Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections

NCT ID: NCT00921024

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-03-11

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection

Detailed Description

This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days.

Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical signs and symptoms of infection. A Late Follow Up evaluation (21 to 28 days after the last dose of study drug) occurs for those subjects who respond to therapy. The primary assessment of effectiveness is the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy.

Conditions

Complicated Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

CXA-101

Group Type: EXPERIMENTAL

CXA-101

Intervention Type: DRUG

intravenous

2

Ceftazidime

Group Type: ACTIVE_COMPARATOR

Ceftazidime

Intervention Type: DRUG

intravenous

Interventions

CXA-101

intravenous

Intervention Type: DRUG

Ceftazidime

intravenous

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males and females 18 to 90 years of age, inclusive.

2. Pyuria (white blood cell [WBC] count > 10/µL in unspun urine or ≥ 10 per high power field in spun urine)

3. Clinical signs and/or symptoms of cUTI, either of:

a. Pyelonephritis, as indicated by both of the following: i. Fever (oral temperature ≥ 37.8°C); ii. Flank pain or costovertebral angle tenderness;

OR

b. Complicated lower UTI, as indicated by both of the following: i. At least one of the following new or worsening symptoms:

• Dysuria;
• Frequency;
• Suprapubic pain;
• Urgency

ii. At least one of the following complicating factors:

• Male gender;
• Current bladder instrumentation or indwelling urinary catheter that is expected to be removed during the course of IV study drug administration;
• Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
• Urogenital surgery within 7 days preceding administration of the first dose of study drug;
• Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.

Exclusion Criteria

1. Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial

2. Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. Drugs with only gram-positive activity (e.g. vancomycin, linezolid) are allowed

3. Complete, permanent obstruction of the urinary tract

4. Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)

5. Suspected or confirmed perinephric or intrarenal abscess

6. Suspected or confirmed prostatitis

7. Known ileal loop or vesico-ureteral reflux

8. Women who are pregnant or nursing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmad Haidar, MD

Role: PRINCIPAL_INVESTIGATOR

Mississippi Medical Research, LLC

Ryszard Gellert, MD

Role: PRINCIPAL_INVESTIGATOR

Szpital Bielański im.Ks. Jerzego Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnętrznych i Pododdział Nefrologiczny

Florian Wagenlehner, MD

Role: PRINCIPAL_INVESTIGATOR

Uniklinikum Giessen

Locations

Healthcare Partners Medical Group

Los Angeles, California, United States

Compass Research, LLC

Orlando, Florida, United States

Atlanta Institute for Medical Research, Inc.

Decatur, Georgia, United States

Infectious Disease of Indiana, PSC

Indianapolis, Indiana, United States

Mississippi Medical Research, LLC

Picayune, Mississippi, United States

Great Falls Clinic, LLP

Butte, Montana, United States

Remington-Davis, Inc. Clinical Research

Columbus, Ohio, United States

Kreiskrankenhaus Backnang

Backnang, , Germany

URO Forschungs GmbH

Berlin, , Germany

Uniklinikum Giessen

Giessen, , Germany

Evangelisches Krankenhaus Giessen Urologie

Giessen, , Germany

Universitätsklinikum Schleswig Holstein Campus Lübeck

Lübeck, , Germany

Brüderkrankenhaus St. Josef Paderborn

Paderborn, , Germany

Urologische Klinik Dr. Castringius München-Planegg

Planegg, , Germany

Samodzielny Publiczny Szpital Kliniczny nr 4 Katedra i Klinika Nefrologii

Lublin, , Poland

Wojewódźki Szpital Specjalistyczny nr 1 Oddział Chorób Wewnętrznych

Tychy, , Poland

Szpital Bielański im.Ks. Jerzego Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnętrznych

Warsaw, , Poland

Szpital Kliniczny Dzieciątka Jezus-Centrum Leczenia Obrażeń Klinika Urologii Ogólnej, Onkologicznej Czynnościowej

Warsaw, , Poland

Szpital Praski p.w. Przemienienia Pańskiego Samodzielny Publiczny Zakład Opieki Zdrowotnej ll Oddział Wewnętrznych

Warsaw, , Poland

Wojewódźki Szpital Specjalistyczny Oddział Nefrologiczny

Wroclaw, , Poland

Samodzielny Publiczny Szpital Wojewódźki im. Papieża Jana Pawła ll Oddział Wewnętrznych Nefrologiczno-Endokrynologiczny ze Stacją Dializ

Zamość, , Poland

Countries

United States; Germany; Poland

Other Identifiers

CXA 101-03

Identifier Type: OTHER

Identifier Source: secondary_id

7625-001

Identifier Type: -

Identifier Source: org_study_id