Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01875731
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2013-06-10
Brief Title:
Bacterial Pneumonia Score BPS Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine
Sponsor:
Hospital General de Niños Pedro de Elizalde
Organization:
Hospital General de Niños Pedro de Elizalde
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 and pneumoccocal vaccine 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 childrens risk of bacterial pneumonia Recently we assessed BPS efficacy on reducing antibiotic use by 50 in children with CAP in an ambulatory setting However BPS was tested in children not vaccinated against S pneumoniae
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 CAPin children vaccinated against S penumoniae
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 and pneumoccocal vaccine 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 11 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
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 CAPin children vaccinated against S penumoniae
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 and pneumoccocal vaccine 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None