NCT02139384

Brief Summary

The purpose of the study is to create a clinical pneumonia tool that can be used to predict the cause of community-acquired pneumonia, which is a lung infection that began outside of the hospital in critically ill children therefore limiting unnecessary antibiotic use. The investigators will enroll critically ill children admitted with acute respiratory failure and suspected pneumonia. Each patient will receive a clinical pneumonia score blinded from culture and respiratory viral panel results. All care after samples obtained will be at the discretion of the PICU team. The investigators believe that our clinical pneumonia scale with procalcitonin will accurately designate viral from bacterial etiologies.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

May 8, 2014

Last Update Submit

April 24, 2017

Conditions

Keywords

procalcitonincommunity acquired pneumoniapneumonia score

Outcome Measures

Primary Outcomes (1)

  • Can our proposed pneumonia score distinguish community acquired bacterial pneumonia from community acquired viral pneumonia

    6 months

Eligibility Criteria

Age1 Day - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Study Population

critically ill children admitted the the LLU PICU with acute respiratory failure with suspected community-acquired pneumonia

You may qualify if:

  • All intubated pediatric patients
  • Age 1 day to 21 years
  • Admitted to the LLUCH PICU with suspected pneumonia for the next 6 months
  • Have received antibiotics for less than 12 hours
  • Have been intubated for less than 24 hours
  • Patients must be English or Spanish speaking for consent purposes.

You may not qualify if:

  • Patients who have received antibiotics for greater than 12 hours
  • Patients who have been intubated for greater than 24 hours
  • Patients who are unable to tolerate non-bronchoscopic bronchoalveolar lavage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Cynthia Tinsley, M.D.

    Loma Linda University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 15, 2014

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations