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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01200706
Acronym
PNEUMOPACEf
Enrollment
820
Registered
2010-09-14
Start date
2006-11-30
Completion date
2011-05-31
Last updated
2011-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Keywords

children aged under 5 years, Non-severe

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.

Interventions

DRUGAmoxicillin

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

Sponsors

Federal University of Bahia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Months to 59 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
clinical efficacy48 hoursresolution of fever, difficulty breathing and tachypnea

Secondary

MeasureTime frameDescription
Resolution of cough96 hoursDisappearance of cough

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026