Viral PneumoniaNCT00645619
Use of TREM-1 Protein to Differentiate Viral and Bacterial Pneumonias in Intubated Children
An observational study of Viral Pneumonia and Bacterial Pneumonia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a protein called TREM-1 can be used to differentiate viral and bacterial pneumonias in children who are on ventilator support. We propose that the level of TREM-1 will be significantly elevated in the lung fluid of children with bacterial pneumonia and viral with… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Viral Pneumonia, Bacterial Pneumonia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2008to 26 Mar 2008
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Intubated patients in the intensive care unit with respiratory failure. Intubated patients patients in the OR undergoing video-assisted thoracic surgery for empyema. Intubated patients undergoing cardiopulmonary bypass.
Who may be able to join
- Children from birth to 18 years intubated for respiratory failure or for surgery as mentioned above within 48 hours of intubation.
Who cannot join
- Use of antibiotics >72 hours preceding the study (not applicable to the definite bacterial pneumonia group)
- Use of oral/parenteral glucocorticoid therapy <2 weeks prior to admission
- Presence of tracheostomy
- Active treatment for pulmonary arterial hypertension
- Mechanical ventilation with FIO2 >0.6, MAP>20
- Presence of severe pulmonary interstitial emphysema, pneumothorax, bradycardia (heart rate, <80 beats/min in neonates, <70 beats/min in infants), hypotension (mean arterial pressure, <40 mm Hg in neonates, <50 mm Hg in infants), and platelet count of <30,000/mm3.
- Immunodeficient or immunocompromised due to other conditions.
- Enrollment in another interventional study that employs BAL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Novel Protein (sTREM-1) to Differentiate Pure Viral Lung Infection From Viral With Co-existing Bacterial Lung Infection
The purpose of this study is to determine whether a protein called TREM-1 can be used to differentiate viral and bacterial pneumonias in children who are on ventilator support. We propose that the level of TREM-1 will be significantly elevated in the lung fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.
Read the detailed description
Most often, viruses are the cause of pneumonia in children. However, viral pneumonias are frequently associated with secondary bacterial pneumonia. It is important, though difficult, to differentiate patients who only have viral pneumonia from those who have viral pneumonia with secondary bacterial pneumonia. This will help physicians to prescribe antibiotics to only those with bacterial pneumonia and avoid antibiotic use in those with pure viral pneumonia, thus help to limit health-care cost and to decrease emergence of antibiotic resistance. In adult studies, TREM-1 has been shown to be specifically expressed in bacterial infections.
We propose that measuring TREM-1 in the bronchoalveolar lavage (BAL) fluid will help to differentiate these groups. Our hypothesis is that concentration of TREM-1 will be significantly elevated in the BAL fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.
- Conditions
- Viral Pneumonia, Bacterial Pneumonia
- Keywords
- Pneumonia,viral, Pneumonia,bacterial, TREM-1 protein,human
- Medical subject headings
- Pneumonia, Viral, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with pure viral pneumonia | |
| 2 | Patients with viral pneumonia along with secondary bacterial pneumonia | |
| 3 | Patients with significant bacterial pneumonia | |
| 4 | Patients with congenital heart disease undergoing cardiopulmonary bypass who have no pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
TREM-1 level in the BAL fluid of patients with pure viral pneumonia in comparison to patients with viral with co-existing bacterial pneumonia
Measured: Within 48 hours of being intubated
Secondary outcomes (3)
TREM-1 level in the BAL fluid of patients with pure bacterial pneumonia and no pneumonia
Measured: Within 48 hours of intubation for TREM-1 level
TREM-1 level in the serum of all 4 groups
Measured: Within 48 hours of intubation for TREM-1 level
Length of ventilator support, length of ICU and hospital stay
Measured: Within 48 hours of intubation for TREM-1 level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study start24 Mar 2008 (estimated)
- Primary completion26 Mar 2008 (estimated)
- Study completion26 Mar 2008
Why it stopped: PI is no longer with the University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral PneumoniaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Hardy, MD, Study director, University of Texas Southwestern Medical CenterPeter Luckett, MD, Study director, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645619
- Sponsor's protocol ID
- 022007-022
- Status last verified
- Dec 2018
- First submitted
- 24 Mar 2008
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Protein (sTREM-1) to Differentiate Pure Viral Lung Infection From Viral With Co-existing Bacterial Lung Infection
- ClinicalTrials.gov ID
- NCT00645619
- Acronym / sponsor ID
- 022007-022
- Conditions
- Viral Pneumonia, Bacterial Pneumonia
- Keywords
- Pneumonia,viral, Pneumonia,bacterial, TREM-1 protein,human
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI is no longer with the University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 24 Mar 2008 (estimated)
- Primary completion
- 26 Mar 2008 (estimated)
- Study completion
- 26 Mar 2008 (actual)
- First posted
- 27 Mar 2008 (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 this study is to determine whether a protein called TREM-1 can be used to differentiate viral and bacterial pneumonias in children who are on ventilator support. We propose that the level of TREM-1 will be significantly elevated in the lung fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.
