Clinical Trial: Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

This study is currently recruiting patients.

Sponsored by: Wyeth
Information provided by: Wyeth

Purpose

A Phase 3, Multicenter, Double-Blind, Randomized (3:1) Study Evaluating Tigecycline And Linezolid For The Treatment Of Selected Serious Infections In Subjects With Vancomycin-Resistant Enterococcus And Evaluating Tigecycline And Vancomycin For The Treatment Of Selected Serious Infections In Subjects With Methicillin-Resistant Staphylococcus Aureus.

The primary objective of this study is to evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE or MRSA. The primary efficacy endpoint will be the clinical response for all subjects.

Condition Treatment or Intervention Phase
Bacteremia
Pneumonia, Bacterial
Skin Diseases, Bacterial
 Drug: Tigecycline
 Drug: Linezolid
 Drug: Vancomycin
Phase III

MedlinePlus related topics:  Bacterial Infections;   Pneumonia;   Sepsis;   Skin Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Safety/Efficacy Study

Official Title: A clinical research study to evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Male or female subjects aged 18 years or older.
  • Isolation of one of the following multi-antibiotic resistant bacteria: vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus faecalis, or methicillin-resistant Staphylococcus aureus, alone or as part of a polymicrobial infection.
  • Have a confirmed diagnosis of a serious infection (e.g., bacteremia [unless due to an excluded infection], complicated intra-abdominal infection, complicated skin and skin structure infection, or pneumonia) requiring administration of intravenous (IV) antibiotic therapy.
  • Specific criteria must also be met based on the subject’s baseline site of infection.
  • If a subject receives ≥ 72 hours of prior antibiotic therapy for the VRE or MRSA infection, they must have been declared a clinical failure, which is documented with positive culture(s) obtained after the last dose of the previous antibacterial therapy and within 1 calendar day prior to the first dose of test article.
  • Institutional review board (IRB)/independent ethics committee (IEC)-approved, signed, and dated informed consent form will be obtained from each subject before participation in this study. If any subject is unable to give consent, it may be obtained from the subject’s legal representative if this is in accordance with local laws and regulations.

Exclusion Criteria:

  • Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject’s participation in this study.
  • Anticipated length of antibiotic therapy less than 7 days.
  • For subjects with VRE, known or suspected hypersensitivity to tigecycline or linezolid, or other compounds related to these classes of antibacterial agents (e.g., oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA, known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds related to these classes of antibacterial agents (e.g., tetracyclines, minocycline, doxycycline).
  • Subjects with both MRSA and VRE identified as pathogens.
  • Subjects confirmed to have MRSA or VRE that in the investigator’s judgment is definitively proven to be colonization.
  • Subjects who received more than 3 doses of quinupristin/dalfopristin, 2 doses of vancomycin, or 2 doses of linezolid, for the VRE or MRSA infection, after the baseline culture was obtained but before the first dose of test article.
  • Infected diabetic foot ulcers or decubitis ulcers in which the infection is present for > 1 week’s duration.
  • Necrotizing fasciitis or gangrene, clinical suspicion of ecthyma gangrenosum, or crepitant cellulitis (gas gangrene).
  • Subjects suspected preoperatively to have a diagnosis of spontaneous bacterial peritonitis, simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, pancreatic abscess, or infected necrotizing pancreatitis.
  • Received any investigational drugs or devices (defined as lacking FDA, HPFB, or local regulatory agency approved indications) within 4 weeks before administration of the first dose of test article.
  • Subjects receiving immunosuppressive therapy that, in the opinion of the investigator, would decrease the subject’s ability to eradicate an infection, including use of high-dose corticosteroids (e.g., 40 mg or more of prednisone or equivalent per day).
  • Presence of hepatic disease: a) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >10 x the upper limit of normal (ULN). b) Bilirubin > 3 x ULN, unless isolated hyperbilirubinemia was directly related to the acute process. c) Acute hepatic failure or acute decompensation of chronic hepatic failure.
  • Neutropenia with absolute neutrophil count (ANC) < 500 mm3 unless MRSA or VRE is the only causative pathogen isolated at baseline.
  • Calculated creatinine clearance (ClCR) < 30 mL/min. Creatinine clearance may be calculated from the serum creatinine (SCR) concentration by the following equation: MALE: ClCR mL/min = (140-age) x weight (kg) / [72 x SCR (mg/dL)] FEMALE: ClCR mL/min = 0.85 x ClCR derived by above formula
  • Endocarditis or documented endovascular site of infection.
  • Urinary tract infection.
  • Osteomyelitis.
  • Meningitis.
  • Septic shock.
  • Septic arthritis.
  • Pregnant or breastfeeding women.
  • Female subjects of childbearing potential who do not agree to use a medically acceptable method of contraception throughout the duration of the study and for at least 1 month after the last dose of test article.
  • APACHE II score > 30.
  • Life expectancy estimated < 1 month.

