Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia

NCT01200706 | Completed Phase 4

• 1 other identifier: APR0127/2006
• Study Type: interventional
• Target: 820
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Pneumonia

Keywords

children aged under 5 years; Non-severe

Outcome Measures

Primary Outcomes (1)

• clinical efficacy

  resolution of fever, difficulty breathing and tachypnea

  48 hours

Secondary Outcomes (1)

• Resolution of cough

  96 hours

Study Arms (2)

Amoxicillin given twice a day

ACTIVE COMPARATOR

Drug: Amoxicillin

Amoxicillin given three times a day

ACTIVE COMPARATOR

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

amoxicillin 50mg/kg/day given in two different administration schemes

Also known as: Placebo with amoxicillin,in the opposite posologic scheme

Amoxicillin given three times a day; Amoxicillin given twice a day

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Professor Hosannah de Oliveira Pediatric Center

Salvador, Estado de Bahia, 40160-170, Brazil

Location

Related Publications (5)

• 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.

  PMID: 29908521 DERIVED

• 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.

  PMID: 29028159 DERIVED

• 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.

  PMID: 28475737 DERIVED

• 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.

  PMID: 24648506 DERIVED

• 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.

  PMID: 22888091 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Cristiana M Nascimento-Carvalho, MD, PhD

  Federal University of Bahia School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: November 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2010-09

Locations

BR (1)