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Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia Clinical research trials and Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia. Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia clinical trial. Test subjects typically obtain the finest healthcare available for their Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia  Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia
Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia
For Condition: Pneumonia
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: This is a phase 3, multicenter, randomized, double-blind (third party unblinded) comparison of the efficacy and safety of tigecycline with those of levofloxacin in subjects initially hospitalized with community-acquired pneumonia (CAP). Subjects who have clinical signs and symptoms of CAP and who are hospitalized as a result will be considered for enrollment. Subjects will be randomly assigned (in a 1:1 ratio) to receive either tigecycline or levofloxacin via intravenous (IV) administration. Initially, subjects will be hospitalized and will receive IV test article for a minimum of 3 days (6 doses) and a maximum of 14 days (28 doses).
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 and female subjects 18 years of age. - Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated. - The presence of fever (within 24 hours prior to randomization), defined as oral temperature >38degreesC/100.4degreesF, axillary temperature >38.1degreesC/100.6degreesF, tympanic temperature >38.5degreesC/ 101.2degreesF, or a rectal/core temperature > 39degreesC/102.2degreesF OR hypothermia (within 24 hours prior to randomization), core temperature < 35degreesC/95degreesF. - Clinical criteria that include the presence of at least 2 of the following signs and symptoms: a. Cough; b. Production of purulent sputum or a change in the character of sputum consistent with bacterial infection; c. Auscultatory findings of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); d. Dyspnea or tachypnea, particularly if progressive in nature; e. Elevated total peripheral white blood cell count: WBC > 10 X 109/L (>10,000/mm3) OR > 15% immature neutrophils (bands) regardless of total peripheral WBC count OR Leukopenia with a total WBC count: WBC < 4.5 X 109/L (4500/mm3); f. Hypoxemia with a PO2 <60 mm Hg or oxygen saturation < 90% while subject is breathing room air; - Chest radiograph (posteroanterior and lateral) within 48 hours prior to the first dose of IV test article showing the presence of an infiltrate if previous films are not available, or a new infiltrate if previous films are available. - Subjects must not have received more than one dose of a non-study antibacterial agent to treat the current episode of CAP prior to the first dose of IV test article. If received, the prior non-study antibiotic must have been a drug with a dosing interval of less than once daily (e.g., every 12 hours, or every 8 hours). A single dose of once daily prior antibiotic is not allowed. Exception: Subjects who failed a previous course of therapy with another antibiotic for this episode of CAP (e.g., the pathogen is resistant to the prior antibiotic therapy, or clinical symptoms have not improved or have worsened after at least 2 full days of therapy) may be enrolled in the study. - The subject has voluntarily signed and dated the Institutional Review Board/Ethics Committee approved informed consent form prior to any study-specific screening procedures. If any subject is unable to give consent, it may be obtained from the subject’s legal representative in accordance with local laws and regulations. Exclusion Criteria: - 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 could be completed (e.g., life expectancy < 30 days). - Hospitalization within 14 days prior to the onset of symptoms. Exception: subjects hospitalized within the previous 24 hours for this episode of CAP may be enrolled. - Residence in a long-term care facility or nursing home 14 days before the onset of symptoms. - Fine Pneumonia Severity Index score of V or require treatment in an intensive care unit. - Concurrent hemodialysis, peritoneal dialysis, plasmapheresis, or hemoperfusion. - Presence of any clinically important central nervous system disease, including seizure disorders or conditions that may predispose the subject to seizures or lower the seizure threshold, or clinically important major psychiatric disorders that may interfere with compliance with the protocol. - Sustained shock at the time of randomization, defined as systolic blood pressure < 90 mm Hg for > 2 hours despite adequate fluid replacement, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure. - Risk factors for torsades de pointes, such as hypokalemia, significant bradycardia (as determined by the investigator), or cardiomyopathy. If the hypokalemia is corrected, patients may be enrolled. However, the potassium level should be monitored closely. - Known anatomical or pathological bronchial obstruction, or a history of bronchiectasis or post obstructive pneumonia. - Immunosuppressive therapy defined as chronic treatment with known immunosuppressive medications (including use of > 10 mg of prednisone or its equivalent per day over the 3-week period prior to randomization). - Receipt of an organ or bone marrow transplant. - Presence of any of the following: a. Known human immunodeficiency virus infection; b. Known or suspected Pseudomonas infection; c. Cystic fibrosis; d. Known or suspected Pneumocystis carinii pneumonia; e. Known Legionella pneumonia; f. Known or suspected active tuberculosis; g. Primary lung cancer; h. Any malignancy metastatic to the lungs; - Known or suspected hypersensitivity to tigecycline or other tetracyclines, levofloxacin or other quinolones, or any components of the levofloxacin product. - Failure to respond to levofloxacin (or other quinolone) therapy for the current episode of CAP. - Presence of any of the following laboratory findings: a. Neutropenia (absolute neutrophil count < 1 X 109/L [<1000/mm3]); b. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 10 times the upper limit of normal or total bilirubin > 3 times the upper limit of normal; c. Calculated creatinine clearance (CLCR) <20 mL/min; - Known or suspected concomitant bacterial infection requiring treatment with an additional systemic antibacterial agent. - Any investigational drugs taken or investigational devices used within 4 weeks before administration of the first dose of the IV test article. - Out-patient ventilator therapy within 14 days prior to the onset of symptoms, or ventilator therapy required at the time of screening. - Use of drugs known to prolong the QT interval, including class Ia and III antiarrhythmics. - Previous participation in this study. - 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 IV test article administration. - Any other major illness that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in this study.
