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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bacterial Pneumonia; 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 Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Anticipated): March 24, 2008
• Primary Completion (Anticipated): March 26, 2008
• Study Completion (Actual): March 26, 2008

Study Registration Dates

• First Submitted: March 24, 2008
• First Submitted That Met QC Criteria: March 26, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pneumonia,viral; Pneumonia,bacterial; TREM-1 protein,human
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Viral; Pneumonia, Bacterial
• Other Study ID Numbers: 022007-022