Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

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NCT01599806

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Study Location
Research Site
Detroit, Michigan, , United States
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1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Complicated Urinary Tract Infection (cUTI) Including Acute PyelonephritisCeftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
NCT01595438
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  3. Lima, Ohio
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  8. Santa Fe,
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  16. Ruse,
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ALL GENDERS
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Complicated Urinary Tract Infection (cUTI) Including Acute PyelonephritisCeftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
NCT01599806
  1. Detroit, Michigan
  2. Saint Louis, Missouri
  3. Indiana, Pennsylvania
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  6. Sofia,
  7. Veliko Tarnovo,
  8. Slavonski Brod,
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  10. Zagreb,
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  32. Bucuresti,
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  37. Nizhniy Novgorod,
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  40. Smolensk,
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  43. Tomsk,
  44. Velikiy Novgorod,
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  58. Simferopol,
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Advanced Information
Descriptive Information
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
  • Drug: Ceftazidime - Avibactam ( CAZ-AVI)
    Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
  • Drug: Doripenem
    500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes
  • Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
    Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
  • Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
    Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Study Arms  ICMJE
  • Experimental: Ceftazidime - Avibactam ( CAZ-AVI)
    IV treatment
    Interventions:
    • Drug: Ceftazidime - Avibactam ( CAZ-AVI)
    • Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
    • Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
  • Active Comparator: Doripenem
    IV treatment
    Interventions:
    • Drug: Doripenem
    • Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
    • Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Publications *

*   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
 (submitted: February 3, 2016)		641
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2012)		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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Paul Newell, MBBS, MRCPAstraZeneca
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