Trial Outcomes & Findings for Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia (NCT NCT01853982)
NCT ID: NCT01853982
Last Updated: 2018-11-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
24 hours after last dose of study drug
Results posted on
2018-11-16
Participant Flow
On 31 Dec 2013, enrollment was closed and the CXA-NP-11-08 study was electively terminated by the Sponsor in order to devote all resources in initiating and completing the larger registrational study (CXA-NP-11-04), which was also being conducted as part of the clinical development program for nosocomial pneumonia.
Participant milestones
| Measure |
Ceftolozane/Tazobactam
3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
|
Piperacillin/Tazobactam
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ceftolozane/Tazobactam
3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
|
Piperacillin/Tazobactam
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
Baseline characteristics by cohort
| Measure |
Ceftolozane/Tazobactam
n=2 Participants
3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
|
Piperacillin/Tazobactam
n=2 Participants
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
LTE18
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
BTWN
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Categorical
GTE65
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hours after last dose of study drugPopulation: There is no analysis population or data available for this measure. This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.
Outcome measures
Outcome data not reported
Adverse Events
Ceftolozane/Tazobactam
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Piperacillin/Tazobactam
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ceftolozane/Tazobactam
n=2 participants at risk
3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
|
Piperacillin/Tazobactam
n=2 participants at risk
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal ischaemia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
General disorders
General physical health deterioration
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
CNS ventriculitis
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
Other adverse events
| Measure |
Ceftolozane/Tazobactam
n=2 participants at risk
3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
|
Piperacillin/Tazobactam
n=2 participants at risk
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals, Inc.
Phone: 1.781.860.8660
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER