Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine

• Sponsor: Hospital General de Niños Pedro de Elizalde (Other)
• Overall Status: Completed
• CT.gov ID: NCT01875731
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 5.5

Study Details

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) and pneumoccocal vaccine will reduce antibiotic use as compared to standard care practice (current guidelines for CAP).

Condition or Disease	Intervention/Treatment	Phase
Community Acquired Pneumonia	Behavioral: BPS; Behavioral: Guideline	N/A

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. 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 CAP)in 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 (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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BPS (Bacterial Pneumonia Score) Strategy based on BPS guided antibiotic use	Behavioral: BPS; In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
Active Comparator: Guideline Strategy based on enforced guideline guided antibiotic use	Behavioral: Guideline; Strategy based on enforced guideline guided antibiotic use

Outcome Measures

Primary Outcome Measures

1. Use of Antibiotics in Each Group [At day 7 from baseline]

   Number of participants with use of any antibiotic, at any time after diagnosis

Secondary Outcome Measures

1. Treatment Failure in Each Group [1, 2, 5, 7 and 10 days from baseline]

   Number of participants with 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children aged 3-60 months assisted as outpatients for non severe community acquired pneumonia and pneumoccocal vaccine and complete immunisation with pneumoccocal vaccine.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General de NIños Pedro de Elizalde	Buenos Aires	CF	Argentina	C1270AAN

Sponsors and Collaborators

• Hospital General de Niños Pedro de Elizalde

Investigators

• Principal Investigator: Fernando A Torres, MD, PhD, Hospital de Niños Pedro de Elizalde

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Hospital General de Niños Pedro de Elizalde
• ClinicalTrials.gov Identifier: NCT01875731
• Other Study ID Numbers: HGNPE 67-2012
• First Posted: Jun 12, 2013
• Last Update Posted: Mar 3, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hospital General de Niños Pedro de Elizalde: Pneumonia; Acute respiratory infection; Decision-support techniques
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Bacterial

Study Results

Participant Flow

Arm/Group Title	BPS (Bacterial Pneumonia Score)	Guideline
Arm/Group Description	Strategy based on BPS guided antibiotic use BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.	Strategy based on enforced guideline guided antibiotic use Guideline: Strategy based on enforced guideline guided antibiotic use
Period Title: Overall Study
STARTED	34	32
COMPLETED	33	32
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	BPS (Bacterial Pneumonia Score)	Guideline	Total
Arm/Group Description	Strategy based on BPS guided antibiotic use BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.	Strategy based on enforced guideline guided antibiotic use Guideline: Strategy based on enforced guideline guided antibiotic use	Total of all reporting groups
Overall Participants	33	32	65
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	17.2 (10.2)	17.5 (11)	17.5 (10.8)
Gender (Count of Participants)
Female	14 42.4%	18 56.3%	32 49.2%
Male	19 57.6%	14 43.8%	33 50.8%
Region of Enrollment (participants) [Number]
Argentina	33 100%	32 100%	65 100%

Outcome Measures

1. Primary Outcome

Title	Use of Antibiotics in Each Group
Description	Number of participants with use of any antibiotic, at any time after diagnosis
Time Frame	At day 7 from baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BPS (Bacterial Pneumonia Score)	Guideline
Arm/Group Description	Strategy based on BPS guided antibiotic use BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.	Strategy based on enforced guideline guided antibiotic use Guideline: Strategy based on enforced guideline guided antibiotic use
Measure Participants	33	32
Number [participants]	9 27.3%	21 65.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BPS (Bacterial Pneumonia Score), Guideline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.09
	Confidence Interval	(2-Sided) 95%; 1.57 to 16.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Treatment Failure in Each Group
Description	Number of participants with 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.
Time Frame	1, 2, 5, 7 and 10 days from baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BPS (Bacterial Pneumonia Score)	Guideline
Arm/Group Description	Strategy based on BPS guided antibiotic use BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.	Strategy based on enforced guideline guided antibiotic use Guideline: Strategy based on enforced guideline guided antibiotic use
Measure Participants	33	32
Number [participants]	3 9.1%	4 12.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BPS (Bacterial Pneumonia Score), Guideline
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.1 to 4.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	BPS (Bacterial Pneumonia Score)		Guideline
Arm/Group Description	Strategy based on BPS guided antibiotic use BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.		Strategy based on enforced guideline guided antibiotic use Guideline: Strategy based on enforced guideline guided antibiotic use
All Cause Mortality
	BPS (Bacterial Pneumonia Score)		Guideline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BPS (Bacterial Pneumonia Score)		Guideline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	BPS (Bacterial Pneumonia Score)		Guideline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.