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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00921024
Recruitment Status : Completed
First Posted : June 16, 2009
Results First Posted : January 15, 2015
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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

Condition or disease Intervention/treatment Phase
Complicated Urinary Tract Infection Drug: CXA-101 Drug: Ceftazidime Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : June 30, 2009
Actual Primary Completion Date : February 25, 2010
Actual Study Completion Date : March 11, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
CXA-101
Drug: CXA-101
intravenous

Active Comparator: 2
Ceftazidime
Drug: Ceftazidime
intravenous




Primary Outcome Measures :
  1. Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population [ Time Frame: TOC; 6-9 days after last study drug administration ]
    Microbiological response is eradication for each baseline pathogen

  2. Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population. [ Time Frame: TOC; 6-9 days after last study drug administration ]
    Microbiological response is eradication for each baseline pathogen



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921024


Locations
Show Show 21 study locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
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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
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Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00921024    
Other Study ID Numbers: 7625-001
CXA 101-03 ( Other Identifier: Cubist Study Number )
First Posted: June 16, 2009    Key Record Dates
Results First Posted: January 15, 2015
Last Update Posted: October 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Keywords provided by Cubist Pharmaceuticals LLC:
Complicated Urinary Tract Infection
Pyelonephritis
Antimicrobial
Cephalosporin
Intravenous
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Pyelonephritis
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Ceftazidime
Ceftolozane
Anti-Bacterial Agents
Anti-Infective Agents