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

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ClinicalTrials.gov Identifier: NCT01345929
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : January 15, 2015
Last Update Posted : October 25, 2018
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
Enrollment 558
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title CXA-201 as Treatment for cUTI Levofloxacin as Treatment for cUTI
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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 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.

Period Title: Overall Study
Started 533 535
Completed 512 516
Not Completed 21 19
Reason Not Completed
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
Arm/Group Title CXA-201 as Treatment for cUTI Levofloxacin as Treatment for cUTI Total
Hide Arm/Group Description

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

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

Levofloxacin IV infusion (750mg qd) for 7 days

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

Total of all reporting groups
Overall Number of Baseline Participants 533 535 1068
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 533 participants 535 participants 1068 participants
49.7  (19.52) 48.6  (20.05) 49.1  (19.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 533 participants 535 participants 1068 participants
Female
374
  70.2%
380
  71.0%
754
  70.6%
Male
159
  29.8%
155
  29.0%
314
  29.4%
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mMITT: Treated subjects, with baseline pathogen.
Arm/Group Title CXA-201 as Treatment for cUTI Levofloxacin as Treatment for cUTI
Hide Arm/Group Description:

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

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

Levofloxacin IV infusion (750mg qd) for 7 days

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

Overall Number of Participants Analyzed 398 402
Measure Type: Number
Unit of Measure: percentage of subjects
76.9 68.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CXA-201 as Treatment for cUTI, Levofloxacin as Treatment for cUTI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
2.31 to 14.57
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ME: Treated patients, with baseline pathogen, complied with protocol.
Arm/Group Title CXA-201 as Treatment for cUTI Levofloxacin as Treatment for cUTI
Hide Arm/Group Description:

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

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

Levofloxacin IV infusion (750mg qd) for 7 days

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

Overall Number of Participants Analyzed 341 353
Measure Type: Number
Unit of Measure: percentage of subjects
83.3 75.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CXA-201 as Treatment for cUTI, Levofloxacin as Treatment for cUTI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
1.95 to 13.97
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CXA-201 as Treatment for cUTI Levofloxacin as Treatment for cUTI
Hide Arm/Group Description

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

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

Levofloxacin IV infusion (750mg qd) for 7 days

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

All-Cause Mortality
CXA-201 as Treatment for cUTI Levofloxacin as Treatment for cUTI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CXA-201 as Treatment for cUTI Levofloxacin as Treatment for cUTI
Affected / at Risk (%) Affected / at Risk (%)
Total   15/533 (2.81%)   18/535 (3.36%) 
Cardiac disorders     
Angina unstable  1  0/533 (0.00%)  1/535 (0.19%) 
Cardiac failure congestive  1  0/533 (0.00%)  1/535 (0.19%) 
Eye disorders     
Diabetic retinopaty  1  1/533 (0.19%)  0/535 (0.00%) 
Gastrointestinal disorders     
Gastric ulcer  1  0/533 (0.00%)  1/535 (0.19%) 
General disorders     
Hernia obstructive  1  0/533 (0.00%)  1/535 (0.19%) 
Immune system disorders     
Contrast media allergy  1  0/533 (0.00%)  1/535 (0.19%) 
Infections and infestations     
Urinary tract infection  1  3/533 (0.56%)  2/535 (0.37%) 
Pneumonia  1  2/533 (0.38%)  0/535 (0.00%) 
Urosepsis  1  2/533 (0.38%)  0/535 (0.00%) 
Abdominal abscess  1  1/533 (0.19%)  0/535 (0.00%) 
Clostridium difficile colitis  1  1/533 (0.19%)  0/535 (0.00%) 
Diverticulitis  1  1/533 (0.19%)  0/535 (0.00%) 
Liver abscess  1  1/533 (0.19%)  0/535 (0.00%) 
Pseudomembranous colitis  1  1/533 (0.19%)  0/535 (0.00%) 
Pyelonephritis  1  0/533 (0.00%)  6/535 (1.12%) 
Emphysematous pyelonephritis  1  0/533 (0.00%)  1/535 (0.19%) 
Escherichia sepsis  1  0/533 (0.00%)  1/535 (0.19%) 
Pyelonephritis acute  1  0/533 (0.00%)  1/535 (0.19%) 
Sepsis  1  0/533 (0.00%)  1/535 (0.19%) 
Injury, poisoning and procedural complications     
Pneumothorax traumatic  1  0/533 (0.00%)  1/535 (0.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  2/533 (0.38%)  0/535 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  0/533 (0.00%)  1/535 (0.19%) 
Renal and urinary disorders     
Calculus urinary  1  1/533 (0.19%)  0/535 (0.00%) 
Renal colic  1  1/533 (0.19%)  0/535 (0.00%) 
Urinary retention  1  1/533 (0.19%)  0/535 (0.00%) 
Renal tubular acidosis  1  0/533 (0.00%)  1/535 (0.19%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/533 (0.00%)  1/535 (0.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CXA-201 as Treatment for cUTI Levofloxacin as Treatment for cUTI
Affected / at Risk (%) Affected / at Risk (%)
Total   108/533 (20.26%)   101/535 (18.88%) 
Gastrointestinal disorders     
Abdominal pain upper  1  7/533 (1.31%)  6/535 (1.12%) 
Constipation  1  21/533 (3.94%)  17/535 (3.18%) 
Diarrhoea  1  10/533 (1.88%)  23/535 (4.30%) 
Nausea  1  15/533 (2.81%)  9/535 (1.68%) 
Vomiting  1  6/533 (1.13%)  6/535 (1.12%) 
General disorders     
Pyrexia  1  8/533 (1.50%)  4/535 (0.75%) 
Infections and infestations     
Urinary tract infection  1  6/533 (1.13%)  7/535 (1.31%) 
Investigations     
Alanine aminotransferase increased  1  9/533 (1.69%)  5/535 (0.93%) 
Aspartate aminotransferase increased  1  9/533 (1.69%)  5/535 (0.93%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/533 (0.19%)  6/535 (1.12%) 
Myalgia  1  6/533 (1.13%)  4/535 (0.75%) 
Nervous system disorders     
Dizziness  1  6/533 (1.13%)  1/535 (0.19%) 
Headache  1  31/533 (5.82%)  26/535 (4.86%) 
Psychiatric disorders     
Insomnia  1  7/533 (1.31%)  14/535 (2.62%) 
Vascular disorders     
Hypertension  1  16/533 (3.00%)  7/535 (1.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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.
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 investigator(s) must undertake not to submit any part of the data from this protocol for publication without the prior consent of Cubist Pharmaceuticals, Inc.
Results Point of Contact
Name/Title: Dr. Obi Umeh, Vice President Global Medical Sciences
Organization: Cubist Pharmaceuticals, Inc.
Phone: 781-860-8415
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: October 25, 2018