ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

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: NCT01345929
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : January 15, 2015
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Complicated Urinary Tract Infection
Pyelonephritis
Interventions: Drug: CXA-201
Drug: Levofloxacin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two P3 protocols were initiated (NCT01345929 and NCT01345955) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. A total of 1083 subjects were randomized to both arms, 558 to NCT01345929 and 525 to NCT01345955. Of these, 552 and 516 received treatment.

Reporting Groups
  Description
CXA-201 as Treatment for cUTI

CXA-201 IV infusion (1500mg q8) for 7 days

CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days

Of the 1083 subjects in the integrated analysis set, 533 received CXA.

Levofloxacin as Treatment for cUTI

Levofloxacin IV infusion (750mg qd) for 7 days

Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days

Of the 1083 subjects in the integrated analysis set, 535 received levofloxacin.


Participant Flow:   Overall Study
    CXA-201 as Treatment for cUTI   Levofloxacin as Treatment for cUTI
STARTED   533   535 
COMPLETED   512   516 
NOT COMPLETED   21   19 
Withdrawal by Subject                9                8 
Lost to Follow-up                9                9 
Adverse Event                0                1 
Didn't meet eligibility criteria                2                0 
40,000 CFU/ML                1                0 
Patient withdrawal                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CXA-201 as Treatment for cUTI

CXA-201 IV infusion (1500mg q8) for 7 days

CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days

Levofloxacin as Treatment for cUTI

Levofloxacin IV infusion (750mg qd) for 7 days

Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days

Total Total of all reporting groups

Baseline Measures
   CXA-201 as Treatment for cUTI   Levofloxacin as Treatment for cUTI   Total 
Overall Participants Analyzed 
[Units: Participants]
 533   535   1068 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.7  (19.52)   48.6  (20.05)   49.1  (19.79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      374  70.2%      380  71.0%      754  70.6% 
Male      159  29.8%      155  29.0%      314  29.4% 


  Outcome Measures

1.  Primary:   The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population   [ Time Frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) ]

2.  Secondary:   The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.   [ Time Frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Two identical P3 protocols were initiated (NCT01345929 and NCT01345955) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. These analyses are presented here.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Obi Umeh, Vice President Global Medical Sciences
Organization: Cubist Pharmaceuticals, Inc.
phone: 781-860-8415
e-mail: obiamiwe.umeh@cubist.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01345929     History of Changes
Obsolete Identifiers: NCT01345955
Other Study ID Numbers: 7625A-005
CXA-cUTI-10-04 ( Other Identifier: Cubist Study Number )
CXA-cUTI-10-05 ( Other Identifier: Cubist Study # for Study 7625A-006 )
First Submitted: April 28, 2011
First Posted: May 2, 2011
Results First Submitted: January 9, 2015
Results First Posted: January 15, 2015
Last Update Posted: May 1, 2017