Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Community Acquired Pneumonia
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Strategy based on BPS guided antibiotic use
Enforced Guidelines
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia focused on measuring Pneumonia, Children
Eligibility Criteria
Inclusion Criteria:
- Children aged 3-60 months assisted as outpatients for non severe community acquired pneumonia.
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
Sites / Locations
- Hospital General de Niños Pedro de Elizalde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BPS
Guideline
Arm Description
BPS guidance
Enforced guidelines
Outcomes
Primary Outcome Measures
Use of Antibiotics in Each Group
The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).
Secondary Outcome Measures
Treatment Failure in Each Group
Treatment failure was defined as: 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.
Proportion of patients with treatment failure was compared between both groups (BPS vs Guideline).
Full Information
NCT ID
NCT01041209
First Posted
December 30, 2009
Last Updated
November 7, 2016
Sponsor
Hospital General de Niños Pedro de Elizalde
1. Study Identification
Unique Protocol Identification Number
NCT01041209
Brief Title
Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Community Acquired Pneumonia
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General de Niños Pedro de Elizalde
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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) will reduce antibiotic use as compared to standard care practice (current guidelines for CAP).
Detailed Description
Background: Pneumonia is a leading cause of mortality in children. Despite more than 50% of pneumonias are due to viruses, because it is difficult to rule out bacterial etiology, initial management of pneumonia in children usually includes antibiotics, often unnecessary. In 2006 was designed and validated a clinical prediction rule (BPS: Bacterial Pneumonia Score) which accurately identifies hospitalized children's risk of bacterial pneumonia. However, BPS efficacy on guiding therapeutic decision in children with community acquired pneumonia (CAP) has not been yet assessed.
Aim: The aim of this study is to test if BPS guided antibiotic use in children with non severe community acquired pneumonia will reduce antibiotic use as compared to standard care practice (current guidelines for CAP) Design: This is a randomized, controlled, blinded trial, to assess antibiotics use regarding two methods for initial management of children aged 3-60 months with non severe community acquired pneumonia. Children will be randomly allocate to be managed according to BPS or currently enforced guidelines. Use of antibiotics (%) and clinical outcome of both groups will be compared.
Setting: Tertiary children hospital in Buenos Aires, Argentina. Patients: Consecutive children aged 3-60 months assisted for non severe community acquired pneumonia as outpatients. Patients with wheezing, severe pneumonia, pulmonary or cardiovascular chronic disease, or antibiotic use or hospitalization in the previous two weeks will be excluded.
Endpoints:
Primary: Use of antibiotics in each group (proportion) Secondary: Treatment failure (proportion) in each group Endpoints will be assessed at baseline and after 1, 2, 5, 7 and 10 days by a blinded investigator.
Intervention: Patients with CAP will be randomized (1:1) to BPS versus enforced guidelines. In the BPS group antibiotics will be indicated in patients with a BPS ≥ 4 points, while in the control group antibiotics will be indicated according to current guidelines.
Variables and measurement: Antibiotic use will be defined as initial use of any antibiotic, immediately after diagnosis. Treatment failure will be defined as 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.
Study hypothesis: BPS antibiotic use guidance will reduce at least 20% antibiotic use, as compared to standard care practice.
Analyses: These will be done based on an intention-to-treat and a per-protocol principle. With an assumed 20% less use of antibiotics in the intervention group, a maximum of 5% losses to follow-up, a confidence of 5% and power of 90%, the total sample size is 60. This will allow detecting a difference in clinical outcome of 28%. Proportion will be compared by Chi square test.
Interim monitoring: Regular review of serious adverse events, quality and integrity of the study by an independent data safety and monitoring board. Safety interim analysis after 50% of the patients recruited.
Significance: Due to the high prevalence of CAP in children, this study will offer the potential for a substantial reduction in health costs and antibiotics resistance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Pneumonia, Children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BPS
Arm Type
Experimental
Arm Description
BPS guidance
Arm Title
Guideline
Arm Type
Active Comparator
Arm Description
Enforced guidelines
Intervention Type
Behavioral
Intervention Name(s)
Strategy based on BPS guided antibiotic use
Intervention Description
In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
Intervention Type
Behavioral
Intervention Name(s)
Enforced Guidelines
Intervention Description
In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
Primary Outcome Measure Information:
Title
Use of Antibiotics in Each Group
Description
The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Treatment Failure in Each Group
Description
Treatment failure was defined as: 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.
Proportion of patients with treatment failure was compared between both groups (BPS vs Guideline).
Time Frame
1, 2, 5, 7 and 10 days from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 3-60 months assisted as outpatients for non severe community acquired pneumonia.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando A Torres, MD
Organizational Affiliation
Hospital General de Niños Pedro de Elizalde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Niños Pedro de Elizalde
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1270AAN
Country
Argentina
12. IPD Sharing Statement
Citations:
PubMed Identifier
16493666
Citation
Moreno L, Krishnan JA, Duran P, Ferrero F. Development and validation of a clinical prediction rule to distinguish bacterial from viral pneumonia in children. Pediatr Pulmonol. 2006 Apr;41(4):331-7. doi: 10.1002/ppul.20364. Erratum In: Pediatr Pulmonol. 2006 May;41(5):494.
Results Reference
background
PubMed Identifier
19107303
Citation
Ferrero F, Torres F, Noguerol E, Gonzalez N, Lonegro L, Chiolo MJ, Ossorio MF, Benguigui Y. [Evaluation of two standardized methods for chest radiographs interpretation in children with pneumonia]. Arch Argent Pediatr. 2008 Dec;106(6):510-4. doi: 10.1590/S0325-00752008000600007. Spanish.
Results Reference
background
PubMed Identifier
24039234
Citation
Torres FA, Pasarelli I, Cutri A, Ossorio MF, Ferrero F. Impact assessment of a decision rule for using antibiotics in pneumonia: a randomized trial. Pediatr Pulmonol. 2014 Jul;49(7):701-6. doi: 10.1002/ppul.22849. Epub 2013 Aug 23.
Results Reference
result
Learn more about this trial
Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Community Acquired Pneumonia
We'll reach out to this number within 24 hrs