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Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects Clinical research trials and Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects. Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects clinical trial. Human subjects frequently get the finest healthcare available for their Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects  Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects
Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects
For Condition: Abdominal Abscess,Surgical Wound Infection
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: Primary Objective: To compare the efficacy and safety of tigecycline to that of imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects. Both the clinical response profile and the microbiological response profile will be assessed. The primary endpoint will be clinical response within the microbiological evaluable population at the test-of-cure assessment. Secondary Objectives: 1) To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause complicated intra-abdominal infections; 2) To evaluate microbiological efficacy; 3) To determine the pharmacokinetic profile in subjects with complicated intra-abdominal infections; 4) To compare health care utilization between treatment arms.
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: - Hospitalized male or female subjects, 18 years of age. - Subjects must be scheduled for or have had a laparotomy, laparoscopy or percutaneous drainage of an intra-abdominal abscess. - Subjects with a complicated intra-abdominal infection such as the following: a. an intra-abdominal abscess; b. an intra-abdominal abscess (including liver and spleen) that develops in a post-operative subject after receiving > 48 hours and 5 days of a nonstudy antibiotic. An intra-abdominal culture must be obtained from the infected site. c. appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess; d. perforated diverticulitis complicated by abscess formation or fecal contamination; e. complicated cholecystitis with evidence of perforation or empyema; f. perforation of the large or small intestine with abscess or fecal contamination;. g. purulent peritonitis or peritonitis associated with fecal contamination; h. gastric or duodenal ulcer perforation with symptoms lasting at least 24 hours prior to operation; i. traumatic bowel perforation with symptoms lasting at least 12 hours prior to operation. - The subject has not received more than 1 dose of an antibiotic (single broad spectrum agent or one dose of each antibiotic in a combination regimen such as metronidazole, ampicillin, gentamicin) AFTER the baseline intra-abdominal culture was obtained from the infected site. - Subjects may sign the informed consent preoperatively, however; test article should not be given unless there is a strong suspicion (elevated WBC, elevated band counts, or fever, or highly suggestive radiographic findings) or a confirmed diagnosis of an intra-abdominal infection (presence of pus within the abdominal cavity) and the baseline intra-abdominal culture is obtained or planned to be obtained from the infected site. - Institutional review board or Independent ethics committee approved, signed, and dated informed consent form. If any subject is unable to give consent, it may be obtained from the subject’s next of kin or legal representative if in accordance with local laws and regulations. Exclusion Criteria: - Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed. - Active or treated leukemia or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any metastatic malignancy to the abdomen with life expectancy less than 6 months. - Anticipated length of antibiotic therapy less than 5 days. - Presence of any uncontrolled central nervous system disease, including epilepsy or unexplained seizures. - Concomitant treatment with ganciclovir. - Known or suspected hypersensitivity to tigecycline, tetracycline agents, imipenem, cilastatin, or other compounds related to these classes of antibacterial agents. - The presence of hepatic disease: a. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), > 10 X upper limit of normal (ULN) values. b. Bilirubin > 3.0 x ULN, unless isolated hyperbilirubinemia was directly related to the acute process. c. Subjects with acute hepatic failure or acute decompensation of chronic hepatic failure. - Creatinine clearance < 41 mL/min/1.73m2 after adequate hydration. 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. BSA (m2) = (weight[kg])0.425 x (height [cm])0.725 x 0.007184 ClCR / BSA x 1.73 = mL/min/1.73m2 - Neutropenia with absolute neutrophil count (ANC) < 1000mm3 . Subjects with neutrophil counts as low as 500 cells/mm3 are permitted if the investigator feels the reduction is due to the acute infectious process. - Intra-abdominal infection known to be caused by one or more bacterial pathogens which are not susceptible to both of the test articles (eg., Pseudomonas aeruginosa, Proteus mirabilis, etc.) and which, in the investigator’s opinion, requires treatment with an additional antibacterial agent. - Received any investigational drugs (defined as lacking FDA, HPFB, or local regulatory agency approved indications) within 4 weeks before administration of the first dose of the test article (day 1). - Previous participation in this study. - Anticipation of leaving the fascia and/or deep muscular layers open or expectation of planned abdominal re-exploration either in or out of the operating room. - Pregnant women or nursing mothers. - Female subjects of childbearing potential who do not agree to practice sexual abstinence or use a medically acceptable method of contraception throughout the duration of the study and at least 1 month after the last dose of test article administration. - 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. - APACHE II score greater than 30. - Weight < 40 kg. - Immunosuppressive therapy that, in the opinion of the investigator, would decrease the subjects ability to eradicate the infection, including use of high-dose corticosteroids (e.g., 40 mg or more of prednisone or an equivalent per day) or known diagnosis of acquired immunodeficiency syndrome. - Subjects who receive intra-operative antibacterial irrigants or peritoneal antibacterial agents (e.g., irrigants, antibiotic impregnated sponges). - Presence of infection, requiring systemic antibiotic therapy, at a site other than the abdomen (e.g., urinary tract).
