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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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