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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200706
First Posted: September 14, 2010
Last Update Posted: July 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of Bahia
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    resolution of fever, difficulty breathing and tachypnea


Secondary Outcome Measures:
  • Resolution of cough [ Time Frame: 96 hours ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: September 13, 2010
First Posted: September 14, 2010
Last Update Posted: July 20, 2011
Last Verified: September 2010

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