Use of TREM-1 Protein to Differentiate Viral and Bacterial Pneumonias in Intubated Children
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
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Viral Pneumonia Bacterial Pneumonia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Use of a Novel Protein (sTREM-1) to Differentiate Pure Viral Lung Infection From Viral With co-Existing Bacterial Lung Infection |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- TREM-1 level in the serum of all 4 groups [ Time Frame: Within 48 hours of intubation for TREM-1 level ] [ Designated as safety issue: No ]
- Length of ventilator support, length of ICU and hospital stay [ Time Frame: Within 48 hours of intubation for TREM-1 level ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Bronchoalveolar lavage fluid and Serum.
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1
Patients with pure viral pneumonia
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2
Patients with viral pneumonia along with secondary bacterial pneumonia
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3
Patients with significant bacterial pneumonia
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4
Patients with congenital heart disease undergoing cardiopulmonary bypass who have no pneumonia
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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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
- 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.
Contacts and Locations| Contact: Rangasamy K Anand, MBBS, MRCP | 214-456-2033 | rangasamy.anand@childrens.com |
| Contact: Amber Wood, RN | 214-456-6222 | amber.wood@childrens.com |
| United States, Texas | |
| Childrens Medical Center | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Study Director: | Robert Hardy, MD | University of Texas Southwestern Medical Center |
| Study Director: | Peter Luckett, MD | University of Texas Southwestern Medical Center |
More Information
No publications provided
| Responsible Party: | Rangasamy Anand MBBS, MRCP(UK), University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00645619 History of Changes |
| Other Study ID Numbers: | 022007-022 |
| Study First Received: | March 24, 2008 |
| Last Updated: | March 26, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
Pneumonia,viral Pneumonia,bacterial TREM-1 protein,human |
Additional relevant MeSH terms:
|
Pneumonia, Bacterial Pneumonia Pneumonia, Viral Bacterial Infections |
Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013