Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
NCT01644643
ABOUT THIS STUDY
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- Patient must be ≥18 and ≤90 years of age
- 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
- Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection
- Patient has an APACHE II score >30 (cIAI patients only)
- Patient has an infection due to Gram negative pathogen that is unlikely to respond to
CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
Patient is immunocompromised
- Patient has a rapidly progressive or terminal illness with a high risk of mortality
due to any cause, including acute hepatic failure, respiratory failure or severe
septic shock such that they are unlikely to survive the 4- to 5-week study period.
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Descriptive Information | ||||
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Brief Title ICMJE | Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens | |||
Official Title ICMJE | An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens | |||
Brief Summary | To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections. | |||
Detailed Description | An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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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 | 345 | |||
Original Estimated Enrollment ICMJE | 400 | |||
Actual Study Completion Date ICMJE | September 2014 | |||
Actual Primary Completion Date | September 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, France, Israel, Korea, Republic of, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Turkey, Ukraine, United States | |||
Removed Location Countries | Australia, Belgium, Brazil, Chile, China, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, India, Italy, Japan, Puerto Rico, Taiwan, United Kingdom | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01644643 | |||
Other Study ID Numbers ICMJE | D4280C00006 2012-000726-21 | |||
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 |