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Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
This study is currently recruiting participants.
Verified by Novexel Inc, June 2009
First Received: May 29, 2008   Last Updated: June 11, 2009   History of Changes
Sponsor: Novexel Inc
Information provided by: Novexel Inc
ClinicalTrials.gov Identifier: NCT00690378
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Urinary Tract Infections
Drug Information available for: Imipenem Ceftazidime Cilastatin sodium Cilastatin
U.S. FDA Resources

Further study details as provided by Novexel Inc:

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 ]

Estimated Enrollment: 150
Study Start Date: November 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
NXL/104 ceftazidime
Drug: NXL104/ceftazidime
125mg/500mg TID
2: Active Comparator
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

Contacts
Contact: Carole A Sable, MD 484-362-2663 carole.sable@novexel.com

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

No publications provided

Responsible Party: Novexel Inc ( Carole Sable MD Chief Medical Officer )
Study ID Numbers: NXL104/2001
Study First Received: May 29, 2008
Last Updated: June 11, 2009
ClinicalTrials.gov Identifier: NCT00690378     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2009



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