Trial Outcomes & Findings for Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections (NCT NCT00921024)
NCT ID: NCT00921024
Last Updated: 2018-10-18
Results Overview
Microbiological response is eradication for each baseline pathogen
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
TOC; 6-9 days after last study drug administration
Results posted on
2018-10-18
Participant Flow
Two subjects, one in each arm, did not receive treatment.
Participant milestones
| Measure |
CXA-101
CXA-101: intravenous 1000 mg every 8 hours
|
Ceftazidime
Ceftazidime: intravenous 1000 mg every 8 hours
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
42
|
|
Overall Study
COMPLETED
|
81
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
CXA-101
CXA-101: intravenous 1000 mg every 8 hours
|
Ceftazidime
Ceftazidime: intravenous 1000 mg every 8 hours
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Received concomittant therapy
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
Baseline characteristics by cohort
| Measure |
CXA-101
n=85 Participants
CXA-101: intravenous 1000 mg every 8 hours
|
Ceftazidime
n=42 Participants
Ceftazidime: intravenous 1000 mg every 8 hours
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 19.78 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 19.74 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 19.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TOC; 6-9 days after last study drug administrationPopulation: mMITT: Treated patients, with baseline pathogen.
Microbiological response is eradication for each baseline pathogen
Outcome measures
| Measure |
CXA-101
n=65 Participants
CXA-101: intravenous 1000 mg every 8 hours
|
Ceftazidime
n=38 Participants
Ceftazidime: intravenous 1000 mg every 8 hours
|
|---|---|---|
|
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
|
83.1 percentage of patients
Interval 71.7 to 91.2
|
76.3 percentage of patients
Interval 59.8 to 88.6
|
PRIMARY outcome
Timeframe: TOC; 6-9 days after last study drug administrationPopulation: ME: Treated patients, with baseline pathogen, complied with protocol.
Microbiological response is eradication for each baseline pathogen
Outcome measures
| Measure |
CXA-101
n=55 Participants
CXA-101: intravenous 1000 mg every 8 hours
|
Ceftazidime
n=27 Participants
Ceftazidime: intravenous 1000 mg every 8 hours
|
|---|---|---|
|
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
|
85.5 percentage of patients
Interval 73.3 to 93.5
|
92.6 percentage of patients
Interval 75.7 to 99.1
|
Adverse Events
CXA-101
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Ceftazidime
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CXA-101
n=85 participants at risk
CXA-101: intravenous 1000 mg every 8 hours
|
Ceftazidime
n=42 participants at risk
Ceftazidime: intravenous 1000 mg every 8 hours
|
|---|---|---|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/85 • Number of events 1
|
0.00%
0/42
|
Other adverse events
| Measure |
CXA-101
n=85 participants at risk
CXA-101: intravenous 1000 mg every 8 hours
|
Ceftazidime
n=42 participants at risk
Ceftazidime: intravenous 1000 mg every 8 hours
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/85
|
2.4%
1/42
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/85
|
2.4%
1/42
|
|
Eye disorders
Arteriosclerotic retinopathy
|
0.00%
0/85
|
2.4%
1/42
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/85
|
2.4%
1/42
|
|
Eye disorders
Vision blurred
|
0.00%
0/85
|
2.4%
1/42
|
|
Eye disorders
Visual impairment
|
0.00%
0/85
|
2.4%
1/42
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
2/85
|
2.4%
1/42
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/85
|
2.4%
1/42
|
|
Gastrointestinal disorders
Constipation
|
9.4%
8/85
|
4.8%
2/42
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
3/85
|
7.1%
3/42
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/85
|
2.4%
1/42
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/85
|
2.4%
1/42
|
|
Gastrointestinal disorders
Nausea
|
5.9%
5/85
|
0.00%
0/42
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/85
|
2.4%
1/42
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/85
|
2.4%
1/42
|
|
General disorders
Chest pain
|
0.00%
0/85
|
2.4%
1/42
|
|
General disorders
Chills
|
0.00%
0/85
|
2.4%
1/42
|
|
General disorders
Feeling abnormal
|
0.00%
0/85
|
2.4%
1/42
|
|
General disorders
Infusion site erythema
|
2.4%
2/85
|
0.00%
0/42
|
|
General disorders
Infusion site extravasation
|
2.4%
2/85
|
0.00%
0/42
|
|
General disorders
Infustion site irritation
|
3.5%
3/85
|
0.00%
0/42
|
|
General disorders
Infusion site reaction
|
1.2%
1/85
|
2.4%
1/42
|
|
General disorders
Infustion site swelling
|
2.4%
2/85
|
0.00%
0/42
|
|
General disorders
Pyrexia
|
3.5%
3/85
|
2.4%
1/42
|
|
Infections and infestations
Urinary tract infection
|
2.4%
2/85
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/85
|
2.4%
1/42
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/85
|
2.4%
1/42
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.4%
2/85
|
0.00%
0/42
|
|
Nervous system disorders
Headache
|
5.9%
5/85
|
0.00%
0/42
|
|
Psychiatric disorders
Agression
|
0.00%
0/85
|
2.4%
1/42
|
|
Psychiatric disorders
Depression
|
0.00%
0/85
|
2.4%
1/42
|
|
Psychiatric disorders
Insomnia
|
4.7%
4/85
|
0.00%
0/42
|
|
Psychiatric disorders
Sleep disorder
|
7.1%
6/85
|
4.8%
2/42
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/85
|
2.4%
1/42
|
|
Renal and urinary disorders
Renal cyst
|
1.2%
1/85
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
2/85
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/85
|
2.4%
1/42
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.2%
1/85
|
2.4%
1/42
|
|
Vascular disorders
Hypertension
|
2.4%
2/85
|
0.00%
0/42
|
|
Vascular disorders
Hypotension
|
1.2%
1/85
|
2.4%
1/42
|
|
Vascular disorders
Phlebitis
|
2.4%
2/85
|
0.00%
0/42
|
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 data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Authorship on any primary publication of the results from this study will be based on contributions to study design, enrollment, data analysis, and interpretation of results.
- Publication restrictions are in place
Restriction type: OTHER