Total Enrollment:
Location and Contact Information:
eStudy Site *Recruiting*
Chula Vista, California, 91910
United States
Recruiting William O'Riordan 619-470-4236
Doctor's Medical Center *Recruiting*
Modesto, California, 95350
United States
Recruiting Salah Bibi 209-527-4585
St. Francis Medical Center *Recruiting*
Trenton, New Jersey, 08629-1986
United States
Recruiting Jane Rohlf 609-599-6292
Odyssey Research Services *Recruiting*
Bismark, North Dakota, 58501
United States
Recruiting Anthony Tello 701-250-7355
St. Alexius Medical Center *Recruiting*
Bismark, North Dakota, 58501
United States
Recruiting Syad Zaidi 701-530-6950
Wichita Institute for Clinical Research *Recruiting*
Wichita, Kansas, 67214
United States
Recruiting Christine Faulk 316-636-9505
Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Kevin Chan 313-916-2433
University of Louisville *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting Julio Ramirez 502-852-7844
Genesis Hospitals *Recruiting*
Zanesville, Ohio, 43701
United States
Recruiting Larry Cowan 740-246-4242
Our Lady of Lourdes Regional Medial Center *Recruiting*
Lafayette, Louisiana, 70506
United States
Recruiting Roderick Clark 337-236-3039
Illinois Center for Clinical Trials *Recruiting*
Chicago, Illinois, 60610
United States
Recruiting Bangalore Murthy 312-988-4500
University of Texas Health Center - Tyler *Recruiting*
Tyler, Texas, 75708-3154
United States
Recruiting David Griffith 903-877-7267
Joseph M. Still Burn Center at Doctors Hospital *Recruiting*
Augusta, Georgia, 30909
United States
Recruiting Bruce Friedman 706-651-6669
Alachua General Hospital *Recruiting*
Gainesville, Florida, 32601
United States
Recruiting John Abernethy 352-331-8580
University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68918-5300
United States
Recruiting Austin Thompson 402-559-7585
Memorial Medical Center *Recruiting*
Springfield, Illinois, 62781
United States
Recruiting Donald Graham 217-527-4745
VA Medical Center *Recruiting*
Louisville, Kentucky, 40206
United States
Recruiting Julio Ramirez 502-852-1671
Palmetto Clinical Research *Recruiting*
Summerville, South Carolina, 29485
United States
Recruiting Colby Grossman 843-851-7098
Bay Pines VA Medical Center *Recruiting*
Bay Pines, Florida, 33744
United States
Recruiting C. Anderson 727-398-6661
Christiana Hospital *Recruiting*
Newark, New Jersey, 19718
United States
Recruiting John Reinhardt 302-623-0460
Forsyth Medical Center *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Peter Vrooman 336-659-1500
Grand View Hospital *Recruiting*
Sellersville, Pennsylvania, 18960
United States
Recruiting Albert Driver 215-253-8877
Springfield Clinic *Recruiting*
Springfield, Illinois, 62769
United States
Recruiting Donald Graham 217-527-4744
LSU Health Sciences Center *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Robert Penn 318-675-5925
St. Lukes Medical Center *Recruiting*
Phoenix, Arizona, 85006
United States
Recruiting Robert Kearl 602-253-6035
Additional Information:
Study ID Numbers: 3074A1-308-WW;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079885
Other Pneumonia Studies:
1. Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
2. A Safety and Efficacy Study of Hospitalized Patients with Community-Acquired Pneumonia and Sepsis
3. Venticute in Patients with Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
4. Ventilator-associated pneumonia / Hospital-acquired pneumonia requiring mechanical ventilatory support
5. Pediatric Community-Acquired Pneumonia
Related Studies:
Other Pneumonia Clinical Trials
Other Louisiana Clinical Trials
Other Lafayette Clinical Trials
Tigecycline versus Levofloxacin to Treat Subjects Hospitalized with Community-Acquired Pneumonia
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