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

Primary Purpose

Complicated Urinary Tract Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NXL104/ceftazidime
Imipenem/Cilastatin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Urinary Tract Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Research Center
  • Southeast Alabama Medical Center
  • Providence Hospital
  • Arizona Pulmonary Specialists LTD
  • Sharp Chula Vista Medical Center
  • Synergy Clinical Research Center
  • Novellus Research Sites
  • Novellus Research Sites
  • Modesto Clinical Research
  • Tri City Medical Center
  • EStudy Site
  • Olive View UCLA Medical Center
  • Christiana Care Health Services
  • Century Clinical Research, Inc
  • University of Florida
  • Southeast Regional Research Group
  • St. Joseph's/Candler Health System
  • Four Rivers Clinical Research Inc
  • Louisiana State University Health Services Ctr Shreveport
  • R. Adams Cowley Shock Trauma Center
  • Henry Ford Hospital
  • North Memorial Medical Center
  • Saint Louis University Hospital
  • St. James Healthcare
  • Jersey Shore University Medical Center
  • Newark Beth Israel Medical Center
  • University Hospital UMDNJ
  • Albany Medical Center
  • Brookdale University Hospital
  • Vassar Brothers Medical Center
  • Staten Island University Hospital
  • Mission Hospital
  • Clinical Trials of America Inc.
  • Summa Health System Hospitals
  • Remington-Davis
  • Regional Infectious Disease-Infusion Center
  • St Vincent's Mercy Medical Center
  • Thomas Jefferson Univ Hospital
  • Reading Hospital and Medical Center
  • Harris Methodist
  • University of Texas MD Anderson
  • Sentara Norfold General Hospital
  • Al-Essra hospital
  • Al-Islami Hospital
  • Jordan University Hospital
  • King Abdullah University Hospital
  • Clinique due Levant Hospital
  • Dr. Rizk Clinic
  • Makassed General Hospital
  • Rafik Hariri University Hospital
  • Sahel General Hospital
  • Notre Dame Des Secours Hospital
  • Ain Wazein Hospital
  • St. Joseph Hospital
  • Mount Lebanon Hospital
  • Nabatyeh Governmental Hospital
  • Hammoud Hospital University Medical Center
  • Labib Medical Center
  • Saida Governmental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

NXL/104 ceftazidime

comparator 4 x daily

Outcomes

Primary Outcome Measures

Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2008
Last Updated
April 27, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00690378
Brief Title
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Urinary Tract Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
NXL/104 ceftazidime
Arm Title
2
Arm Type
Active Comparator
Arm Description
comparator 4 x daily
Intervention Type
Drug
Intervention Name(s)
NXL104/ceftazidime
Intervention Description
125mg/500mg TID
Intervention Type
Drug
Intervention Name(s)
Imipenem/Cilastatin
Intervention Description
4 x daily
Primary Outcome Measure Information:
Title
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
5 to 9 days post-therapy
Secondary Outcome Measure Information:
Title
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
Description
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Time Frame
End of IV therapy (4 to 14 days)
Title
Clinical Outcome in CE Patients at the TOC Visit
Description
Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Time Frame
5 to 9 days post-therapy
Title
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
Description
Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required
Time Frame
4 to 6 weeks post-therapy
Title
Microbiological Outcome in ME Patients at the End of IV Therapy Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
End of IV therapy (4 to 14 days)
Title
Microbiological Outcome in ME Patients at the LFU Visit
Description
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame
4 to 6 weeks post-therapy
Title
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
End of IV therapy (4 to 14 days)
Title
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
End of IV therapy (4 to 14 days)
Title
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
End of IV therapy (4 to 14 days)
Title
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
End of IV therapy (4 to 14 days)
Title
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
End of IV therapy (4 to 14 days)
Title
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
5 to 9 days post-therapy
Title
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
5 to 9 days post-therapy
Title
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
5 to 9 days post-therapy
Title
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
5 to 9 days post-therapy
Title
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit
Description
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame
5 to 9 days post-therapy
Title
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit
Description
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame
4 to 6 weeks post-therapy
Title
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit
Description
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame
4 to 6 weeks post-therapy
Title
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit
Description
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame
4 to 6 weeks post-therapy
Title
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit
Description
Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame
4 to 6 weeks post-therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carole A Sable, MD
Organizational Affiliation
Novexel Inc
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Research Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Southeast Alabama Medical Center
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Providence Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Pulmonary Specialists LTD
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Sharp Chula Vista Medical Center
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Synergy Clinical Research Center
City
Escondido
State/Province
California
Country
United States
Facility Name
Novellus Research Sites
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
Novellus Research Sites
City
Long Beach
State/Province
California
Country
United States
Facility Name
Modesto Clinical Research
City
Modesto
State/Province
California
Country
United States
Facility Name
Tri City Medical Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
EStudy Site
City
San Jose
State/Province
California
Country
United States
Facility Name
Olive View UCLA Medical Center
City
Sylmar
State/Province
California
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Century Clinical Research, Inc
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Southeast Regional Research Group
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
St. Joseph's/Candler Health System
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Four Rivers Clinical Research Inc
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
Louisiana State University Health Services Ctr Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
R. Adams Cowley Shock Trauma Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
North Memorial Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
St. James Healthcare
City
Butte
State/Province
Montana
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
University Hospital UMDNJ
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Brookdale University Hospital
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Clinical Trials of America Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Summa Health System Hospitals
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Remington-Davis
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Regional Infectious Disease-Infusion Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
St Vincent's Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Thomas Jefferson Univ Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Harris Methodist
City
Azle
State/Province
Texas
Country
United States
Facility Name
University of Texas MD Anderson
City
Houston
State/Province
Texas
Country
United States
Facility Name
Sentara Norfold General Hospital
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Al-Essra hospital
City
Amman
Country
Jordan
Facility Name
Al-Islami Hospital
City
Amman
Country
Jordan
Facility Name
Jordan University Hospital
City
Amman
Country
Jordan
Facility Name
King Abdullah University Hospital
City
Irbid
Country
Jordan
Facility Name
Clinique due Levant Hospital
City
Beirut
Country
Lebanon
Facility Name
Dr. Rizk Clinic
City
Beirut
Country
Lebanon
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
Facility Name
Rafik Hariri University Hospital
City
Beirut
Country
Lebanon
Facility Name
Sahel General Hospital
City
Beirut
Country
Lebanon
Facility Name
Notre Dame Des Secours Hospital
City
Byblos
Country
Lebanon
Facility Name
Ain Wazein Hospital
City
Chouf
Country
Lebanon
Facility Name
St. Joseph Hospital
City
Dora
Country
Lebanon
Facility Name
Mount Lebanon Hospital
City
Hazmieh
Country
Lebanon
Facility Name
Nabatyeh Governmental Hospital
City
Nabatyeh
Country
Lebanon
Facility Name
Hammoud Hospital University Medical Center
City
Saida
Country
Lebanon
Facility Name
Labib Medical Center
City
Saida
Country
Lebanon
Facility Name
Saida Governmental Hospital
City
Saida
Country
Lebanon

12. IPD Sharing Statement

Citations:
PubMed Identifier
23145859
Citation
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.
Results Reference
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Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

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