- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02139384
Clinical Pediatric Pneumonia Score in Critically Ill Children
April 24, 2017 updated by: Loma Linda University
Development of a Clinical Pediatric Pneumonia Score in Critically Ill Children Admitted With Acute Respiratory Failure
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Study Population
critically ill children admitted the the LLU PICU with acute respiratory failure with suspected community-acquired pneumonia
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Can our proposed pneumonia score distinguish community acquired bacterial pneumonia from community acquired viral pneumonia
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia Tinsley, M.D., Loma Linda University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
May 8, 2014
First Submitted That Met QC Criteria
May 12, 2014
First Posted (Estimate)
May 15, 2014
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5110327
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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