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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Intra-Abdominal Infection

Intervention: CAZ-AVI (Drug); Metronidazole (Drug); Meropenem (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Paul Newell, MBBS, MRCP, Study Director, Affiliation: AstraZeneca

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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Cure as Measured by proportion of patients meeting cure criteria in the microbiological modified Intent-To-Treat analysis set.

Secondary outcome:

The proportion of patients with clinical cure in the microbiologically evaluable and extended microbiologically evaluable analysis set

The proportion of patients with clinical cure in the microbiological modified intent-to-treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets

The proportion of patients with clinical cure in the clinically evaluable analysis set.

The proportion of patients with a favorable per-patient microbiological response in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets

The proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets

The favorable per-pathogen microbiologic response by minimum inhibitory concentration (MIC) categories in the microbiological modified intent to treat, microbiologically evaluable, and extended microbiologically evaluable analysis sets

Favorable per-patient clinical response & microbiological response for patients infected with ceftazidime-resistant pathogens in microbiological modified intent to treat, microbiologically evaluable & extended microbiologically evaluable analysis sets

Proportion of patients with favorable per-pathogen microbiological response for patients infected with ceftazidime-resistant pathogens in microbiological modified ITT, microbiologically evaluable and extended microbiologically evaluable analysis sets

The time to first defervescence in the clinically evaluable, microbiologically evaluable, and extended microbiologically evaluable analysis sets for patients who have fever at study entry

The safety and tolerability by incidence and severity of adverse events and serious adverse events, vital signs, clinical laboratory tests, ECGs and physical exams.

Pharmacokinetics: maximum concentration (Cmax), minimum concentration, area under the plasma concentration time curve at steady state, and terminal half-life

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

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Córdoba, Argentina

Research Site, Rosario, Argentina

Research Site, Ruse, Bulgaria

Research Site, Varna, Bulgaria

Research Site, Zagreb, Croatia

Research Site, Decin, Czech Republic

Research Site, Hradec Kralove, Czech Republic

Research Site, Jihlava, Czech Republic

Research Site, Olomouc, Czech Republic

Research Site, Praha 10, Czech Republic

Research Site, Praha 5, Czech Republic

Research Site, Teplice, Czech Republic

Research Site, Budapest, Hungary

Research Site, Székesfehérvár, Hungary

Research Site, Bangalore, India

Research Site, Pune, India

Research Site, Trivandrum, India

Research Site, Vadodara, India

Research Site, Hadera, Israel

Research Site, Haifa, Israel

Research Site, Riga, Latvia

Research Site, Alor Setar, Malaysia

Research Site, Durango, Mexico

Research Site, Guadalajara, Jalisco, Mexico

Research Site, Mexico City, Mexico

Research Site, Enschede, Netherlands

Research Site, s-Hertogenbosch, Netherlands

Research Site, Arequipa, Peru

Research Site, Cercardo de Lima, Peru

Research Site, Lima, Peru

Research Site, Trujillo, Peru

Research Site, Cluj-Napoca, Romania

Research Site, Iasi, Romania

Research Site, Kemerovo, Russian Federation

Research Site, Moscow, Russian Federation

Research Site, Saratov, Russian Federation

Research Site, Vsevolozhsk, Russian Federation

Research Site, Pretoria, South Africa

Research Site, Alcorcón, Spain

Research Site, Elche, Spain

Research Site, Sabadell(Barcelona), Spain

Research Site, Kaohsiung, Taiwan

Research Site, Taichung, Taiwan

Research Site, Tainan, Taiwan

Research Site, Taipei, Taiwan

Research Site, Bangkok, Thailand

Research Site, Khon Kaen, Thailand

Research Site, Phisanulok, Thailand

Research Site, Dnipropetrovsk, Ukraine

Research Site, Ivano-Frankivsk, Ukraine

Research Site, Kharkov, Ukraine

Research Site, Kyiv, Ukraine

Research Site, Zaporizhzhya, Ukraine

Research Site, Chula Vista, California, United States

Research Site, San Diego, California, United States

Research Site, St. Louis, Missouri, United States

Research Site, Somers Point, New Jersey, United States

Additional Information

Starting date: March 2012
Last updated: July 3, 2014

Page last updated: August 23, 2015

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