Location and Contact Information


Alabama
      University of South Alabama, Mobile,  Alabama,  36617,  United States; Recruiting
Arnold Luterman, MD  251-471-7993 

California
      Los Angeles County/USC Medical, Los Angeles,  California,  90033,  United States; Recruiting
Michael Patzakis, MD  323-226-7201 

      Internal Medicine and Infectious Diseases, Modesto,  California,  95350,  United States; Recruiting
Salah Bibi, MD  209-527-4585 

      University of Southern California/Norris Cancer Center, Los Angeles,  California,  90033,  United States; Recruiting
Robert Beart, MD  323-865-3894 

      Southern Regional Medical Center, Riverdale,  California,  92868,  United States; Recruiting
Lee Diamond, MD  770-991-1500 

      Chest and Critical Care, Anaheim,  California,  92801,  United States; Recruiting
Harmohinder Gogia, MD  714-772-8282 

Colorado
      Denver Health Medical Center, Denver,  Colorado,  80204,  United States; Recruiting
Ernest Moore, MD  303-436-5643 

Florida
      Bethesda Hospital, Boynton Beach,  Florida,  33435,  United States; Recruiting
Laitha Srinath, MD  561-735-7531  Ext. 48 

      Pepin Research Office, University Community Hospital, Tampa,  Florida,  33647,  United States; Recruiting
Jose Prieto, MD  813-681-6474 

      ClinSci International, Inc., Gainesville,  Florida,  32605,  United States; Recruiting
John Abernethy, MD  352-331-8580 

Georgia
      Research Site, Atlanta,  Georgia,  30327,  United States; Recruiting
Arnold Lentnek, MD  770-429-0083 

      Baptist Medical Center South, Montgomery,  Georgia,  31604,  United States; Recruiting
Wickliffe Many, MD  334-265-2700 

Illinois
      St. John's Hospital, Springfield,  Illinois,  62769,  United States; Recruiting
Donald Graham, MD  217-527-4744 

      Evanston NW Healthcare Research Center, Evanston,  Illinois,  60201,  United States; Recruiting
Lance Peterson, MD  847-570-1637 

Indiana
      St. Vincent Hospitals Health Services, Indianapolis,  Indiana,  46280,  United States; Recruiting
Markian Bochan, MD  317-338-9337 

Kansas
      Wesley Medical Center, Wichita,  Kansas,  67214,  United States; Recruiting
Valerie Rohlman, MD  316-688-3025 

Louisiana
      Lousiana State University, Shreveport,  Louisiana,  71130,  United States; Recruiting
Robert Penn, MD  318-675-5952 

      St. Francis Medical Center, Monroe,  Louisiana,  71201,  United States; Recruiting
Owen Meyers, MD  318-327-4093 

Maryland
      University Of Maryland School Of Medicine, Baltimore,  Maryland,  21202,  United States; Recruiting
Manjari Joshi, MD  301-328-6056 

