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

NCT ID: NCT00645619

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-24

Study Completion Date

2008-03-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Viral Pneumonia Bacterial Pneumonia

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Patients with pure viral pneumonia

No interventions assigned to this group

2

Patients with viral pneumonia along with secondary bacterial pneumonia

No interventions assigned to this group

3

Patients with significant bacterial pneumonia

No interventions assigned to this group

4

Patients with congenital heart disease undergoing cardiopulmonary bypass who have no pneumonia

No interventions assigned to this group

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Hardy, MD

Role: STUDY_DIRECTOR

University of Texas Southwestern Medical Center

Peter Luckett, MD

Role: STUDY_DIRECTOR

University of Texas Southwestern Medical Center

Locations

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Childrens Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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022007-022

Identifier Type: -

Identifier Source: org_study_id