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

NCT00645619 | Withdrawn

• 1 other identifier: 022007-022
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Pneumonia; Bacterial Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Childrens Medical Center

Dallas, Texas, 75235, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bronchoalveolar lavage fluid and Serum.

MeSH Terms

Conditions

Pneumonia, Viral; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Robert Hardy, MD

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

• Peter Luckett, MD

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: March 24, 2008
• Primary Completion: March 26, 2008
• Study Completion: March 26, 2008
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

US (1)