NCT01875731

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 4, 2015

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

June 10, 2013

Results QC Date

April 16, 2015

Last Update Submit

January 17, 2017

Conditions

Community Acquired Pneumonia

Keywords

PneumoniaAcute respiratory infectionDecision-support techniques

Outcome Measures

Primary Outcomes (1)

  • Use of Antibiotics in Each Group

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

    At day 7 from baseline

Secondary Outcomes (1)

  • Treatment Failure in Each Group

    1, 2, 5, 7 and 10 days from baseline

Study Arms (2)

BPS (Bacterial Pneumonia Score)

EXPERIMENTAL

Strategy based on BPS guided antibiotic use

Behavioral: BPS

Guideline

ACTIVE COMPARATOR

Strategy based on enforced guideline guided antibiotic use

Behavioral: Guideline

Interventions

BPSBEHAVIORAL

In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.

BPS (Bacterial Pneumonia Score)
GuidelineBEHAVIORAL

Strategy based on enforced guideline guided antibiotic use

Guideline

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Wheezing
  • Severe pneumonia
  • Pulmonary or cardiovascular chronic disease
  • Antibiotic use in the previous two weeks
  • Hospitalization for any reason in the previous two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de NIños Pedro de Elizalde

Buenos Aires, Buenos Aires F.D., C1270AAN, Argentina

Location

Related Publications (2)

  • 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.

    PMID: 16493666BACKGROUND

  • 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.

    PMID: 19107303BACKGROUND

MeSH Terms

Conditions

Community-Acquired PneumoniaPneumonia

Interventions

Guidelines as Topic

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesLung Diseases

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Dr. Fernando Torres
Organization
Hospital General de Niños Pedro de Elizalde
torresfernandoadrian@gmail.com
+54 11 43632100

Study Officials

  • Fernando A Torres, MD, PhD

    Hospital de Niños Pedro de Elizalde

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

July 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

March 3, 2017

Results First Posted

May 4, 2015

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)