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Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia Clinical research trials and Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia. Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia clinical trial. Human subjects often obtain the finest healthcare possible for their Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia  Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
Intravenous Tigecycline Versus Intravenous 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 IV tigecycline with those of IV levofloxacin in subjects hospitalized with 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 IV administration. Subjects will be hospitalized and will receive IV test article for a minimum of 7 days (14 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 and in Bulgaria only < 70 years of age. - Subjects hospitalized with CAP with a severity that requires IV antibiotic treatment for at least 7 days. - The presence of fever (within 24 hours before randomization), defined as oral temperature >38degC/100.4degF, axillary temperature >38.1degC/ 100.6degF, tympanic temperature >38.5degC/ 101.2degF, or a rectal/core temperature 39debC/102.2degF OR Hypothermia (within 24 hours before randomization), core temperature <35degC/95degF. - 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 10^9/L (>10,000/mm^3) OR >15% immature neutrophils (bands) regardless of total peripheral WBC count OR Leukopenia with a total WBC count <4.5 x 10^9/L (4500/mm^3); f. Hypoxemia with a PO2 < 60 mm Hg or oxygen saturation < 90% while subject is breathing room air; - Chest radiograph (posteroanterior and lateral, if possible) within 48 hours before the first dose of IV test article showing the presence of a new infiltrate. - Subjects must not have received more than one dose of a nonstudy antibacterial agent to treat the current episode of CAP before 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 to respond to a previous course of outpatient therapy with oral antibiotics for this episode of CAP (ie clinical symptoms have worsened after at least 2 full days of therapy) may be enrolled in the study. The decision and reasons for the switch are to be recorded in the source document and case report form (CRF). - The subject has voluntarily signed and dated the Institutional Review Board/Ethics Committee-approved informed consent form before 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 (eg, life expectancy < 30 days). - Hospitalization within 14 days before the onset of symptoms. - Residence in a long-term care facility or nursing home 14 days before the onset of symptoms. - Treatment in an intensive care unit required. - Concurrent hemodialysis, hemofiltration, peritoneal dialysis or plasmapheresis. - 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: a) systolic blood pressure < 90 mm Hg for >2 hours despite adequate fluid replacement, with evidence of hypoperfusion or, b) need for sympathomimetic agents to maintain blood pressure. Note: the use of sympathomimetic agents to maintain adequate renal perfusion is allowed. - Risk factors for torsades de pointes, such as hypokalemia, significant bradycardia (as determined by the investigator), or cardiomyopathy. If the hypokalemia is corrected, subject may be enrolled; however, the potassium level should be monitored closely. - A deficiency in glucose-6-phosphate dehydrogenase (G6PD) or history of tendinopathy with a fluoroquinolone. - Known anatomical or pathological bronchial obstruction, or a history of bronchiectasis or post obstructive pneumonia or end-stage Chronic Obstructive Pulmonary Disease (COPD, FEV1 < 30% predicted). Subject with less severe COPD are not excluded. - Immunosuppressive therapy defined as chronic treatment with known immunosuppressive medications (including use of >10 mg of prednisone or its equivalent per day chronically, ie, for greater than 3 weeks before randomization). - Receipt of an organ or bone marrow transplant. - Presence of any of the following: a. Known human immunodeficiency virus (HIV) infection; b. Known or suspected Pseudomonas infection; c. Cystic fibrosis; d. Known or suspected Pneumocystis carinii pneumonia; e. Known or suspected 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 or to 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 10^9/L [<1000/mm^3]); 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 drug taken or investigational device used within 4 weeks before administration of the first dose of the IV test article. - Outpatient ventilator therapy within 14 days before the onset of symptoms or ventilator therapy required at the time of screening. Note: continuous positive airway pressure (CPAP) is allowed. - Current 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. - Subject who are suspected or confirmed to have at baseline viral pneumonia and who are not suspected or confirmed to have also bacterial pneumonia.
