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

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.
 
ClinicalTrials.gov Identifier: NCT01200706
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Federal University of Bahia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Amoxicillin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
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
Study Start Date : November 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. clinical efficacy [ Time Frame: 48 hours ]
    resolution of fever, difficulty breathing and tachypnea


Secondary Outcome Measures :
  1. Resolution of cough [ Time Frame: 96 hours ]
    Disappearance of cough


Eligibility Criteria
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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
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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
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Brazil
Professor Hosannah de Oliveira Pediatric Center
Salvador, Bahia, Brazil, 40160-170
Sponsors and Collaborators
Federal University of Bahia
Investigators
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Principal Investigator: Cristiana M Nascimento-Carvalho, MD, PhD Federal University of Bahia School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Cristiana Maria Costa Nascimento-Carvalho, Federal University of Bahia School of Medicine
ClinicalTrials.gov Identifier: NCT01200706    
Other Study ID Numbers: APR0127/2006
First Posted: September 14, 2010    Key Record Dates
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:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents