonol. 2018 Jan;53(1):88-94. doi: 10.1002/ppul.23891. Epub 2017 Oct 13.
citation: Nascimento-Carvalho CM, Xavier-Souza G, Vilas-Boas AL, Fontoura MH, Barral A, Puolakkainen M, Ruuskanen O; PNEUMOPAC-Efficacy Study Group. Evolution of acute infection with atypical bacteria in a prospective cohort of children with community-acquired pneumonia receiving amoxicillin. J Antimicrob Chemother. 2017 Aug 1;72(8):2378-2384. doi: 10.1093/jac/dkx126.
citation: Vilas-Boas AL, Fontoura MS, Xavier-Souza G, Araujo-Neto CA, Andrade SC, Brim RV, Noblat L, Barral A, Cardoso MR, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. 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. J Antimicrob Chemother. 2014 Jul;69(7):1954-9. doi: 10.1093/jac/dku070. Epub 2014 Mar 19.
citation: Xavier-Souza G, Vilas-Boas AL, Fontoura MS, Araujo-Neto CA, Andrade SC, Cardoso MR, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. The inter-observer variation of chest radiograph reading in acute lower respiratory tract infection among children. Pediatr Pulmonol. 2013 May;48(5):464-9. doi: 10.1002/ppul.22644. Epub 2012 Aug 8.