Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
NCT ID: NCT01599806
Last Updated: 2017-09-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
641 participants
INTERVENTIONAL
2012-10-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ceftazidime - Avibactam ( CAZ-AVI)
IV treatment
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
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
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
Doripenem
IV treatment
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
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
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
Interventions
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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
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Newell, MBBS, MRCP
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Detroit, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Indiana, Pennsylvania, United States
Research Site
Rosario, , Argentina
Research Site
Pazardzhik, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Veliko Tarnovo, , Bulgaria
Research Site
Slavonski Brod, , Croatia
Research Site
Zadar, , Croatia
Research Site
Zagreb, , Croatia
Research Site
Liberec, , Czechia
Research Site
Prague, , Czechia
Research Site
Hamburg, , Germany
Research Site
Haifa, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Modena, , Italy
Research Site
Cuernavaca, MOR, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Zapopan, , Mexico
Research Site
Arequipa, , Peru
Research Site
Cercardo de Lima, , Peru
Research Site
Cusco, , Peru
Research Site
Lima, , Peru
Research Site
Trujillo, , Peru
Research Site
Bialystok, , Poland
Research Site
Sochaczew, , Poland
Research Site
Wroclaw, , Poland
Research Site
Bucharest, , Romania
Research Site
Oradea, , Romania
Research Site
Sibiu, , Romania
Research Site
Timișoara, , Romania
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Smolensk, , Russia
Research Site
Tomsk, , Russia
Research Site
Veliky Novgorod, , Russia
Research Site
Busan, , South Korea
Research Site
Jeonnam, , South Korea
Research Site
Seoul, , South Korea
Research Site
Alicante, , Spain
Research Site
Alzira (Valencia), , Spain
Research Site
Barcelona, , Spain
Research Site
Elche, , Spain
Research Site
Granada, , Spain
Research Site
Terrassa, , Spain
Research Site
Kaohsiung City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Chernivtsi, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Lutsk, , Ukraine
Research Site
Simferopol, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
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References
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Torres A, Wible M, Tawadrous M, Irani P, Stone GG, Quintana A, Debabov D, Burroughs M, Bradford PA, Kollef M. Efficacy and safety of ceftazidime/avibactam in patients with infections caused by beta-lactamase-producing Gram-negative pathogens: a pooled analysis from the Phase 3 clinical trial programme. J Antimicrob Chemother. 2023 Nov 6;78(11):2672-2682. doi: 10.1093/jac/dkad280.
Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.
Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.
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.
Other Identifiers
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2011-005722-21
Identifier Type: -
Identifier Source: secondary_id
D4280C00004
Identifier Type: -
Identifier Source: org_study_id
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