|
Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) Clinical research trials and Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA). Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)  Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
For Condition: Bacteremia,Pneumonia, Bacterial,Skin Diseases, Bacterial
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Infectious Diseases Minneapolis, LTD *Recruiting*
Minneapolis, Minnesota, 55422
United States
Recruiting Christian Schrock 763-520-4342
St. Francis Medical Center *Recruiting*
Monroe, Louisiana,
United States
Recruiting Owen Meyers 318-327-4093
Legacy Emanuel Hospital and Medical Center *Recruiting*
Portland, Oregon, 97227
United States
Recruiting Dean Gubler 503-413-2100
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555
United States
Recruiting Glenn Hunter 409-772-2412
ClinSci International, Inc. *Recruiting*
Gainesville, Florida, 32605
United States
Recruiting John Abernethy 352-331-8580
Erie County Medical Center *Recruiting*
Buffalo, New York, 14215
United States
Recruiting William Flynn 716-898-5184
Hospital of the University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Emily Blumberg 215-662-7066
North Texas Infectious Disease Associates, P.A. *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Louis Sloan 214-823-2533
Our Lady of Lourdes Regional Medial Center *Recruiting*
Lafayette, Louisiana, 70506
United States
Recruiting Roderick Clark 337-236-3039
University Of Maryland School Of Medicine *Recruiting*
Baltimore, Maryland, 21202
United States
Recruiting Manjari Joshi 301-328-6056
Southwestern Medical Clinic *Recruiting*
Berrier Springs, Michigan, 49103
United States
Recruiting Mark Harrison 269-471-9679
Detar Hospital *Recruiting*
Victoria, Texas, 77901
United States
Recruiting T. Kasper 361-573-3895
University of Southern California/Norris Cancer Center *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Robert Beart 323-865-3894
Pepin Research Office, University Community Hospital *Recruiting*
Tampa, Florida, 33647
United States
Recruiting Jose Prieto 813-681-6474
Palmetto Clinical Research *Recruiting*
Summerville, South Carolina, 29485
United States
Recruiting Michael Otruba 843-851-7098
St. Vincent Mercy Medical Center *Recruiting*
Toledo, Ohio, 43608
United States
Recruiting Luis Jauregui 419-251-4919
Lousiana State University *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Robert Penn 318-675-5952
Erie County Medical Center *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Ali El-Solh 716-898-5685
University of Texas College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Luis Ostrosky 713-500-6732
Los Angeles County/USC Medical *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Michael Patzakis 323-226-7201
Wesley Medical Center *Recruiting*
Wichita, Kansas, 67214
United States
Recruiting Valerie Rohlman 316-688-3025
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting John Mazuski 314-362-1025
Bethesda Hospital *Recruiting*
Boynton Beach, Florida, 33435
United States
Recruiting Latha Srinath 561-735-7531
Upstate Infectious Diseases Associates *Recruiting*
Albany, New York, 12208
United States
Recruiting Ellis Tobin 518-436-0662
Springfield Clinic *Recruiting*
Springfield, Illinois, 62769
United States
Recruiting Donald Graham 217-527-4744
Christiana Care Healthcare Services *Recruiting*
Newark, New Jersey, 19718
United States
Recruiting John Reinhardt 302-623-0460
Internal Medicine and Infectious Diseases *Recruiting*
Modesto, California, 95350
United States
Recruiting Salah Bibi 209-527-4585
Jackson-Madison County General Hospital *Recruiting*
Jackson, Tennessee, 38301
United States
Recruiting Priscilla Sioson 731-425-6067
VA Medical Center *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Sanjay Revenkar 214-857-0409
St. Vincent Hospitals Health Services *Recruiting*
Indianapolis, Indiana, 46280
United States
Recruiting Markian Bochan 317-338-9337
Additional Information:
Study ID Numbers: 3074A1-307-WW;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079976
Other Pneumonia, Bacterial Studies:
1. Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
2. Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women with Chronic Infections
Related Studies:
Other Pneumonia, Bacterial Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
|
|
|
|
|
|
|
|