Michigan
      Southwestern Medical Clinic, Berrien Springs,  Michigan,  49103,  United States; Recruiting
Mark Harrison, MD  269-471-9679 

      Harper University Hospital, Detroit,  Michigan,  48201,  United States; Recruiting
Milagros Reyes, MD  313-745-9134 

      Sinai Grace Hospital, Detroit,  Michigan,  48235,  United States; Recruiting
Wasif Hafeez, MD  313-966-3250 

Minnesota
      Infectious Diseases Minneapolis, LTD, Minneapolis,  Minnesota,  55422,  United States; Recruiting
Christian Schrock, MD  763-520-4342 

Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States; Recruiting
John Mazuski, MD  314-362-5307 

      University of Missouri Hospital & Clinics, Columbia,  Missouri,  65212,  United States; Recruiting
William Salzer, MD  573-882-4759 

New Jersey
      Christiana Care Healthcare Services, Newark,  New Jersey,  19718,  United States; Recruiting
John Reinhardt, MD  302-733-4166 

      Cooper Hospital/University Medical Center, Camden,  New Jersey,  08103,  United States; Recruiting
Annette Reboli, MD  856-757-7767 

New York
      Erie County Medical Center, Buffalo,  New York,  14215,  United States; Recruiting
Ali El-Solh, MD  716-898-5283 

      Upstate Infectious Diseases Associates, Albany,  New York,  12208,  United States; Recruiting
Ellis Tobin, MD  518-436-0662 

      Erie County Medical Center, Buffalo,  New York,  14215,  United States; Recruiting
William Flynn, MD  716-898-5184 

      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
Paul Riska, M.D.  718-270-7588 

      Cabrini Medical Center, New York,  New York,  10003,  United States; Recruiting
Ari Klapholz, MD  212-995-7026 

      Erie County Medical Center, Buffalo,  New York,  14215,  United States; Recruiting
William Flynn, MD  716-898-5685 

Ohio
      St. Vincent Mercy Medical Center, Toledo,  Ohio,  43608,  United States; Recruiting
Luis Jauregi-Peredo, MD  419-251-4919 

      University Hospitals of Cleveland, Cleveland,  Ohio,  44106-4952,  United States; Recruiting
Robert Salata, MD  216-844-5386 

Oregon
      Legacy Emanuel Hospital and Medical Center, Portland,  Oregon,  97227,  United States; Recruiting
Dean Gubler, MD  503-413-2100 

Pennsylvania
      Hospital of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Emily Blumberg, MD  215-662-7066 

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting
Walter Biffl, MD  401-444-2892 

South Carolina
      Palmetto Clinical Research, Summerville,  South Carolina,  29485,  United States; Recruiting
Michael Otruba, MD  843-851-7098 

      Williams Jennings Byran Dorn V, Columbia,  South Carolina,  29209-1639,  United States; Recruiting
J. Brown, MD  803-776-4000  Ext. 7400 

Tennessee
      Jackson-Madison County General Hospital, Jackson,  Tennessee,  38301,  United States; Recruiting
Priscilla Sioson, MD  731-425-6472 

Texas
      VA Medical Center, Dallas,  Texas,  75216,  United States; Recruiting
Sanjay Revenkar, MD  214-857-0409 

      University of Texas College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Luis Ostrosky, MD  713-500-6732 

      Detar Hospital, Victoria,  Texas,  77901,  United States; Recruiting
T. Adam Kasper, MD  361-573-2111 

      Wilford Hall Medical Center, Lackland,  Texas,  78236,  United States; Recruiting
Alan Murdock  210-292-5594 

Virginia
      Sentara Leigh Hospital, Virginia Beach,  Virginia,  23462,  United States; Recruiting
David Blais, MD  757-668-5224 

More Information

Study ID Numbers:  3074A1-307-WW
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  March 19, 2004
ClinicalTrials.gov Identifier:  NCT00079976
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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