Trial Outcomes & Findings for Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis (NCT NCT01345929)
NCT ID: NCT01345929
Last Updated: 2018-10-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
558 participants
Primary outcome timeframe
Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)
Results posted on
2018-10-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
533
|
535
|
|
Overall Study
COMPLETED
|
512
|
516
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
|
Overall Study
Lost to Follow-up
|
9
|
9
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Didn't meet eligibility criteria
|
2
|
0
|
|
Overall Study
40,000 CFU/ML
|
1
|
0
|
|
Overall Study
Patient withdrawal
|
0
|
1
|
Baseline Characteristics
Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis
Baseline characteristics by cohort
| Measure |
CXA-201 as Treatment for cUTI
n=533 Participants
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
n=535 Participants
Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days
|
Total
n=1068 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 19.52 • n=5 Participants
|
48.6 years
STANDARD_DEVIATION 20.05 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 19.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
374 Participants
n=5 Participants
|
380 Participants
n=7 Participants
|
754 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
159 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)Population: mMITT: Treated subjects, with baseline pathogen.
Outcome measures
| Measure |
CXA-201 as Treatment for cUTI
n=398 Participants
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
n=402 Participants
Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days
|
|---|---|---|
|
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
|
76.9 percentage of subjects
|
68.4 percentage of subjects
|
SECONDARY outcome
Timeframe: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)Population: ME: Treated patients, with baseline pathogen, complied with protocol.
Outcome measures
| Measure |
CXA-201 as Treatment for cUTI
n=341 Participants
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
n=353 Participants
Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days
|
|---|---|---|
|
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.
|
83.3 percentage of subjects
|
75.4 percentage of subjects
|
Adverse Events
CXA-201 as Treatment for cUTI
Serious events: 15 serious events
Other events: 108 other events
Deaths: 0 deaths
Levofloxacin as Treatment for cUTI
Serious events: 18 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CXA-201 as Treatment for cUTI
n=533 participants at risk
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
n=535 participants at risk
Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.56%
3/533
|
0.37%
2/535
|
|
Infections and infestations
Pneumonia
|
0.38%
2/533
|
0.00%
0/535
|
|
Infections and infestations
Urosepsis
|
0.38%
2/533
|
0.00%
0/535
|
|
Infections and infestations
Abdominal abscess
|
0.19%
1/533
|
0.00%
0/535
|
|
Infections and infestations
Clostridium difficile colitis
|
0.19%
1/533
|
0.00%
0/535
|
|
Infections and infestations
Diverticulitis
|
0.19%
1/533
|
0.00%
0/535
|
|
Infections and infestations
Liver abscess
|
0.19%
1/533
|
0.00%
0/535
|
|
Infections and infestations
Pseudomembranous colitis
|
0.19%
1/533
|
0.00%
0/535
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/533
|
1.1%
6/535
|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.00%
0/533
|
0.19%
1/535
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/533
|
0.19%
1/535
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/533
|
0.19%
1/535
|
|
Infections and infestations
Sepsis
|
0.00%
0/533
|
0.19%
1/535
|
|
Renal and urinary disorders
Calculus urinary
|
0.19%
1/533
|
0.00%
0/535
|
|
Renal and urinary disorders
Renal colic
|
0.19%
1/533
|
0.00%
0/535
|
|
Renal and urinary disorders
Urinary retention
|
0.19%
1/533
|
0.00%
0/535
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.00%
0/533
|
0.19%
1/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.38%
2/533
|
0.00%
0/535
|
|
Eye disorders
Diabetic retinopaty
|
0.19%
1/533
|
0.00%
0/535
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/533
|
0.19%
1/535
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/533
|
0.19%
1/535
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/533
|
0.19%
1/535
|
|
General disorders
Hernia obstructive
|
0.00%
0/533
|
0.19%
1/535
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/533
|
0.19%
1/535
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/533
|
0.19%
1/535
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/533
|
0.19%
1/535
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/533
|
0.19%
1/535
|
Other adverse events
| Measure |
CXA-201 as Treatment for cUTI
n=533 participants at risk
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
n=535 participants at risk
Levofloxacin IV infusion (750mg qd) for 7 days
Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
7/533
|
1.1%
6/535
|
|
Gastrointestinal disorders
Constipation
|
3.9%
21/533
|
3.2%
17/535
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
10/533
|
4.3%
23/535
|
|
Gastrointestinal disorders
Nausea
|
2.8%
15/533
|
1.7%
9/535
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
6/533
|
1.1%
6/535
|
|
General disorders
Pyrexia
|
1.5%
8/533
|
0.75%
4/535
|
|
Infections and infestations
Urinary tract infection
|
1.1%
6/533
|
1.3%
7/535
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
9/533
|
0.93%
5/535
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
9/533
|
0.93%
5/535
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.19%
1/533
|
1.1%
6/535
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
6/533
|
0.75%
4/535
|
|
Nervous system disorders
Dizziness
|
1.1%
6/533
|
0.19%
1/535
|
|
Nervous system disorders
Headache
|
5.8%
31/533
|
4.9%
26/535
|
|
Psychiatric disorders
Insomnia
|
1.3%
7/533
|
2.6%
14/535
|
|
Vascular disorders
Hypertension
|
3.0%
16/533
|
1.3%
7/535
|
Additional Information
Dr. Obi Umeh, Vice President Global Medical Sciences
Cubist Pharmaceuticals, Inc.
Phone: 781-860-8415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER