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

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Research Site
Sylmar, California, United States
Contact
1-800-718-1021
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

NCT01595438
Pfizer
Completed
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

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Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
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
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
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
  • 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
  • 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)
Wagenlehner FM, Sobel JD, Newell P, Armstrong J, Huang X, Stone GG, Yates K, Gasink LB. Ceftazidime-avibactam Versus Doripenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: RECAPTURE, a Phase 3 Randomized Trial Program. Clin Infect Dis. 2016 Sep 15;63(6):754-762. doi: 10.1093/cid/ciw378. Epub 2016 Jun 16.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
598
August 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Bulgaria,   Croatia,   Czechia,   Germany,   Greece,   Hungary,   Israel,   Japan,   Korea, Republic of,   Mexico,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Taiwan,   Turkey,   Ukraine,   United States
Belgium,   Canada,   Czech Republic,   France,   India,   Puerto Rico
 
NCT01595438
D4280C00002
2011-005721-43
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Forest Laboratories
Study Director: Paul Newell, MBBS, MRCP AstraZeneca
Pfizer
August 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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