NCT01041209

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) 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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

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

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

September 27, 2012

Completed
Last Updated

December 28, 2016

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

December 30, 2009

Results QC Date

June 29, 2012

Last Update Submit

November 7, 2016

Conditions

Pneumonia

Keywords

PneumoniaChildren

Outcome Measures

Primary Outcomes (1)

  • Use of Antibiotics in Each Group

    The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).

    At baseline

Secondary Outcomes (1)

  • Treatment Failure in Each Group

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

Study Arms (2)

BPS

EXPERIMENTAL

BPS guidance

Behavioral: Strategy based on BPS guided antibiotic use

Guideline

ACTIVE COMPARATOR

Enforced guidelines

Behavioral: Enforced Guidelines

Interventions

Strategy based on BPS guided antibiotic useBEHAVIORAL

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
Enforced GuidelinesBEHAVIORAL

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

Eligibility Criteria

Age3 Months - 60 Months
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.

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 (3)

  • 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

  • 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.

    PMID: 24039234RESULT

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Fernando Torres
Organization
Hospital General de Niños Pedro de Elizalde
slaip@intramed.net
+54 11 43070140

Study Officials

  • Fernando A Torres, MD

    Hospital General 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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Study Start

March 1, 2010

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

December 28, 2016

Results First Posted

September 27, 2012

Record last verified: 2013-06

Locations

AR(1)