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

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00645619

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

Brief 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 co-existing bacterial pneumonia than in children with pure viral pneumonia.

Condition or Disease	Intervention/Treatment	Phase
Viral Pneumonia Bacterial 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

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

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

Anticipated Study Start Date :

Mar 24, 2008

Anticipated Primary Completion Date :

Mar 26, 2008

Actual Study Completion Date :

Mar 26, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

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 [Within 48 hours of being intubated]

Secondary Outcome Measures

TREM-1 level in the BAL fluid of patients with pure bacterial pneumonia and no pneumonia [Within 48 hours of intubation for TREM-1 level]
TREM-1 level in the serum of all 4 groups [Within 48 hours of intubation for TREM-1 level]
Length of ventilator support, length of ICU and hospital stay [Within 48 hours of intubation for TREM-1 level]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Childrens Medical Center	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