Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Community Acquired Pneumonia
NCT ID: NCT01041209
Last Updated: 2016-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2010-03-31
2012-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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BPS
BPS guidance
Strategy based on BPS guided antibiotic use
In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
Guideline
Enforced guidelines
Enforced Guidelines
In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
Interventions
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Strategy based on BPS guided antibiotic use
In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
Enforced Guidelines
In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe pneumonia
* Pulmonary or cardiovascular chronic disease
* Antibiotic use in the previous two weeks
* Hospitalization for any reason in the previous two weeks
3 Months
60 Months
ALL
No
Sponsors
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Hospital General de Niños Pedro de Elizalde
OTHER
Responsible Party
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Principal Investigators
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Fernando A Torres, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Niños Pedro de Elizalde
Locations
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Hospital General de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., Argentina
Countries
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References
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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.
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.
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.
Other Identifiers
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HGNPE-186
Identifier Type: -
Identifier Source: org_study_id