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

Community-acquired Pneumonia Clinical Trial

— PNEUMOPACEf  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200706
• Other study ID #: APR0127/2006
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2010
• Last updated: July 19, 2011
• Start date: November 2006
• Est. completion date: May 2011

Study information

• Verified date: September 2010
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 59 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Amoxicillin
amoxicillin 50mg/kg/day given in two different administration schemes

Locations

Country	Name	City	State
Brazil	Professor Hosannah de Oliveira Pediatric Center	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical efficacy	resolution of fever, difficulty breathing and tachypnea	48 hours	No
Secondary	Resolution of cough	Disappearance of cough	96 hours	No