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WithdrawnNCT00645619Updated Dec 26, 2018

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

An observational study in Viral Pneumonia and Bacterial Pneumonia, sponsored by University of Texas Southwestern Medical Center. Withdrawn at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-12-26.

Sponsored by University of Texas Southwestern Medical Center · Observational

Why this study was withdrawn
PI is no longer with the University
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
0
Ages
Up to 18 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Viral Pneumonia
  • Bacterial Pneumonia

Keywords

  • Pneumonia,viral
  • Pneumonia,bacterial
  • TREM-1 protein,human
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

Browse Pneumonia studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Biospecimen retention
Samples without dna

Groups and 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

06

What researchers measure

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

    Time frame: Within 48 hours of being intubated

Secondary outcomes

  1. 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

  2. TREM-1 level in the serum of all 4 groups

    Time frame: Within 48 hours of intubation for TREM-1 level

  3. Length of ventilator support, length of ICU and hospital stay

    Time frame: Within 48 hours of intubation for TREM-1 level

07

Study locations

1 site
  • Childrens Medical Center
    Dallas, Texas 75235, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00645619
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Sponsor
First posted
Mar 27, 2008
Start date
Mar 24, 2008 (estimated)
Primary completion
Mar 26, 2008 (estimated)
Completion
Mar 26, 2008
Last update
Dec 26, 2018

Study contacts

Robert Hardy, MD
study director · University of Texas Southwestern Medical Center
Peter Luckett, MD
study director · University of Texas Southwestern Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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