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Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Research Site
Shreveport, Louisiana, 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, Complicated Intra-abdominal Infection
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

- 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

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

- 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.

NCT01644643
Pfizer
Completed
Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

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Descriptive Information
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 SummaryTo Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.
Detailed DescriptionAn 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
  • Complicated Urinary Tract Infection
  • Complicated Intra-abdominal Infection
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: Best Available Therapy
    Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation
  • Drug: Metronidazole
    Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion
    Other Name: Flagyl
Study Arms  ICMJE
  • Experimental: Ceftazidime - Avibactam ( CAZ-AVI)
    IV treatment
    Interventions:
    • Drug: Ceftazidime - Avibactam ( CAZ-AVI)
    • Drug: Metronidazole
  • Active Comparator: Best Available Therapy
    IV treatment
    Intervention: Drug: Best Available Therapy
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: December 1, 2014)
345
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2012)
400
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion DateSeptember 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
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,   France,   Israel,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Turkey,   Ukraine,   United States
Removed Location CountriesAustralia,   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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Study Director:Paul Newell, MBBS, MRCPAstraZeneca
PRS AccountPfizer
Verification DateAugust 2017

ICMJE     Data element required by the

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

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