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

Complicated Urinary Tract Infection Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA-101 and Intravenous Ceftazidime in Complicated Urinary Tract Infection, Including Pyelonephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921024
• Other study ID #: 7625-001
• Secondary ID: CXA 101-03
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2009
• Est. completion date: March 11, 2010

Study information

• Verified date: September 2018
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 11, 2010
• Est. primary completion date: February 25, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Urinary Tract Infection
• Infection
• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• CXA-101
intravenous
• Ceftazidime
intravenous

Locations

Country	Name	City	State
Germany	Kreiskrankenhaus Backnang	Backnang
Germany	URO Forschungs GmbH	Berlin
Germany	Evangelisches Krankenhaus Giessen Urologie	Giessen
Germany	Uniklinikum Giessen	Giessen
Germany	Universitätsklinikum Schleswig Holstein Campus Lübeck	Lübeck
Germany	Brüderkrankenhaus St. Josef Paderborn	Paderborn
Germany	Urologische Klinik Dr. Castringius München-Planegg	Planegg
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4 Katedra i Klinika Nefrologii	Lublin
Poland	Wojewódzki Szpital Specjalistyczny nr 1 Oddzial Chorób Wewnetrznych	Tychy
Poland	Szpital Bielanski im.Ks. Jerzego Popieluszki Samodzielny Publiczny Zaklad Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnetrznych	Warszawa
Poland	Szpital Kliniczny Dzieciatka Jezus-Centrum Leczenia Obrazen Klinika Urologii Ogólnej, Onkologicznej Czynnosciowej	Warszawa
Poland	Szpital Praski p.w. Przemienienia Panskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej ll Oddzial Wewnetrznych	Warszawa
Poland	Wojewódzki Szpital Specjalistyczny Oddzial Nefrologiczny	Wroclaw
Poland	Samodzielny Publiczny Szpital Wojewódzki im. Papieza Jana Pawla ll Oddzial Wewnetrznych Nefrologiczno-Endokrynologiczny ze Stacja Dializ	Zamosc
United States	Great Falls Clinic, LLP	Butte	Montana
United States	Remington-Davis, Inc. Clinical Research	Columbus	Ohio
United States	Atlanta Institute for Medical Research, Inc.	Decatur	Georgia
United States	Infectious Disease of Indiana, PSC	Indianapolis	Indiana
United States	Healthcare Partners Medical Group	Los Angeles	California
United States	Compass Research, LLC	Orlando	Florida
United States	Mississippi Medical Research, LLC	Picayune	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population	Microbiological response is eradication for each baseline pathogen	TOC; 6-9 days after last study drug administration
Primary	Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.	Microbiological response is eradication for each baseline pathogen	TOC; 6-9 days after last study drug administration