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Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Community Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT01041209
Recruitment Status : Completed
First Posted : December 31, 2009
Results First Posted : September 27, 2012
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Pneumonia
Interventions Behavioral: Strategy based on BPS guided antibiotic use
Behavioral: Enforced Guidelines
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bacterial Pneumonia Score (BPS) Guideline
Hide Arm/Group Description Use of antibiotics according to Bacterial Pneumonia Score (BPS) guidance (antibiotic use when BPS > or = 4 points) Use of antibiotics according to local enforced guidelines
Period Title: Overall Study
Started 60 60
Completed 60 60
Not Completed 0 0
Arm/Group Title Bacterial Pneumonia Score (BPS) Guideline Total
Hide Arm/Group Description Bacterial Pneumonia Score (BPS) guidance Enforced guidelines Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
60
 100.0%
60
 100.0%
120
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
22.4  (13.2) 26.1  (13.2) 24.2  (14.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
33
  55.0%
30
  50.0%
63
  52.5%
Male
27
  45.0%
30
  50.0%
57
  47.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Argentina Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Use of Antibiotics in Each Group
Hide Description The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).
Time Frame At baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bacterial Pneumonia Score (BPS) Guideline
Hide Arm/Group Description:
Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
Indication of antibiotics according to local (Hospital) guidelines
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: participants
28 52
2.Secondary Outcome
Title Treatment Failure in Each Group
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bacterial Pneumonia Score (BPS) Guideline
Hide Arm/Group Description:
Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
Indication of antibiotics according to local (Hospital)guidelines.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: participants
5 5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bacterial Pneumonia Score (BPS) Guideline
Hide Arm/Group Description Bacterial Pneumonia Score (BPS) guidance Enforced guidelines
All-Cause Mortality
Bacterial Pneumonia Score (BPS) Guideline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bacterial Pneumonia Score (BPS) Guideline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bacterial Pneumonia Score (BPS) Guideline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Fernando Torres
Organization: Hospital General de Niños Pedro de Elizalde
Phone: +54 11 43070140
Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01041209     History of Changes
Other Study ID Numbers: HGNPE-186
First Submitted: December 30, 2009
First Posted: December 31, 2009
Results First Submitted: June 29, 2012
Results First Posted: September 27, 2012
Last Update Posted: December 28, 2016