Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
NCT ID: NCT01595438
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
598 participants
INTERVENTIONAL
2012-10-31
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GSK2251052 in Complicated Urinary Tract Infection
NCT01381549
Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections
NCT03687255
A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
NCT00965848
Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections
NCT02753946
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
NCT00515034
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Forest Laboratories
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul Newell, MBBS, MRCP
Role: STUDY_DIRECTOR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Sylmar, California, United States
Research Site
Royal Oak, Michigan, United States
Research Site
Lima, Ohio, United States
Research Site
Corrientes, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Santa Fe, , Argentina
Research Site
Belo Horizonte, , Brazil
Research Site
Campinas/SP, , Brazil
Research Site
Salvador, , Brazil
Research Site
São José Do Rio Preto - SP, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Vila Clementino, , Brazil
Research Site
Pleven, , Bulgaria
Research Site
Rousse, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Zagreb, , Croatia
Research Site
Kyjov, , Czechia
Research Site
Opava, , Czechia
Research Site
Jena, , Germany
Research Site
Wuppertal, , Germany
Research Site
Athens, , Greece
Research Site
Budapest, , Hungary
Research Site
Nagykanizsa, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Jerusalem, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Safed, , Israel
Research Site
Fukuoka, , Japan
Research Site
Koshigaya-shi, , Japan
Research Site
Kyoto, , Japan
Research Site
Nagoya, , Japan
Research Site
Nara, , Japan
Research Site
Ōita, , Japan
Research Site
Sendai, , Japan
Research Site
Sunto-gun, , Japan
Research Site
Tokushima, , Japan
Research Site
Ueda-shi, , Japan
Research Site
Utsunomiya, , Japan
Research Site
Guadalajara, Jalisco, , Mexico
Research Site
Inowrocław, , Poland
Research Site
Krakow, , Poland
Research Site
Warsaw, , Poland
Research Site
Lisbon, , Portugal
Research Site
Brasov, , Romania
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Craiova, , Romania
Research Site
Iași, , Romania
Research Site
Arkhangelsk, , Russia
Research Site
Krasnodar, , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Penza, , Russia
Research Site
Rostov-on-Don, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saratov, , Russia
Research Site
Vsevolozhsk, , Russia
Research Site
Belgrade, , Serbia
Research Site
Kragujevac, , Serbia
Research Site
Poprad, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Trnava, , Slovakia
Research Site
Žilina, , Slovakia
Research Site
Busan, , South Korea
Research Site
Seoul, , South Korea
Research Site
Wŏnju, , South Korea
Research Site
Chiayi City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Diyarbakır, , Turkey (Türkiye)
Research Site
Cherkasy, , Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Mykolaiv, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Review additional registry numbers or institutional identifiers associated with this trial.
2011-005721-43
Identifier Type: -
Identifier Source: secondary_id
D4280C00002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.