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Observational Study of Sepsis and Pneumonia to Develop Diagnostic Tests

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National Center for Genome Resources.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
First received: November 23, 2005
Last updated: November 5, 2010
Last verified: January 2009
  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
Sepsis
Septicemia
Sepsis Syndrome
Shock, Septic
Community Acquired Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Protein Biomarker Based Diagnostics of Outcome in Sepsis & CAP

Resource links provided by NLM:


Further study details as provided by National Center for Genome Resources:

Primary Outcome Measures:
  • Death [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Septic Shock [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Severe Sepsis [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to death [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Death [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • Death [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Death [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Time to severe sepsis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Severe sepsis [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • Severe sepsis [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Severe sepsis [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Time to septic shock [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Septic Shock [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • Septic Shock [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Septic shock [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age]) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Time to Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age]) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age]) [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age]) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age]) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Hospitalization [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Days ] [ Designated as safety issue: No ]
  • ICU admission [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Length of ICU admission [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Disposition [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • Renal dysfunction [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Respiratory dysfunction [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Hematology dysfunction [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Metabolic dysfunction [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Renal SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Lung SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Coagulation SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Liver SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • CVS SOFA score [ Time Frame: 28 dadys ] [ Designated as safety issue: No ]
  • Time to respiratory SOFA Score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Time to coagulation SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Time to liver SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Time to CVS SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Time to Renal SOFA score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • DIC score >5 (modified ISTH scoring system) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Time to DIC score > 5 [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Development of ALI [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Development of ARDS [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Time to ALI [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Time to ARDS [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Ventilator [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Ventilator days [ Time Frame: Days ] [ Designated as safety issue: No ]
  • MELD score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Effect of early goal directed therapy on primary and secondary end-points [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Effect of Activated Protein C on primary and secondary end-points [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Effect of stress-dose corticosteroids on primary and secondary end-points [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Effect of intensive glycemic control on primary and secondary end-points [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • APACHE II score [ Time Frame: enrollment ] [ Designated as safety issue: No ]
  • APACHE II score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • PRISM III score [ Time Frame: enrollment ] [ Designated as safety issue: No ]
  • PRISM III score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • SOFA score [ Time Frame: enrollment ] [ Designated as safety issue: No ]
  • SOFA score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • CAP mortality [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • CAP and severe sepsis [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • CAP and septic shock [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Severe CAP (ATS criteria) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Severe CAP (BTS criteria) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Pneumococcal sepsis [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Staphylococcus aureus sepsis [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Gram negative rod sepsis [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Fungal sepsis [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • SeptiFast result [ Time Frame: Enrollment ] [ Designated as safety issue: No ]
  • SeptiFast result [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Microbiologic culture result [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Urinary legionella antigen [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Microbiologic culture [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • CAP, time to death [ Time Frame: days ] [ Designated as safety issue: No ]
  • CAP, mortality [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • CAP, mortality [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • CAP, mortality [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • CAP, time to severe sepsis [ Time Frame: Days ] [ Designated as safety issue: No ]
  • CAP, severe sepsis [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • CAP, severe sepsis [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • CAP, severe sepsis [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • CAP, time to septic shock [ Time Frame: days ] [ Designated as safety issue: No ]
  • CAP, septic shock [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • CAP, septic shock [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • CAP, septic shock [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Time to severe CAP (ATS and BTS criteria) [ Time Frame: Days ] [ Designated as safety issue: No ]
  • Severe CAP (ATS and BTS criteria) [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • Severe CAP (ATS and BTS criteria) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Severe CAP (ATS and BTS criteria) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • CAP, mechanical ventilation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • CAP, time to mechanical ventilation [ Time Frame: Days ] [ Designated as safety issue: No ]
  • CAP, length of mechanical ventilation [ Time Frame: Days ] [ Designated as safety issue: No ]
  • CAP, SOFA respiratory score > 2 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • CAP, respiratory component of severe sepsis criteria [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • CAP, hospitalized [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • CAP, length of hospitalization [ Time Frame: Days ] [ Designated as safety issue: No ]
  • CAP, ICU admission [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • CAP, length of ICU stay [ Time Frame: Days ] [ Designated as safety issue: No ]
  • CAP, Disposition [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • CAP, ALI [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • CAP, ARDS [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • CAP, time to ARDS [ Time Frame: days ] [ Designated as safety issue: No ]
  • CAP, time to ALI [ Time Frame: Days ] [ Designated as safety issue: No ]
  • CAP, PORT score [ Time Frame: enrollment ] [ Designated as safety issue: No ]
  • CAP, PORT score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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

  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
Study Population

Emergency department patients > 6 years of age

Criteria

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

  1. A core temperature of >= 38°C (100.4°F) or <= 36°C (96.8°F)
  2. 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
  3. 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
  4. 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 Criteria:

  1. Patient is less than 6 years of age.
  2. 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
  3. Human immunodeficiency virus (HIV) infection with a last known CD4 count of <50 mm3
  4. Acute presence of a cerebral vascular event, active gastrointestinal hemorrhage, seizure (acute episode), drug overdose, burn injury, trauma
  5. Patient is pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258869

Contacts
Contact: Stephen F Kingsmore, MB ChB BAO 505 995 4466 sfk@ncgr.org

Locations
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         
Sponsors and Collaborators
National Center for Genome Resources
Duke University
Henry Ford Hospital
Durham VA Medical Center
Pfizer
Hoffmann-La Roche
Investigators
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

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen F. Kingsmore, President, National Center for Genome Resources
ClinicalTrials.gov Identifier: NCT00258869     History of Changes
Other Study ID Numbers: 0001, U01 AI066569
Study First Received: November 23, 2005
Last Updated: November 5, 2010
Health Authority: United States: Federal Government

Keywords provided by National Center for Genome Resources:
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

Additional relevant MeSH terms:
Sepsis
Toxemia
Pneumonia
Shock, Septic
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Shock

ClinicalTrials.gov processed this record on November 20, 2014