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

Bacterial Pneumonia Clinical Trial

Official title:

Use of a Novel Protein (sTREM-1) to Differentiate Pure Viral Lung Infection From Viral With Co-existing Bacterial Lung Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00645619
• Other study ID #: 022007-022
• Status: Withdrawn
• Start date: March 24, 2008
• Est. completion date: March 26, 2008

Study information

• Verified date: December 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 26, 2008
• Est. primary completion date: March 26, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Viral
• Viral Pneumonia

Locations

Country	Name	City	State
United States	Childrens Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	TREM-1 level in the serum of all 4 groups		Within 48 hours of intubation for TREM-1 level
Secondary	Length of ventilator support, length of ICU and hospital stay		Within 48 hours of intubation for TREM-1 level