A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.



Status:Completed
Conditions:Hospital, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:December 7, 2016
End Date:January 5, 2018

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Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936558 (Nivolumab) in Participants With Severe Sepsis or Septic Shock.

A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in
participants with severe sepsis or septic shock.


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Men and women ages ≥ 18 years old

- Documented or suspected infection

- Severe sepsis or septic shock for at least 24 hours

- Sepsis-induced immunosuppression

- In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours

Exclusion Criteria:

- Previous episode of severe sepsis or septic shock with ICU admission during the
current hospitalization

- Autoimmune disease

- Organ or bone marrow transplant

- Cancer treatment in the past 6 weeks

- Human immunodeficiency virus (HIV) infection and not on therapy prior to this episode
of sepsis; hepatitis C virus(HCV) infection and still has virus (not cured); Chronic
hepatitis B virus (HBV) infection and not on treatment

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
16
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
352
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Durham, NC
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
643
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Boston, MA
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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Sacramento, California 95814
2043
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Sacramento, CA
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Ann Arbor, Michigan 48109
Phone: 734-936-7469
165
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Ann Arbor, MI
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Atlanta, Georgia 30342
426
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Atlanta, GA
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Boston, Massachusetts 02215
643
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Boston, MA
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Colorado Springs, Colorado 80909
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Colorado Springs, CO
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
2
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Columbus, OH
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777 Bannock St
Denver, Colorado 80204
(303) 436-6000
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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Denver, CO
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
154
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Lexington, KY
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Peoria, Illinois 61637
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Peoria, IL
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Pittsburgh, Pennsylvania 15213
165
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Pittsburgh, PA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
2006
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Seattle, WA
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
563
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Springfield, MA
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