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

Primary Purpose

Community-acquired Pneumonia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Amoxicillin
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring children aged under 5 years, Non-severe

Eligibility Criteria

2 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Professor Hosannah de Oliveira Pediatric Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Amoxicillin given twice a day

Amoxicillin given three times a day

Arm Description

Outcomes

Primary Outcome Measures

clinical efficacy
resolution of fever, difficulty breathing and tachypnea

Secondary Outcome Measures

Resolution of cough
Disappearance of cough

Full Information

First Posted
September 13, 2010
Last Updated
July 19, 2011
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT01200706
Brief Title
Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia
Acronym
PNEUMOPACEf
Official Title
Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Community-acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Bahia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
children aged under 5 years, Non-severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
820 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin given twice a day
Arm Type
Active Comparator
Arm Title
Amoxicillin given three times a day
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Placebo with amoxicillin,in the opposite posologic scheme
Intervention Description
amoxicillin 50mg/kg/day given in two different administration schemes
Primary Outcome Measure Information:
Title
clinical efficacy
Description
resolution of fever, difficulty breathing and tachypnea
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Resolution of cough
Description
Disappearance of cough
Time Frame
96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiana M Nascimento-Carvalho, MD, PhD
Organizational Affiliation
Federal University of Bahia School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professor Hosannah de Oliveira Pediatric Center
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40160-170
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29908521
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.
Results Reference
derived
PubMed Identifier
29028159
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.
Results Reference
derived
PubMed Identifier
28475737
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.
Results Reference
derived
PubMed Identifier
24648506
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.
Results Reference
derived
PubMed Identifier
22888091
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.
Results Reference
derived

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

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