Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:
NCT01875731
First received: June 10, 2013
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in children with non severe community acquired pneumonia (CAP) and pneumoccocal vaccine will reduce antibiotic use as compared to standard care practice (current guidelines for CAP).


Condition Intervention
Community Acquired Pneumonia
Behavioral: BPS
Behavioral: Guideline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Efficacy of BPS (Bacterial Pneumonia Score) Guided Antibiotic Use in Children With Community Acquired Pneumonia on Reducing Antibiotic Use as Compared to Standard Care Practice (Current Guidelines for CAP) in the Era of Pneumococcal Vaccine

Resource links provided by NLM:


Further study details as provided by Hospital General de Niños Pedro de Elizalde:

Primary Outcome Measures:
  • Use of Antibiotics in Each Group [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Initial use of any antibiotic, immediately after diagnosis


Secondary Outcome Measures:
  • Treatment Failure in Each Group [ Time Frame: 1, 2, 5, 7 and 10 days from baseline ] [ Designated as safety issue: Yes ]
    Persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm. after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.


Estimated Enrollment: 60
Study Start Date: July 2013
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BPS
Strategy based on BPS guided antibiotic use
Behavioral: BPS
In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
Active Comparator: Guideline
Strategy based on enforced guideline guided antibiotic use
Behavioral: Guideline
Strategy based on enforced guideline guided antibiotic use

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 3-60 months assisted as outpatients for non severe community acquired pneumonia and pneumoccocal vaccine and complete immunisation with pneumoccocal vaccine.

Exclusion Criteria:

  • Wheezing
  • Severe pneumonia
  • Pulmonary or cardiovascular chronic disease
  • Antibiotic use in the previous two weeks
  • Hospitalization for any reason in the previous two weeks
  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: NCT01875731

Locations
Argentina
Hospital General de NIños Pedro de Elizalde
Buenos Aires, CF, Argentina, C1270AAN
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
Principal Investigator: Fernando A Torres, MD, PhD Hospital de Niños Pedro de Elizalde
  More Information

Publications:
Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01875731     History of Changes
Other Study ID Numbers: HGNPE 67-2012
Study First Received: June 10, 2013
Last Updated: July 11, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital General de Niños Pedro de Elizalde:
Pneumonia
Acute respiratory infection
Decision-support techniques

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

ClinicalTrials.gov processed this record on September 16, 2014