Community Acquired PneumoniaNCT02139384
Clinical Pediatric Pneumonia Score in Critically Ill Children
An observational study of Community Acquired Pneumonia, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Community Acquired Pneumonia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: critically ill children admitted the the LLU PICU with acute respiratory failure with suspected community-acquired pneumonia
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Children's Hospital
Loma Linda, California, 92354
About this study
Official title: 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.
- Conditions
- Community Acquired Pneumonia
- Keywords
- procalcitonin, community acquired pneumonia, pneumonia score
- Medical subject headings
- Community-Acquired Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Can our proposed pneumonia score distinguish community acquired bacterial pneumonia from community acquired viral pneumonia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: The study was withdrawn due to inability to enroll patients in a timely fashion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Tinsley, M.D., Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139384
- Sponsor's protocol ID
- 5110327
- Status last verified
- Apr 2017
- First submitted
- 8 May 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Clinical Pediatric Pneumonia Score in Critically Ill Children Admitted With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT02139384
- Acronym / sponsor ID
- 5110327
- Conditions
- Community Acquired Pneumonia
- Keywords
- procalcitonin, community acquired pneumonia, pneumonia score
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to inability to enroll patients in a timely fashion.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- critically ill children admitted the the LLU PICU with acute respiratory failure with suspected community-acquired pneumonia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Can our proposed pneumonia score distinguish community acquired bacterial pneumonia from community acquired viral pneumonia
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Tinsley, M.D. principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can our proposed pneumonia score distinguish community acquired bacterial pneumonia from community acquired viral pneumonia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.