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

Phase 4
Completed
Conditions
Community-acquired Pneumonia
Interventions
Registration Number
NCT01200706
Lead Sponsor
Federal University of Bahia
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
820
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Amoxicillin given twice a dayAmoxicillin-
Amoxicillin given three times a dayAmoxicillin-
Primary Outcome Measures
NameTimeMethod
clinical efficacy48 hours

resolution of fever, difficulty breathing and tachypnea

Secondary Outcome Measures
NameTimeMethod
Resolution of cough96 hours

Disappearance of cough

Trial Locations

Locations (1)

Professor Hosannah de Oliveira Pediatric Center

🇧🇷

Salvador, Bahia, Brazil

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