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Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms Clinical research trials and Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms. Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms clinical trial. Test subjects typically receive the most effective healthcare possible for their Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms  Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms
Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms
For Condition: Gram-Negative Bacterial Infections,Bacteremia,Pneumonia
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: The primary objective of this study is to evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, e.g., Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, 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 a resistant gram-negative pathogen, e.g., Enterobacter species, Acinetobacter baumannii, Klebsiella pneumoniae, or other resistant gram-negative pathogens, alone or as 1 isolate 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 prior antibiotic therapy for the current infection, they must have been declared a clinical failure, which is documented with positive culture(s) obtained after the last dose of 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 < 7 days. - Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (e.g., tetracyclines, minocycline, doxycycline). - Subjects whose baseline resistant gram-negative organism is definitively proven to be colonization in the investigator’s judgment. - Subjects with infected diabetic foot ulcers or decubitis ulcers where the infection is present > 1 week’s duration. - Subjects with 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. - Subjects with known or suspected Pseudomonas aeruginosa. - 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) < 0.5 x 10^3/µL. - Endocarditis or documented endovascular site of infection. - Urinary tract infection. - Osteomyelitis. - Meningitis. - Septic shock. - Septic arthritis. - Known or suspected Legionella infection. - 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:
Christiana Care Healthcare Services *Recruiting*
Newark, Delaware, 19718
United States
Recruiting John Reinhardt 302-623-0460
St. Vincent Hospitals *Recruiting*
Indianapolis, Indiana, 46280
United States
Recruiting Markian Bochan 317-338-9337
Montefiore Medical Center *Recruiting*
Bronx, New York, 10467
United States
Recruiting Ira Leviton 718-920-5961
Bethesda Hospital *Recruiting*
Boynton Beach, Florida, 33435
United States
Recruiting Latha Srinath 561-735-7531
St. Francis Medical Center *Recruiting*
Monroe, Louisiana, 71210
United States
Recruiting Owen Meyers 318-327-4093
Our Lady of Lourdes Regional Medial Center *Recruiting*
Lafayette, Louisiana, 70506
United States
Recruiting Roderick Clark 337-236-3039
Jackson-Madison County General Hospital *Recruiting*
Jackson, Tennessee, 38301
United States
Recruiting Priscilla Sioson 731-425-6067
Erie County Medical Center *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Ali El-Solh 716-898-5685
Hospital of the University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Emily Blumberg 215-662-7066
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555
United States
Recruiting Glenn Hunter 409-772-2412
LSU Health Sciences Center *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Robert Penn 318-675-5925
Infectious Diseases Minneapolis, LTD *Recruiting*
Minneapolis, Minnesota, 55422
United States
Recruiting Christian Schrock 763-520-4342
Internal Medicine and Infectious Diseases *Recruiting*
Modesto, California, 95350
United States
Recruiting Salah Bibi 209-527-4585
VA Medical Center *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Sanjay Revankar 214-857-0409
North Texas Infectious Disease Associates, P.A. *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Louis Sloan 214-823-2533
Moanalua Medical Center *Recruiting*
Honolulu, Hawaii, 96819
United States
Recruiting Lawrence Eron 808-432-0000
University Community Hospital *Recruiting*
Tampa, Florida, 33647
United States
Recruiting Jose Prieto 813-681-6474
Springfield Clinic *Recruiting*
Springfield, Illinois, 62769
United States
Recruiting Donald Graham 217-527-4744
St. Michael's Medical Center *Recruiting*
Newark, New Jersey, 07102
United States
Recruiting Jihad Slim 973-877-2458
Wesley Medical Center *Recruiting*
Wichita, Kansas, 67214
United States
Recruiting Valerie Rohlman 316-688-3025
University Of Maryland School Of Medicine *Recruiting*
Baltimore, Maryland, 21202
United States
Recruiting Manjari Joshi 301-328-6056
St. Vincent Mercy Medical Ctr *Recruiting*
Toledo, Ohio, 43608
United States
Recruiting Luis Jauregui 419-251-4919
Detar Hospital *Recruiting*
Victoria, Texas, 77901
United States
Recruiting T. Kasper 361-573-3895
ClinSci International, Inc. *Recruiting*
Gainesville, Florida, 32605
United States
Recruiting John Abernethy 352-331-8580
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting John Mazuski 314-362-1025
Additional Information:
Study ID Numbers: 3074A1-309-WW;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079989
Other Gram-Negative Bacterial Infections Studies:
1. Antibiotic treatment for patients with infections of short term in-dwelling vascular catheters due to a specific bacteria (gram positive bacteria)
2. Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms
3. Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
4. Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
5. Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-related Bloodstream Infections
Related Studies:
Other Gram-Negative Bacterial Infections Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms
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