Ventilator-Associated Pneumonia (VAP)
Conditions
Brief summary
This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants .
Interventions
DRUGPiperacillin/Tazobactam
Sponsors
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participant has received mechanical ventilation for \> 48 hours * Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35 * Presence of a new or progressive infiltrate on chest x-ray * Presence of clinical criteria consistent with VAP Key
Exclusion criteria
* History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics * Known end stage renal disease or requirement for dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response at the End of Therapy Visit | 24 hours after last dose of study drug |
Countries
Australia, New Zealand, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Ceftolozane/Tazobactam 3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days | 2 |
| Piperacillin/Tazobactam 4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Ceftolozane/Tazobactam | Piperacillin/Tazobactam | Total |
|---|---|---|---|
| Age, Categorical BTWN | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical GTE65 | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical LTE18 | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 1 / 2 |
| serious Total, serious adverse events | 1 / 2 | 1 / 2 |
Outcome results
Primary
Clinical Response at the End of Therapy Visit
Time frame: 24 hours after last dose of study drug
Population: 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.