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Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

Last updated on December 12, 2019

FOR MORE INFORMATION
Study Location
Research Site
Chula Vista, California, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- 18 to 90 years of age inclusive

- Female patient is authorized to participate if at least one of the following criteria
are met:

1. Surgical sterilization

2. Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more
following cessation of all exogenous hormonal treatments

3. Age the postmenopausal range PLUS amenorrhea for 12 months or more following
cessation of all exogenous hormonal treatments

4. Patient has a negative serum pregnancy test (serum ß-human chorionic gonadotropin
[ß-hCG]) within 1 day prior to study entry, and agrees to use highly effective
contraception methods during treatment and for at least 7 days after last dose of
IV study therapy

- Intraoperative/postoperative enrollment with confirmation (presence of pus within the
abdominal cavity) of an intra-abdominal infection associated with peritonitis

- Confirmation of infection by surgical intervention within 24 hours of entry: evidence
of systemic inflammatory response; physical findings consistent with intra-abdominal
infection; supportive radiologic imaging findings of intra-abdominal infections

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

- Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12
hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other
intra-abdominal processes in which primary etiology is not likely to be infectious

- Patient has abdominal wall abscess or bowel obstruction without perforation or
ischemic bowel without perforation

- Patient has suspected intra-abdominal infections due to fungus, parasites, virus or
tuberculosis

- Patient is considered unlikely to survive the 6 to 8 week study period or has a
rapidly progressive or terminal illness, including septic shock that is associated
with a high risk of mortality

NCT01499290
Pfizer
Completed
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

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cIAIs Complicated Intra-Abdominal Infections
NCT02655419
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Official Title  ICMJE A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults
Brief Summary The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
Detailed Description A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Complicated Intra-Abdominal Infection
Intervention  ICMJE
  • Drug: CAZ-AVI
    Ceftazidime 2000 mg and 500 mg of avibactam
  • Drug: Metronidazole
    500 mg of Metronidazole
  • Drug: Meropenem
    1 gram of Meropenem
Study Arms  ICMJE
  • Experimental: CAZ-AVI + Metronidazole
    IV treatment
    Interventions:
    • Drug: CAZ-AVI
    • Drug: Metronidazole
  • Active Comparator: Meropenem
    IV treatment
    Intervention: Drug: Meropenem
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: July 3, 2014)
493
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2011)
1106
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 90 years of age inclusive
  • Female patient is authorized to participate if at least one of the following criteria are met:

    1. Surgical sterilization
    2. Age ?50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
    3. Age <50 years and postmenopausal as defined by documented LH and FSH levels in the postmenopausal range PLUS amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
    4. Patient has a negative serum pregnancy test (serum ß-human chorionic gonadotropin [ß-hCG]) within 1 day prior to study entry, and agrees to use highly effective contraception methods during treatment and for at least 7 days after last dose of IV study therapy
  • Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
  • Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections

Exclusion Criteria:

  • Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
  • Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
  • Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
  • Patient is considered unlikely to survive the 6 to 8 week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
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,   Hungary,   India,   Israel,   Latvia,   Malaysia,   Mexico,   Netherlands,   Peru,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Ukraine,   United States
Removed Location Countries Australia,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   France,   Germany,   Greece,   Italy,   Lithuania,   Poland,   Portugal,   Serbia,   Slovakia,   Turkey,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01499290
Other Study ID Numbers  ICMJE D4280C00001
2011-003893-97
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
Study Director: Paul Newell, MBBS, MRCP AstraZeneca
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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