Detailed description
Most often, viruses are the cause of pneumonia in children. However, viral pneumonias are frequently associated with secondary bacterial pneumonia. It is important, though difficult, to differentiate patients who only have viral pneumonia from those who have viral pneumonia with secondary bacterial pneumonia. This will help physicians to prescribe antibiotics to only those with bacterial pneumonia and avoid antibiotic use in those with pure viral pneumonia, thus help to limit health-care cost and to decrease emergence of antibiotic resistance. In adult studies, TREM-1 has been shown to be specifically expressed in bacterial infections.
We propose that measuring TREM-1 in the bronchoalveolar lavage (BAL) fluid will help to differentiate these groups. Our hypothesis is that concentration of TREM-1 will be significantly elevated in the BAL fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with pure viral pneumonia |
| 2 | – | –Patients with viral pneumonia along with secondary bacterial pneumonia |
| 3 | – | –Patients with significant bacterial pneumonia |
| 4 | – | –Patients with congenital heart disease undergoing cardiopulmonary bypass who have no pneumonia |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Intubated patients in the intensive care unit with respiratory failure. Intubated patients patients in the OR undergoing video-assisted thoracic surgery for empyema. Intubated patients undergoing cardiopulmonary bypass.
Key inclusion criteria (1 listed)
- Children from birth to 18 years intubated for respiratory failure or for surgery as mentioned above within 48 hours of intubation.
Key exclusion criteria (8 listed)
- Use of antibiotics >72 hours preceding the study (not applicable to the definite bacterial pneumonia group)
- Use of oral/parenteral glucocorticoid therapy <2 weeks prior to admission
- Presence of tracheostomy
- Active treatment for pulmonary arterial hypertension
- Mechanical ventilation with FIO2 >0.6, MAP>20
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
TREM-1 level in the BAL fluid of patients with pure viral pneumonia in comparison to patients with viral with co-existing bacterial pneumonia
Time frame: Within 48 hours of being intubated
3 secondary outcomes
TREM-1 level in the BAL fluid of patients with pure bacterial pneumonia and no pneumonia
Time frame: Within 48 hours of intubation for TREM-1 level
TREM-1 level in the serum of all 4 groups
Time frame: Within 48 hours of intubation for TREM-1 level
Length of ventilator support, length of ICU and hospital stay
Time frame: Within 48 hours of intubation for TREM-1 level
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 26 Dec 2018.
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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.
Robert Hardy, MD study director
University of Texas Southwestern Medical Center
Peter Luckett, MD study director
University of Texas Southwestern Medical Center
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 Viral Pneumonia and Bacterial Pneumonia, run by University of Texas Southwestern Medical Center 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 1 inclusion and 8 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 26 Dec 2018. 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?
TREM-1 level in the BAL fluid of patients with pure viral pneumonia in comparison to patients with viral with co-existing bacterial pneumonia (time frame: Within 48 hours of being intubated). 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 26 Dec 2018.