Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
NCT ID: NCT00690378
Last Updated: 2018-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2008-11-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
NXL/104 ceftazidime
NXL104/ceftazidime
125mg/500mg TID
2
comparator 4 x daily
Imipenem/Cilastatin
4 x daily
Interventions
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NXL104/ceftazidime
125mg/500mg TID
Imipenem/Cilastatin
4 x daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
* fungal urinary tract infection
* permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
* history hypersensitivity to study medication
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Carole A Sable, MD
Role: STUDY_DIRECTOR
Novexel Inc
Locations
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Alabama Research Center
Birmingham, Alabama, United States
Southeast Alabama Medical Center
Dothan, Alabama, United States
Providence Hospital
Mobile, Alabama, United States
Arizona Pulmonary Specialists LTD
Phoenix, Arizona, United States
Sharp Chula Vista Medical Center
Chula Vista, California, United States
Synergy Clinical Research Center
Escondido, California, United States
Novellus Research Sites
Fountain Valley, California, United States
Novellus Research Sites
Long Beach, California, United States
Modesto Clinical Research
Modesto, California, United States
Tri City Medical Center
Oceanside, California, United States
EStudy Site
San Jose, California, United States
Olive View UCLA Medical Center
Sylmar, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Century Clinical Research, Inc
Daytona Beach, Florida, United States
University of Florida
Jacksonville, Florida, United States
Southeast Regional Research Group
Columbus, Georgia, United States
St. Joseph's/Candler Health System
Savannah, Georgia, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States
Louisiana State University Health Services Ctr Shreveport
Shreveport, Louisiana, United States
R. Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
North Memorial Medical Center
Minneapolis, Minnesota, United States
Saint Louis University Hospital
St Louis, Missouri, United States
St. James Healthcare
Butte, Montana, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
University Hospital UMDNJ
Newark, New Jersey, United States
Albany Medical Center
Albany, New York, United States
Brookdale University Hospital
Brooklyn, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Clinical Trials of America Inc.
Winston-Salem, North Carolina, United States
Summa Health System Hospitals
Akron, Ohio, United States
Remington-Davis
Columbus, Ohio, United States
Regional Infectious Disease-Infusion Center
Lima, Ohio, United States
St Vincent's Mercy Medical Center
Toledo, Ohio, United States
Thomas Jefferson Univ Hospital
Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
Harris Methodist
Azle, Texas, United States
University of Texas MD Anderson
Houston, Texas, United States
Sentara Norfold General Hospital
Norfolk, Virginia, United States
Al-Essra hospital
Amman, , Jordan
Al-Islami Hospital
Amman, , Jordan
Jordan University Hospital
Amman, , Jordan
King Abdullah University Hospital
Irbid, , Jordan
Clinique due Levant Hospital
Beirut, , Lebanon
Dr. Rizk Clinic
Beirut, , Lebanon
Makassed General Hospital
Beirut, , Lebanon
Rafik Hariri University Hospital
Beirut, , Lebanon
Sahel General Hospital
Beirut, , Lebanon
Notre Dame Des Secours Hospital
Byblos, , Lebanon
Ain Wazein Hospital
Chouf, , Lebanon
St. Joseph Hospital
Ed Daoura, , Lebanon
Mount Lebanon Hospital
Hazmiyeh, , Lebanon
Nabatyeh Governmental Hospital
Nabatyeh, , Lebanon
Hammoud Hospital University Medical Center
Saida, , Lebanon
Labib Medical Center
Saida, , Lebanon
Saida Governmental Hospital
Saida, , Lebanon
Countries
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References
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Vazquez JA, Gonzalez Patzan LD, Stricklin D, Duttaroy DD, Kreidly Z, Lipka J, Sable C. Efficacy and safety of ceftazidime-avibactam versus imipenem-cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study. Curr Med Res Opin. 2012 Dec;28(12):1921-31. doi: 10.1185/03007995.2012.748653. Epub 2012 Nov 21.
Other Identifiers
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C3591013
Identifier Type: OTHER
Identifier Source: secondary_id
NXL104/2001
Identifier Type: -
Identifier Source: org_study_id
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