Status:
UNKNOWN
Observational Study of Sepsis and Pneumonia to Develop Diagnostic Tests
Lead Sponsor:
National Center for Genome Resources
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Duke University
Conditions:
Sepsis
Septicemia
Eligibility:
All Genders
6+ years
Brief Summary
We propose to develop novel diagnostic tests for severe sepsis and community acquired pneumonia (CAP). This program, entitled Community Acquired Pneumonia \& Sepsis Outcome Diagnostics (CAPSOD), is a ...
Detailed Description
3 interdependent aims are proposed to discover and initiate development of novel, in vitro diagnostic tests (IVD) for severe sepsis (SS) and community acquired pneumonia (CAP). Specific Aim 1: Discov...
Eligibility Criteria
Inclusion
- 1\. Patient has known or acute infection or suspected infection AND patient must meet at least 2 of the following 4 criteria to be enrolled
- A core temperature of \>= 38°C (100.4°F) or \<= 36°C (96.8°F)
- Patients \> 18 years of age, Heart rate of \>= 90 beats/min Patients 13-18 years of age, Heart rate of \>= 110 beats/min Patients 6-12 years of age, Heart rate of \>= 130 beats/min
- Patients \> 18 years of age, Respiratory rate of \>= 20 breaths/min Patients 13-18 years of age, Respiratory rate of \>= 14 breaths/min Patients 6-12 years of age, Respiratory rate of \>= 18 breaths/min OR PaCO2 of \<= 32 mm Hg OR Use of Mechanical Ventilation for an acute respiratory process
- Patients \> 18 years of age, White cell count \>= 12,000/mm3 or \<= 4,000/mm3 Patients 13-18 years of age, White cell count \>= 11,000/mm3 or \<= 4,500/mm3 Patients 6-12 years of age, White cell count \>= 13,500/mm3 or \<= 4,500/mm3 OR A differential count showing \> 10% immature neutrophils
Exclusion
- Patient is less than 6 years of age.
- Patient is not expected to survive 28 days because of uncorrectable medical condition (apart from pneumonia or sepsis), such as poorly controlled neoplasm or other end-stage disease, or patient has active DNR order
- Human immunodeficiency virus (HIV) infection with a last known CD4 count of \<50 mm3
- Acute presence of a cerebral vascular event, active gastrointestinal hemorrhage, seizure (acute episode), drug overdose, burn injury, trauma
- Patient is pregnant
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00258869
Start Date
December 1 2005
End Date
July 1 2010
Last Update
November 9 2010
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Durham VA Medical Center
Durham, North Carolina, United States, 27710