Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
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
2 other identifiers
interventional
137
3 countries
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
May 25, 2018
CompletedMay 25, 2018
March 1, 2018
1.6 years
May 29, 2008
September 1, 2017
April 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
5 to 9 days post-therapy
Secondary Outcomes (19)
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
End of IV therapy (4 to 14 days)
Clinical Outcome in CE Patients at the TOC Visit
5 to 9 days post-therapy
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
4 to 6 weeks post-therapy
Microbiological Outcome in ME Patients at the End of IV Therapy Visit
End of IV therapy (4 to 14 days)
Microbiological Outcome in ME Patients at the LFU Visit
4 to 6 weeks post-therapy
- +14 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALNXL/104 ceftazidime
2
ACTIVE COMPARATORcomparator 4 x daily
Interventions
Eligibility Criteria
You may qualify if:
- Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (59)
Alabama Research Center
Birmingham, Alabama, 35209, United States
Southeast Alabama Medical Center
Dothan, Alabama, 36301, United States
Providence Hospital
Mobile, Alabama, 36608, United States
Arizona Pulmonary Specialists LTD
Phoenix, Arizona, United States
Sharp Chula Vista Medical Center
Chula Vista, California, 91911, United States
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, 92056, United States
EStudy Site
San Jose, California, United States
Olive View UCLA Medical Center
Sylmar, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Century Clinical Research, Inc
Daytona Beach, Florida, United States
University of Florida
Jacksonville, Florida, United States
Southeast Regional Research Group
Columbus, Georgia, United States
St. Joseph's/Candler Health System
Savannah, Georgia, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States
Louisiana State University Health Services Ctr Shreveport
Shreveport, Louisiana, 71103, United States
R. Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
North Memorial Medical Center
Minneapolis, Minnesota, 55422, United States
Saint Louis University Hospital
St Louis, Missouri, United States
St. James Healthcare
Butte, Montana, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
University Hospital UMDNJ
Newark, New Jersey, United States
Albany Medical Center
Albany, New York, 12208, United States
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, 10305, United States
Mission Hospital
Asheville, North Carolina, United States
Clinical Trials of America Inc.
Winston-Salem, North Carolina, 27103, United States
Summa Health System Hospitals
Akron, Ohio, 44304, United States
Remington-Davis
Columbus, Ohio, United States
Regional Infectious Disease-Infusion Center
Lima, Ohio, 45801, United States
St Vincent's Mercy Medical Center
Toledo, Ohio, 43608, United States
Thomas Jefferson Univ Hospital
Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611, United States
Harris Methodist
Azle, Texas, United States
University of Texas MD Anderson
Houston, Texas, United States
Sentara Norfold General Hospital
Norfolk, Virginia, United States
Al-Essra hospital
Amman, Jordan
Al-Islami Hospital
Amman, Jordan
Jordan University Hospital
Amman, Jordan
King Abdullah University Hospital
Irbid, Jordan
Clinique due Levant Hospital
Beirut, Lebanon
Dr. Rizk Clinic
Beirut, Lebanon
Makassed General Hospital
Beirut, Lebanon
Rafik Hariri University Hospital
Beirut, Lebanon
Sahel General Hospital
Beirut, Lebanon
Notre Dame Des Secours Hospital
Byblos, Lebanon
Ain Wazein Hospital
Chouf, Lebanon
St. Joseph Hospital
Ed Daoura, Lebanon
Mount Lebanon Hospital
Hazmiyeh, Lebanon
Nabatyeh Governmental Hospital
Nabatyeh, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Labib Medical Center
Saida, Lebanon
Saida Governmental Hospital
Saida, Lebanon
Related Publications (1)
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.
PMID: 23145859DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
- STUDY DIRECTOR
Carole A Sable, MD
Novexel Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 4, 2008
Study Start
November 1, 2008
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
May 25, 2018
Results First Posted
May 25, 2018
Record last verified: 2018-03