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| Sponsors and Collaborators: |
National Center for Genome Resources National Institute of Allergy and Infectious Diseases (NIAID) Duke University Henry Ford Hospital Durham VA Medical Center Pfizer Hoffmann-La Roche |
|---|---|
| Information provided by: | National Center for Genome Resources |
| ClinicalTrials.gov Identifier: | NCT00258869 |
Purpose
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 multidisciplinary collaboration involving investigators at six organizations: NCGR; Duke University Medical Center, Durham, NC; Henry Ford Hospital, Detroit, MI; Eli Lilly and Company, Indianapolis, IN; Indiana Centers for Applied Protein Sciences, Indianapolis, IN; and ProSanos Corp., La Jolla, CA.
In the United States, Community Acquired Pneumonia is the sixth leading cause of death and the number one cause of death from infectious diseases. Of the 5.6 million annual cases of CAP, 1.1 million require hospitalization for intensive therapy. Sepsis, commonly known as blood poisoning or bloodstream infection, is the tenth leading cause of death in the US and the number one cause of death in non-cardiac intensive care units. Incidence of sepsis is increasing by 9% each year and mortality rates vary between 25 and 50%. Cost to the US healthcare system exceeds $20 billion each year.
In patients with suspected sepsis or early CAP, rapid identification of patients who will develop severe sepsis or CAP is critical for effective management and positive outcome. The CAPSOD study is designed to identify novel tests for early diagnosis of severe sepsis and CAP. When performed in patients at the earliest stages of disease, these tests will have prognostic value, rapidly identifying those who will have poor outcomes or complicated courses.
CAPSOD will prospectively enroll patients with sepsis and CAP at Duke University Medical Center and Henry Ford Hospital. The study will use advanced bioinformatic, metabolomic, proteomic and mRNA sequencing technologies to identify specific protein changes, or biomarkers, in patient blood samples that predict outcome in sepsis and CAP. Development of biomarker-based tests will permit patient selection for appropriate disposition, such as the intensive care unit, and use of intensive medical therapies, thereby reducing mortality and increasing effectiveness of resource allocation.
| Condition |
|---|
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Sepsis Septicemia Sepsis Syndrome Shock, Septic Community Acquired Pneumonia |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Plasma Protein Biomarker Based Diagnostics of Outcome in Sepsis & CAP |
PaxGene whole blood tubes (RNA and DNA), EDTA plasma, serum (subset), microbiologic isolates
| Estimated Enrollment: | 1200 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Emergency department patients with sepsis
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Show Detailed Description Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Emergency department patients > 6 years of age
Inclusion Criteria:
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
Exclusion Criteria:
Contacts and Locations| Contact: Stephen F Kingsmore, MB ChB BAO | 505 995 4466 | sfk@ncgr.org |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Emanuel P Rivers, MD 800-436-7936 erivers1@hfhs.org | |
| Principal Investigator: Emanuel P Rivers, MD | |
| Principal Investigator: Ronny Otero, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Vance G Fowler, MD 919-668-2549 Fowle003@mc.duke.edu | |
| Principal Investigator: Vance G Fowler, MD | |
| Principal Investigator: Christopher W Woods, MD | |
| Durham VA Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Christopher Woods, MD 919-451-9795 woods004@mc.duke.edu | |
| Principal Investigator: Christopher Woods, MD | |
| Principal Investigator: | Stephen F Kingsmore, MB ChB BAO | National Center for Genome Resources |
| Study Director: | Vance Jr G Fowler, MD | Duke University |
| Study Director: | Emanuel P Rivers, MD | Henry Ford Hospital |
| Study Director: | Christopher W Woods, MD | Duke University |
| Study Director: | Ralph G Corey, MD | Duke University |
| Study Director: | Ronny Otero, MD | Henry Ford Hospital |
| Study Director: | Brian W Grinnell, PhD | Eli Lilly and Company |
| Study Director: | Brian T Edmonds, PhD | Eli Lilly and Company |
| Study Director: | Mu Wang, PhD | INCAPS |
| Study Director: | James R Ludwig, PhD | INCAPS |
More Information
| Responsible Party: | National Center for Genome Resources ( Stephen F. Kingsmore, President ) |
| Study ID Numbers: | 0001, U01 AI066569 |
| Study First Received: | November 23, 2005 |
| Last Updated: | January 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00258869 |
| Health Authority: | United States: Federal Government |
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prospective studies biological assay body weights and measures chemistry, analytical microchip analytical procedures spectrum analysis, mass molecular diagnostic techniques microbiological techniques drug administration schedule data collection statistics gene expression profiling sequence analysis human experimentation immunoassay |
Trauma severity indices Glasgow Coma score Outcome assessment mortality computer models decision modeling linear models logistic models immunologic model mathematical model non-linear models early diagnosis diagnosis, computer assisted medical informatics prognosis |
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Systemic Inflammatory Response Syndrome Body Weight Coma Sepsis Respiratory Tract Infections Respiratory Tract Diseases |
Shock Lung Diseases Shock, Septic Wounds and Injuries Pneumonia Inflammation |
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Disease Pathologic Processes Syndrome Infection |
