Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
NCT01599806
ABOUT THIS STUDY
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- 18 to 90 years of age inclusive
- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
- Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem)
- Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis
- Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or
doripenem
- Patient's urine culture at study entry isolates more than 2 microorganisms regardless
of colony count or patient has a confirmed fungal UTI
- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
- Patient is immunocompromised
- Patient is considered unlikely to survive the 6- to 8-week study period or has a
rapidly progressive or terminal illness including septic shock which is associated
with a high risk of mortality
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Descriptive Information | ||||
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Brief Title ICMJE | Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections) | |||
Official Title ICMJE | A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults | |||
Brief Summary | The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis | |||
Detailed Description | A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 641 | |||
Original Estimated Enrollment ICMJE | 964 | |||
Actual Study Completion Date ICMJE | August 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Bulgaria, Croatia, Czechia, Germany, Israel, Italy, Korea, Republic of, Mexico, Peru, Poland, Romania, Russian Federation, Spain, Taiwan, Ukraine, United States | |||
Removed Location Countries | Belgium, Brazil, Canada, Chile, Czech Republic, France, Greece, India, Puerto Rico, Serbia, United Kingdom | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01599806 | |||
Other Study ID Numbers ICMJE | D4280C00004 2011-005722-21 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Forest Laboratories | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | August 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |