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

NCT00921024 | Completed Phase 2 Results

• 2 other identifiers: 7625-001CXA 101-03
• Study Type: interventional
• Target: 129
• Locations: 3 countries
• Sites: 21

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

Conditions

Complicated Urinary Tract Infection

Keywords

Complicated Urinary Tract Infection; Pyelonephritis; Antimicrobial; Cephalosporin; Intravenous

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

CXA-101

Drug: CXA-101

2

ACTIVE COMPARATOR

Ceftazidime

Drug: Ceftazidime

Interventions

CXA-101 DRUG

intravenous

1

Ceftazidime DRUG

intravenous

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 to 90 years of age, inclusive.
• Pyuria (white blood cell \[WBC\] count \> 10/µL in unspun urine or ≥ 10 per high power field in spun urine)
• 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;
• 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.

You may not qualify if:

• Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial
• 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
• Complete, permanent obstruction of the urinary tract
• Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)
• Suspected or confirmed perinephric or intrarenal abscess
• Suspected or confirmed prostatitis
• Known ileal loop or vesico-ureteral reflux
• Women who are pregnant or nursing

Sponsors & Collaborators

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

Study Sites (21)

Healthcare Partners Medical Group

Los Angeles, California, 90015, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Atlanta Institute for Medical Research, Inc.

Decatur, Georgia, 30030, United States

Location

Infectious Disease of Indiana, PSC

Indianapolis, Indiana, 46280, United States

Location

Mississippi Medical Research, LLC

Picayune, Mississippi, 39466, United States

Location

Great Falls Clinic, LLP

Butte, Montana, 59701, United States

Location

Remington-Davis, Inc. Clinical Research

Columbus, Ohio, 43215, United States

Location

Kreiskrankenhaus Backnang

Backnang, 71522, Germany

Location

URO Forschungs GmbH

Berlin, 10115, Germany

Location

Uniklinikum Giessen

Giessen, 35392, Germany

Location

Evangelisches Krankenhaus Giessen Urologie

Giessen, 35398, Germany

Location

Universitätsklinikum Schleswig Holstein Campus Lübeck

Lübeck, 23538, Germany

Location

Brüderkrankenhaus St. Josef Paderborn

Paderborn, 33098, Germany

Location

Urologische Klinik Dr. Castringius München-Planegg

Planegg, 82152, Germany

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 Katedra i Klinika Nefrologii

Lublin, 20-954, Poland

Location

Wojewódźki Szpital Specjalistyczny nr 1 Oddział Chorób Wewnętrznych

Tychy, 43-100, Poland

Location

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

Warsaw, 01-809, Poland

Location

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

Warsaw, 02-005, Poland

Location

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

Warsaw, 03-401, Poland

Location

Wojewódźki Szpital Specjalistyczny Oddział Nefrologiczny

Wroclaw, 51-124, Poland

Location

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

Zamość, 22-400, Poland

Location

MeSH Terms

Conditions

Pyelonephritis

Interventions

ceftolozane; Ceftazidime

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Obi Umeh, Vice President Global Medical Sciences
• Organization: Cubist Pharmaceuticals, Inc.

obiamiwe.umeh@cubist.com

781-860-8415

Study Officials

• Ahmad Haidar, MD

  Mississippi Medical Research, LLC

  PRINCIPAL INVESTIGATOR

• Ryszard Gellert, MD

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

  PRINCIPAL INVESTIGATOR

• Florian Wagenlehner, MD

  Uniklinikum Giessen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 16, 2009
• Study Start: June 30, 2009
• Primary Completion: February 25, 2010
• Study Completion: March 11, 2010
• Last Updated: October 18, 2018
• Results First Posted: January 15, 2015

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (7); US (7); PL (7)