Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CXA-NP-11-08 | Other Identifier | Cubist Study Number |
Not provided
Not provided
Not provided
Terminated to focus on a larger study within the clinical development program.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftolozane/Tazobactam | Experimental | 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 | Active Comparator | 4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftolozane/Tazobactam | Drug |
| ||
| Piperacillin/Tazobactam |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at the End of Therapy Visit | 24 hours after last dose of study drug |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Obiamiwe Umeh, MD | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | United States | ||||
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Piperacillin/Tazobactam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Chicago |
| Illinois |
| United States |
| Baltimore | Maryland | United States |
| Duluth | Minnesota | United States |
| Omaha | Nebraska | United States |
| Jamaica | New York | United States |
| The Bronx | New York | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Abington | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Herston | Queensland | Australia |
| Meadowbrook | Queensland | Australia |
| Nambour | Queensland | Australia |
| Southport | Queensland | Australia |
| Woolloongabba | Queensland | Australia |
| Auckland | New Zealand |
| Christchurch | New Zealand |
| Wellington | New Zealand |
4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ceftolozane/Tazobactam | 3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days |
| BG001 | Piperacillin/Tazobactam | 4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Response at the End of Therapy Visit | 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. | Posted | 24 hours after last dose of study drug |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceftolozane/Tazobactam | 3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days | 1 | 2 | 2 | 2 | ||
| EG001 | Piperacillin/Tazobactam | 4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days | 1 | 2 | 1 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| CNS ventriculitis | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research | Cubist Pharmaceuticals, Inc. | 1.781.860.8660 |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594038 | ceftolozane, tazobactam drug combination |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| GTE65 |
|
| Male |
|