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
NCT number | NCT00645619 |
Other study ID # | 022007-022 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | March 24, 2008 |
Est. completion date | March 26, 2008 |
Verified date | December 2018 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
United States | Childrens Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
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 |
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