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

This study has been completed.
Sponsor:
Information provided by:
Calixa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00921024
First received: June 12, 2009
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Complicated Urinary Tract Infection
Drug: CXA-101
Drug: Ceftazidime
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Calixa Therapeutics, Inc.:

Primary Outcome Measures:
  • The primary outcome measure is the per-subject microbiological response at the TOC visit in the microbiologically evaluable (ME) and microbiological modified intent-to-treat (mMITT) populations. [ Time Frame: 19 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CXA-101
Drug: CXA-101
intravenous
Active Comparator: 2
Ceftazidime
Drug: Ceftazidime
intravenous

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921024

Locations
United States, California
Healthcare Partners Medical Group
Los Angeles, California, United States, 90015
United States, Florida
Compass Research, LLC
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, United States, 30030
United States, Indiana
Infectious Disease of Indiana, PSC
Indianapolis, Indiana, United States, 46280
United States, Mississippi
Mississippi Medical Research, LLC
Picayune, Mississippi, United States, 39466
United States, Montana
Great Falls Clinic, LLP
Butte, Montana, United States, 59701
United States, Ohio
Remington-Davis, Inc. Clinical Research
Columbus, Ohio, United States, 43215
Germany
Kreiskrankenhaus Backnang
Backnang, Germany, 71522
URO Forschungs GmbH
Berlin, Germany, 10115
Uniklinikum Giessen
Giessen, Germany, 35392
Evangelisches Krankenhaus Giessen Urologie
Giessen, Germany, 35398
Universitätsklinikum Schleswig Holstein Campus Lübeck
Lübeck, Germany, 23538
Brüderkrankenhaus St. Josef Paderborn
Paderborn, Germany, 33098
Urologische Klinik Dr. Castringius München-Planegg
Planegg, Germany, 82152
Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 Katedra i Klinika Nefrologii
Lublin, Poland, 20-954
Wojewódźki Szpital Specjalistyczny nr 1 Oddział Chorób Wewnętrznych
Tychy, Poland, 43-100
Szpital Praski p.w. Przemienienia Pańskiego Samodzielny Publiczny Zakład Opieki Zdrowotnej ll Oddział Wewnętrznych
Warszawa, Poland, 03-401
Szpital Kliniczny Dzieciątka Jezus-Centrum Leczenia Obrażeń Klinika Urologii Ogólnej, Onkologicznej Czynnościowej
Warszawa, Poland, 02-005
Szpital Bielański im.Ks. Jerzego Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnętrznych
Warszawa, Poland, 01-809
Wojewódźki Szpital Specjalistyczny Oddział Nefrologiczny
Wrocław, Poland, 51-124
Samodzielny Publiczny Szpital Wojewódźki im. Papieża Jana Pawła ll Oddział Wewnętrznych Nefrologiczno-Endokrynologiczny ze Stacją Dializ
Zamość, Poland, 22-400
Sponsors and Collaborators
Calixa Therapeutics, Inc.
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Ian Friedland, MD; Chief Medical Officer, Calixa/Cubist Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00921024     History of Changes
Other Study ID Numbers: CXA 101-03
Study First Received: June 12, 2009
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Calixa Therapeutics, Inc.:
Complicated Urinary Tract Infection
Pyelonephritis
Antimicrobial
Cephalosporin
Intravenous

Additional relevant MeSH terms:
Pyelonephritis
Urinary Tract Infections
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Infection
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014