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

This study has been completed.
Sponsor:
Information provided by:
Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT01200706
First received: September 13, 2010
Last updated: July 19, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Community-acquired Pneumonia
Drug: Amoxicillin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Community-acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:
  • clinical efficacy [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    resolution of fever, difficulty breathing and tachypnea


Secondary Outcome Measures:
  • Resolution of cough [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
    Disappearance of cough


Enrollment: 820
Study Start Date: November 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amoxicillin given twice a day Drug: Amoxicillin
amoxicillin 50mg/kg/day given in two different administration schemes
Other Name: Placebo with amoxicillin,in the opposite posologic scheme
Active Comparator: Amoxicillin given three times a day Drug: Amoxicillin
amoxicillin 50mg/kg/day given in two different administration schemes
Other Name: Placebo with amoxicillin,in the opposite posologic scheme

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200706

Locations
Brazil
Professor Hosannah de Oliveira Pediatric Center
Salvador, Bahia, Brazil, 40160-170
Sponsors and Collaborators
Federal University of Bahia
Investigators
Principal Investigator: Cristiana M Nascimento-Carvalho, MD, PhD Federal University of Bahia School of Medicine
  More Information

No publications provided

Responsible Party: Prof. Cristiana Maria Costa Nascimento-Carvalho, Federal University of Bahia School of Medicine
ClinicalTrials.gov Identifier: NCT01200706     History of Changes
Other Study ID Numbers: APR0127/2006
Study First Received: September 13, 2010
Last Updated: July 19, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Bahia:
children aged under 5 years
Non-severe

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014