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

Pneumonia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041209
• Other study ID #: HGNPE-186
• Status: Completed
• Phase: N/A
• First received: December 30, 2009
• Last updated: June 10, 2013
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2013
• Source: Hospital General de Niños Pedro de Elizalde
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 60 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Argentina	Hospital General de Niños Pedro de Elizalde	Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Niños Pedro de Elizalde

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Ferrero F, Torres F, Noguerol E, González 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. — View 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. Erratum in: Pediatr Pulmonol. 2006 May;41(5):494. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Antibiotics in Each Group	The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).	At baseline	No
Secondary	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).	1, 2, 5, 7 and 10 days from baseline	Yes