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

F

Federal University of Bahia

Status and phase

Completed
Phase 4

Conditions

Community-acquired Pneumonia

Treatments

Drug: Amoxicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT01200706
APR0127/2006

Details and patient eligibility

About

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.

Enrollment

820 patients

Sex

All

Ages

2 to 59 months old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

820 participants in 2 patient groups

Amoxicillin given twice a day
Active Comparator group
Treatment:
Drug: Amoxicillin
Amoxicillin given three times a day
Active Comparator group
Treatment:
Drug: Amoxicillin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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