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

April 27, 2018 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
NXL/104 ceftazidime
Drug: NXL104/ceftazidime
125mg/500mg TID
ACTIVE_COMPARATOR: 2
comparator 4 x daily
Drug: Imipenem/Cilastatin
4 x daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
Time Frame: 5 to 9 days post-therapy
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
5 to 9 days post-therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
Time Frame: End of IV therapy (4 to 14 days)
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
End of IV therapy (4 to 14 days)
Clinical Outcome in CE Patients at the TOC Visit
Time Frame: 5 to 9 days post-therapy
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
5 to 9 days post-therapy
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
Time Frame: 4 to 6 weeks post-therapy
Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required
4 to 6 weeks post-therapy
Microbiological Outcome in ME Patients at the End of IV Therapy Visit
Time Frame: End of IV therapy (4 to 14 days)
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
End of IV therapy (4 to 14 days)
Microbiological Outcome in ME Patients at the LFU Visit
Time Frame: 4 to 6 weeks post-therapy
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit
Time Frame: End of IV therapy (4 to 14 days)
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit
Time Frame: End of IV therapy (4 to 14 days)
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit
Time Frame: End of IV therapy (4 to 14 days)
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit
Time Frame: End of IV therapy (4 to 14 days)
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit
Time Frame: End of IV therapy (4 to 14 days)
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
End of IV therapy (4 to 14 days)
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit
Time Frame: 5 to 9 days post-therapy
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit
Time Frame: 5 to 9 days post-therapy
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit
Time Frame: 5 to 9 days post-therapy
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit
Time Frame: 5 to 9 days post-therapy
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit
Time Frame: 5 to 9 days post-therapy
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
5 to 9 days post-therapy
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit
Time Frame: 4 to 6 weeks post-therapy
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit
Time Frame: 4 to 6 weeks post-therapy
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit
Time Frame: 4 to 6 weeks post-therapy
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
4 to 6 weeks post-therapy
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit
Time Frame: 4 to 6 weeks post-therapy
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
4 to 6 weeks post-therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Carole A Sable, MD, Novexel Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (ESTIMATE)

June 4, 2008

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXL104/2001
  • C3591013 (OTHER: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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