Total Enrollment:
Location and Contact Information:
University of Rochester Medical Center *Recruiting*
Rochester, New York, 14534
United States
Recruiting Rabih Solloum 585-275-7630
Complexe Hospitalier de la Sagamie *Recruiting*
Chicoutimi, Quebec, G7H 5H6
Canada
Recruiting Doria Grimard 418-541-1234
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Ronald Robertson 501-686-5230
SIU School of Medicine *Recruiting*
Springfield, Illinois, 62702
United States
Recruiting Nancy Khardori 217-782-0181
University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Ronald Squires 405-271-7912
Los Angeles County - USC Medical Center *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Albert Yellin 323-226-7737
VA Medical Center/Jackson Memorial *Recruiting*
Miami, Florida, 33125
United States
Recruiting Eduardo Parra-Davilla 305-324-3103
MMC Surgical Associates *Recruiting*
Portland, Maine, 04102
United States
Recruiting Gene Grindlinger 207-774-2381
Spartanburg Regional Medical Center *Recruiting*
Spartanburg, South Carolina, 29302
United States
Recruiting Charles Morrow 864-560-6812
St-Michael's Hospital *Recruiting*
Toronto, Ontario, M5B 1W8
Canada
Recruiting John Bohnen 416-864-5867
Hospital de Urgencia Asistencia Publica *Recruiting*
Santiago, ,
Chile
Recruiting Maria Campos 562-6342923
Hospital Roosevelt *Recruiting*
Guatemala City, ,
Guatemala
Recruiting Carlos Mejia 502-253-9438
Maricopa Medical Center *Recruiting*
Phoenix, Arizona, 85008
United States
Recruiting Mark Canulla 602-344-5751
Bay State Medical Center *Recruiting*
Springfield, Massachusetts, 01199
United States
Recruiting Patrick Lee 413-784-4030
New York Presbyterian Hospital *Recruiting*
New York City, New York, 10021
United States
Recruiting Philip Barie 212-746-5401
Medical College of VA, VA Commonwealth *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Ajai Malhotra 804-828-7748
Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033
United States
Recruiting James Ku 717-531-4488
Hospital Municipal Vereador Jose Storopoli *Recruiting*
Parque Novo Mundo, , 02181-160
Brazil
Recruiting Ricardo Kawamoto 55-11-6967-0103
University of Alberta Hospitals *Recruiting*
Edmonton, Alberta, T6G 2B7
Canada
Recruiting Stephen Shafran 780-407-6272
Northwestern University Medical Center *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Michael West 312-908-8686
Saint Vincent's Hospital *Recruiting*
Indianapolis, Indiana, 46260
United States
Recruiting Joseph Fraiz 317-587-2300
Medical College of Wisconsin *Recruiting*
Milwaukee, Wisconsin, 53221
United States
Recruiting John Weigelt 414-805-4626
Hospital Municpal Dr. Arthur Ribeiro de Saboya *Recruiting*
Sao Paulo, , 04330-020
Brazil
Recruiting Flavio Maciel 55-11-5011-5111
Toronto General Hospital *Recruiting*
Toronto, Ontario, M5G 2C4
Canada
Recruiting Ori Rotstein 416-340-3315
Hospital Civil de Guadeljara "Fray Antonio Alcalde" *Recruiting*
Guatelajara, ,
Mexico
Recruiting Eduardo Noriega 523336147645
Research Site *Recruiting*
Newport Beach, California, 92663
United States
Recruiting Charles Bailey 949-548-6811
Harbor-UCLA Medical Center *Recruiting*
Torrance, California, 90509
United States
Recruiting Stanley Klein 310-222-2795
LM Leonard Research Institute *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Terrance Kurtz 515-265-7301
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting John Mazuski 314-362-1176
Thomas Jefferson University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Timothy Babinchak 215-955-7785
The Ottawa General Campus *Recruiting*
Ottawa, Ontario, K1H 8L6
Canada
Recruiting Gary Garber 613-737-8184
University of Kentucky *Recruiting*
Lexington, Kentucky, 40536
United States
Recruiting Paul Kearney 606-323-6346
North Memorial Medical Center *Recruiting*
Minneapolis, Minnesota, 55422
United States
Recruiting Christian Schrock 763-520-4342
SUNY Downstate Medical Center *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting Paul Riska 732-557-8000
