Use of TREM-1 Protein to Differentiate Viral and Bacterial Pneumonias in Intubated Children - Full Text View

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00645619

Purpose

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.

Condition
Viral Pneumonia Bacterial Pneumonia

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Use of a Novel Protein (sTREM-1) to Differentiate Pure Viral Lung Infection From Viral With co-Existing Bacterial Lung Infection

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
TREM-1 level in the serum of all 4 groups [ Time Frame: Within 48 hours of intubation for TREM-1 level ] [ Designated as safety issue: No ]
Length of ventilator support, length of ICU and hospital stay [ Time Frame: Within 48 hours of intubation for TREM-1 level ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Bronchoalveolar lavage fluid and Serum.

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

Children from birth to 18 years intubated for respiratory failure or for surgery as mentioned above within 48 hours of intubation.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645619

Contacts

Contact: Rangasamy K Anand, MBBS, MRCP	214-456-2033	rangasamy.anand@childrens.com
Contact: Amber Wood, RN	214-456-6222	amber.wood@childrens.com

Locations

United States, Texas
Childrens Medical Center	Recruiting
Dallas, Texas, United States, 75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Study Director:	Robert Hardy, MD	University of Texas Southwestern Medical Center
Study Director:	Peter Luckett, MD	University of Texas Southwestern Medical Center

More Information

No publications provided

Responsible Party:	University of Texas Southwestern Medical Center ( Rangasamy Anand MBBS, MRCP(UK) )
Study ID Numbers:	022007-022
Study First Received:	March 24, 2008
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00645619 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Pneumonia,viral
Pneumonia,bacterial
TREM-1 protein,human

Study placed in the following topic categories:

Virus Diseases
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Pneumonia, Viral
Pneumonia, Bacterial
Pneumonia

Additional relevant MeSH terms:

Virus Diseases
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Pneumonia, Viral
Pneumonia, Bacterial
Pneumonia

ClinicalTrials.gov processed this record on September 10, 2009