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Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690378
First received: May 29, 2008
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.


Condition Intervention Phase
Complicated Urinary Tract Infection
 Drug: NXL104/ceftazidime
Drug: Imipenem/Cilastatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study Estimate Safety, Tolerability, Efficacy of NXL104/Ceftazidime vs. Comparator Followed Appropriate Oral Therapy Treatment Complicated UTI Hosp Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Estimate the by-patient microbiological response of NXL104/ceftazidime in the treatment of adult patients with complicated urinary tract infections (cUTI) [ Time Frame: 5 to 9 days post-therapy ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability profile [ Time Frame: Treatment plus 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate the clinical outcome of NXL104/ceftazidime [ Time Frame: End of IV therapy, Test of Cure visit 5 to 9 days post-therapy and late follow-up visit ] [ Designated as safety issue: No ]
  • Estimate the by-pathogen microbiological response [ Time Frame: End of IV therapy, the Test of Cure visit 5 to 9 days post-therapy and at the late follow-up visit ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NXL/104 ceftazidime
 Drug: NXL104/ceftazidime
125mg/500mg TID
Active Comparator: 2
comparator 4 x daily
 Drug: Imipenem/Cilastatin
4 x daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens

Exclusion Criteria:

  • ileal loops or vesicoureteral reflux
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690378

  Hide Study Locations
Locations
United States, Alabama
Alabama Research Center
Birmingham, Alabama, United States, 35209
Southeast Alabama Medical Center
Dothan, Alabama, United States, 36301
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Pulmonary Specialists LTD
Phoenix, Arizona, United States
United States, California
Sharp Chula Vista Medical Center
Chula Vista, California, United States, 91911
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, 92056
EStudy Site
San Jose, California, United States
Olive View UCLA Medical Center
Sylmar, California, United States
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States
United States, Florida
Century Clinical Research, Inc
Daytona Beach, Florida, United States
University of Florida
Jacksonville, Florida, United States
United States, Georgia
Southeast Regional Research Group
Columbus, Georgia, United States
St. Joseph's/Candler Health System
Savannah, Georgia, United States
United States, Kentucky
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States
United States, Louisiana
Louisiana State University Health Services Ctr Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maryland
R. Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
North Memorial Medical Center
Minneapolis, Minnesota, United States, 55422
United States, Missouri
Saint Louis University Hospital
St. Louis, Missouri, United States
United States, Montana
St. James Healthcare
Butte, Montana, United States
United States, New Jersey
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
University Hospital UMDNJ
Newark, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
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, 10305
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States
Clinical Trials of America Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Summa Health System Hospitals
Akron, Ohio, United States, 44304
Remington-Davis
Columbus, Ohio, United States
Regional Infectious Disease-Infusion Center
Lima, Ohio, United States, 45801
St Vincent's Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Thomas Jefferson Univ Hospital
Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19611
United States, Texas
Harris Methodist
Azle, Texas, United States
University of Texas MD Anderson
Houston, Texas, United States
United States, Virginia
Sentara Norfold General Hospital
Norfolk, Virginia, United States
Jordan
Jordan University Hospital
Amman, Jordan
Al-Islami Hospital
Amman, Jordan
Al-Essra hospital
Amman, Jordan
King Abdullah University Hospital
Irbid, Jordan
Lebanon
Sahel General Hospital
Beirut, Lebanon
Makassed General Hospital
Beirut, Lebanon
Clinique due Levant Hospital
Beirut, Lebanon
Dr. Rizk Clinic
Beirut, Lebanon
Rafik Hariri University Hospital
Beirut, Lebanon
Notre Dame Des Secours Hospital
Byblos, Lebanon
Ain Wazein Hospital
Chouf, Lebanon
St. Joseph Hospital
Dora, Lebanon
Mount Lebanon Hospital
Hazmieh, Lebanon
Nabatyeh Governmental Hospital
Nabatyeh, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Saida Governmental Hospital
Saida, Lebanon
Labib Medical Center
Saida, Lebanon
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carole A Sable, MD Novexel Inc
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carole Sable MD Chief Medical Officer, Novexel Inc
ClinicalTrials.gov Identifier: NCT00690378     History of Changes
Other Study ID Numbers: NXL104/2001
Study First Received: May 29, 2008
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Ceftazidime
Imipenem
Cilastatin
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013