Total Enrollment:
Location and Contact Information:
Erythros Stavros Hospital *Recruiting*
Athens, , 115 26
Greece
Recruiting Dr Lazanas +30 210 64 14 730
ST. Janos Hospital *Recruiting*
Budapest, , 1125
Hungary
Recruiting Dr. Lukacs +36 1 4584639
Faculty Hospital Nitra *Recruiting*
Nitra, , 95001
Slovakia
Recruiting MD Paulovic +421 37 6545 608
Eben Donges Hospital *Recruiting*
Worcester, ,
South Africa
Recruiting Dr van Dyk +27 82 3751 618
Hospital Doctor Josep Trueta *Recruiting*
Gerona, , 17007
Spain
Recruiting Dr. Garcia-Bragado Dalmau +34 972 94 02 00
Univ. Hosp. of Infect. Disease *Recruiting*
Zagreb, , 10000
Croatia
Recruiting Dr Skerk +385 1 4603 154
Kreiskrankenhaus Luedenscheid *Recruiting*
LUEDENSCHEID, , 58515
Germany
Recruiting Prof. J. Lorenz +49 2351 463361
Faculty Hospital Trnava *Recruiting*
Trnava, , 91775
Slovakia
Recruiting MD Harnicarova +421 335536 002-9 ext. 726
Brits Medi-Clinic *Recruiting*
Brits, , 250
South Africa
Recruiting Dr Snyman +27 12 252 3318
Clin. Universitaires St Luc *Recruiting*
BRUXELLES, , 1200
Belgium
Recruiting Dr. Pieters +32 2 764 28 33
Spitalul Clin Sf. Pantelimon *Recruiting*
Bucuresti, , 21623
Romania
Recruiting Sef Dr. Cristina- Mihaela Tanaseanu +4021 255 4090
Vergelegen Medi-Clinic *Recruiting*
Somerset West, , 7130
South Africa
Recruiting Dr Engelbrecht +27 21 851 2890
Hospital Vall d'Hebron *Recruiting*
Barcelona, , 8035
Spain
Recruiting Dr Falco i Ferrer +34 93 274 6100 ext. 6090
Hospital BMA *Recruiting*
Ostrava, , 700 30
Czech Republic
Recruiting Dr Janaskova +420 59 563 3400
Tartu University Clinic *Recruiting*
Tartu, , 50406
Estonia
Recruiting MD Meriste +372 7318 932
5th MHAT *Recruiting*
Sofia, ,
Bulgaria
Recruiting Rossen Marinov +359 29268137
Bloemfontein Mediclinic Hosp. *Recruiting*
Bloemfontein, ,
South Africa
Recruiting Dr Viljoen +27 51 409 6200
Regional Hospital Tabor *Recruiting*
Tabor, , 390 01
Czech Republic
Recruiting Kamil Klenha +420 381 60 81 62
Medical Insitute Min. Interior *Recruiting*
Sofia, ,
Bulgaria
Recruiting Prof. Popov +359 2982 74653
Durbanville Medi-Clinic *Recruiting*
Durbanville, ,
South Africa
Recruiting Dr Neiuwoudt +27 21 987 1690
N.M.Sr. Karla Boromejského *Recruiting*
Praha 1, , 110 00
Czech Republic
Recruiting Libor Kamenik +420 257 197 140
Masaryk's Hospital *Recruiting*
Ústà nad Labem, , 401 13
Czech Republic
Recruiting Pavel Reiterer +420 47 568 3480
St. John's Medical College Hospital *Recruiting*
Kamataka, , 560 034
India
Recruiting Dr Mysore +91 80 2065353
General Faculty Hospital *Recruiting*
Praha 2, , 120 00
Czech Republic
Recruiting Jiri Homolka +420 22 494 1500
Hospital Universit. Dr Pesset *Recruiting*
Valencia, , 46017
Spain
Recruiting Dr Blanquer Oliva +34 96 386 2500
CSUB - Division of Infectious Diseases *Recruiting*
L'Hospitalet de Llobregat, , 8907
Spain
Recruiting Dr Gudiol +34 93 260 76 25
Hopital Erasme *Recruiting*
BRUXELLES, , 1070
Belgium
Recruiting Dr Jacobs +32 2 555 44 33
Hospital "Alexandrovska" *Recruiting*
Sofia, , 1431
Bulgaria
Recruiting Ognian Georgiev +359 29 230778
Petz Aldar County Hospital *Recruiting*
Gyor, , 9002
Hungary
Recruiting Dr. Molnar +36 96 418982
Klaipeda Hospital *Recruiting*
Klaipeda, ,
Lithuania
Recruiting Dr. Kazlauskas +370 46 396539
Hospital de Conxo *Recruiting*
Santiago de Compostela, , 15706
Spain
Recruiting Dr Valdes Cuadrado +34 981 951 778
Kasturba Medical College *Recruiting*
Mangalore, , 575 003
India
Recruiting Dr Adhikari +91 824 244 5858
Klinica tbc a respiracnich nemoci - General Faculty Hospital *Recruiting*
Ostrava-Poruba, , 708 52
Czech Republic
Recruiting Jaromir Roubec +420 59 6912240
North Estonian Hospital *Recruiting*
Tallinn, , 13419
Estonia
Recruiting Enn Pyttsepp +372 697 2060
Zentralklinik Emil von Behring *Recruiting*
Berlin, , 14109
Germany
Recruiting Prof. Hartmut Lode +(49) 030-800 222 22
Seth G.S. Medical College *Recruiting*
Mumbai, , 400 012
India
Recruiting Dr Karnad +91 22 2413 6051
Municipal Hospital -Levice *Recruiting*
Levice, , 934 01
Slovakia
Recruiting MD Antolik +421 905 506 155
Hospital of F.D. Roosevelt *Recruiting*
Banska Bystrica, , 97517
Slovakia
Recruiting MD Mazal +421 48 413 93 57
Hospital Clinic i Provincial *Recruiting*
Barcelona, ,
Spain
Recruiting Dr Torres Marti +34 93 227 57 79
Additional Information:
Study ID Numbers: 3074A1-313-WW;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081575
Other Pneumonia Studies:
1. Ventilator-associated pneumonia / Hospital-acquired pneumonia requiring mechanical ventilatory support
2. Pediatric Community-Acquired Pneumonia
3. Tigecycline versus Imipenem/Cilastatin for the Treatment of Subjects with Nosocomial Pneumonia
4. Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
5. Penicillin Prophylaxis in Sickle Cell Disease (PROPS)
Related Studies:
Other Pneumonia Clinical Trials
Other Clinical Trials
Other Trnava Clinical Trials
Intravenous Tigecycline Versus Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
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