University of Texas Health Sciences Center *Recruiting*
Ft. Worth, Texas, 76107
United States
Recruiting German Berbel 817-735-5450
HOSCAR *Recruiting*
Santiago, ,
Chile
Recruiting Rebeca Areyuna 562-870-0024
Hospital Geral de *Recruiting*
Sao Paulo, , 06785-300
Brazil
Recruiting Claudia Zardo 55-11-4138-9437
Health Sciences Centre *Recruiting*
Winnipeg, Manitoba, R3A 1R9
Canada
Recruiting John Embil 204-787-2967
Royal Victoria Hospital *Recruiting*
Montreal, Quebec,
Canada
Recruiting Nicolas Christou 514-842-1231
Centre Hospitalier Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Germain Poirier 450-466-5000
Wishard Memorial Hospital *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Richard Kohler 317-274-7640
Saint Louis University Health Sciences Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Jeffrey Bailey 314-577-8802
Research Site *Recruiting*
Lansdale, Pennsylvania, 19446
United States
Recruiting Marc Alpert 215-368-2100
Northwest Medial Specialities *Recruiting*
Tacoma, Washington, 98405
United States
Recruiting David McEniry 253-528-8750
Hospital Beneficencia Portuguesa-Sao Paulo *Recruiting*
Paraiso, , 01323-010
Brazil
Recruiting Jacyr Paternak 55-11-3253-5022 ramal 1356
Hopital du Sacre-Coeur de Montreal *Recruiting*
Montreal, Quebec, H4J 1C5
Canada
Recruiting Jean-Francois Bellemare 514-338-2050
Hospital San Juan de Dios *Recruiting*
Guatemala City, ,
Guatemala
Recruiting Eduardo Arathoon 502-385-7609
University of California *Recruiting*
Orange, California, 92868
United States
Recruiting Samuel Wilson 714-456-7247
University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198
United States
Recruiting Mark Rupp 402-552-2755
Unidade de Enfermidades Infecciosas Hospital Espanol *Recruiting*
Rosario, ,
Argentina
Recruiting Joaquin Bernmejo 543414858700
Hospital Escuela Eva Peron *Recruiting*
Provincia de Santa Fe, ,
Argentina
Recruiting Osvaldo Teglia 54341-471-1881
Sanatorio Guemes *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Daniel Curcio 54 11 48648693
Seven Oaks General Hospital *Recruiting*
Winnipeg, Manitoba, R2V 3M3
Canada
Recruiting John Embil 204-787-4654
Department of Surgery Transplantation Services *Recruiting*
Washington D.C., District of Columbia, 20010-2975
United States
Recruiting John Kirkpatrick 808-532-2955
University of Texas Medical Center *Recruiting*
Galveston, Texas, 77555
United States
Recruiting Glenn Hunter 409-747-3014
C.U.S.M. Montreal Geneneral Hospital *Recruiting*
Montreal, Quebec, H3G 1A4
Canada
Recruiting David Evans 514-937-6011
Research Site *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Julia Garcia-Diaz 504-842-4005
ID Associates PA *Recruiting*
Hillsborough, New Jersey, 08844
United States
Recruiting Ronald Nahass 908-704-3755
Clinica Los Cedros de Tapiales *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Guillemo Benchetrit 5411-4622-8188
University of Hawaii School of Medicine *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting William Lau 808-532-2955
Medical Arts Clinic *Recruiting*
Corsicana, Texas, 75110
United States
Recruiting Robert Kingman 903-872-4611
Research Site *Recruiting*
Seattle, Washington, 98195
United States
Recruiting Patchen Dellinger 206-543-3682
Hospital geral de pedreira *Recruiting*
Sao Paulo, , 0455-170
Brazil
Recruiting Jose Orlando 55-11-5612-3000
Hospital Cayetano Heredia *Recruiting*
Urb. Ingenieria, ,
Peru
Recruiting Mario Castillo 5114820402
Additional Information:
Study ID Numbers: 3074A1-301-WW;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081744
Other Surgical Wound Infection Studies:
1. Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects
Related Studies:
Other Surgical Wound Infection Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Comparison Study of Tigecycline to Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects
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