The clinical evaluation committee in a large multicenter phase 3 trial of drotrecogin alfa (activated) in patients with severe sepsis (PROWESS): Role, methodology, and results

Critical Care Medicine

Volumn 31, Issue 9, 2003, Pages 2291-2301

  Dhainaut, Jean François ^a   Laterre, Pierre François ^b   LaRosa, Steven P ^c   Levy, Howard ^c,d   Garber, Gary E ^e   Heiselman, Darell ^f   Kinasewitz, Gary T ^g   Light, R Bruce ^h   Morris, Peter ⁱ   Schein, Roland ^j   Sollet, Jean Pierre ^k   Bates, Becky M ^c   Utterback, Barbara G ^c   Maki, Dennis ^l  

^a Paris V University ^*  (France)

^b CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^c ELI LILLY AND COMPANY   (United States)

^d UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

^e UNIVERSITY OF OTTAWA   (Canada)

^f AKRON GENERAL MEDICAL CENTER   (United States)

^g UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

^h ST BONIFACE GENERAL HOSPITAL   (Canada)

ⁱ WAKE FOREST BAPTIST HEALTH   (United States)

^j JACKSON MEMORIAL HOSPITAL   (United States)

^k CENTRE HOSPITALIER VICTOR DUPOUY   (France)

^l University of Wisconsin Health   (United States)

more..

Author keywords

Activated protein C; Antibiotics; Clinical evaluation committee; Drotrecogin alfa (activated); Recombinant proteins; Sepsis; Septic shock; Severe sepsis; Xigris

Indexed keywords

ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT; DROTRECOGIN;

ANTIBIOTIC THERAPY; ARTICLE; BLOOD DISEASE; CARDIOVASCULAR INFECTION; CAUSE OF DEATH; CLINICAL EXAMINATION; CLINICAL TRIAL; COHORT ANALYSIS; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; EVALUATION; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; HUMAN; INFECTION RISK; LONG TERM CARE; MAJOR CLINICAL STUDY; MEDICAL PRACTICE; METABOLIC DISORDER; MULTICENTER STUDY; PATIENT COMPLIANCE; PHARMACODYNAMICS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RESPIRATORY TRACT INFECTION; SEPSIS; STATISTICAL SIGNIFICANCE; SURVIVAL; URINARY TRACT INFECTION;

ANTI-INFECTIVE AGENTS; APACHE; BACTEREMIA; CONFIDENCE INTERVALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; GRAM-NEGATIVE BACTERIAL INFECTIONS; GRAM-POSITIVE BACTERIAL INFECTIONS; HUMANS; INTENSIVE CARE UNITS; MALE; PROBABILITY; PROTEIN C; RECOMBINANT PROTEINS; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 0041639574     PISSN: 00903493     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.CCM.0000085089.88077.AF     Document Type: Article

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