Trial · NCT02070757
Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)
NCT02070757, Phase 3, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2019-05-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008). Trials, record NCT02070757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02070757
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)
- NCT number
- NCT02070757
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 726 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Healthcare-Associated Pneumonia, Ventilator-Associated Pneumonia, Lung Diseases
- Interventions
- Ceftolozane/tazobactam, Meropenem
- First posted
- 2014-02-25
- Last updated
- 2020-05-05
- Results first posted
- 2019-05-31
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28 | Day 28 | To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in stratified adult participants with ventilated nosocomial pneumonia (VNP) (participants with either ventilator-associated bacterial pneumonia \[VABP\] or ventilated hospital-acquired bacterial pneumonia \[HABP\]) based on the difference in all-cause mortality rates in the intent to treat (ITT) population using a non-inferiority margin of 10%. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights. |
| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population | 7 to 14 days after last dose of study drug (Up to ~Day 30) | To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) at the TOC visit (7 to 14 days after the end-of-therapy \[EOT\] visit) using a non-inferiority margin of 12.5%. Clinical response at the TOC visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate unless the clinical outcome at the EOT visit was failure. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights. |
| Secondary | Percentage of Participants With All Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population - Day 28 | Day 28 | To compare the all cause mortality rates of participants in the ceftolozane/tazobactam versus meropenem arms in microbiological intent-to-treat (mITT) population. |
| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population | 7 to 14 days after last dose of study drug (Up to ~Day 30) | To compare the clinical response rates of ceftolozane/tazobactam versus meropenem in adult participants with VNP (participants with either ventilator-associated bacterial pneumonia \[VABP\] or ventilated hospital-acquired bacterial pneumonia \[HABP\]) at the TOC visit in the CE population. Clinical response at the TOC visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate unless the clinical outcome at the EOT visit was failure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population. |
| Secondary | Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population | 7 to 14 days after last dose of study drug (Up to ~Day 30) | To compare the per-participant microbiological response rates of ceftolozane/tazobactam versus meropenem at the TOC visit in the microbiologically evaluable (ME) population. The per-participant microbiological response will be determined based on the individual microbiological outcomes for each baseline pathogen. A microbiological response at the TOC visit was defined as cure (baseline pathogens eradicated), failure (baseline pathogen is persistent) or indeterminate (no evaluable respiratory material). A favorable microbiological response is a microbiological cure or presumed cure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population. |
| Secondary | Percentage of Participants With Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population (>=10 Isolates at Baseline) | 7 to 14 days after last dose of study drug (Up to ~Day 30) | To compare the percentage of participants with a microbiological outcome of eradication or presumed eradication, by pathogen. The microbiological outcome was classified as "eradication", "presumed eradication", "persistence", 'presumed persistence", "indeterminate" or "recurrence." "Eradication" was defined as a ≥1- log reduction in bacterial burden of the original baseline LRT pathogen AND a per pathogen count of ≤10\^4 colony-forming unit (CFU)/mL for endotracheal aspirate (ETA) or sputum specimens, ≤10\^3 CFU/mL for a bronchoalveolar lavage (BAL) specimen, or ≤10\^2 CFU/mL for a protected brush specimen (PBS) from a follow-up LRT culture. Presumed eradication was defined as an absence of material to culture (e.g. inability to obtain a culture in an extubated patient) in a patient deemed a clinical cure. |
| Secondary | Percentage of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population - Day 14 | Day 14 | To compare the all cause mortality rates of participants (ceftolozane/tazobactam versus meropenem arms). Participants whose Day 14 mortality outcomes are missing or unknown are analysed as deceased. |
| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population | Within 24 hours after last dose of study drug (Up to ~Day 15) | To compare the clinical response rates at the EOT visit for ceftolozane/tazobactam versus meropenem. Clinical response at the EOT visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate. |
| Secondary | Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the End-of-Therapy (EOT) Visit in the Microbiologically Evaluable (ME) Population | Within 24 hours after last dose of study drug (Up to ~Day 15) | To compare the microbiological response rates of ceftolozane/tazobactam versus meropenem at the EOT visit. The per-participant microbiological response will be determined based on the individual microbiological outcomes for each baseline pathogen. A microbiological response at the EOT visit was defined as cure (baseline pathogens eradicated), failure (baseline pathogen is persistent) or indeterminate (no evaluable respiratory material). A favorable microbiological response is a microbiological cure or presumed cure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population. |
| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at the Late Follow-up (LFU) Visit in the Clinically Evaluable (CE) Population | 28 to 35 days after the last dose of study drug (Up to ~Day 50) | To compare the clinical response rates at the Late Follow-up (LFU) visit for ceftolozane/tazobactam versus meropenem in the CE population. Clinical response at the LFU visit will be classified as sustained cure, relapse, or indeterminate only in participants deemed a clinical cure at the TOC visit. A favorable clinical response is "sustained clinical cure." |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28 | Day 28 | The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population | 7 to 14 days after last dose of study drug (Up to ~Day 30) | The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With All Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population - Day 28 | Day 28 | The mITT population was a subset of the ITT population that included any participant who received any amount of study drug and had at least 1 bacterial respiratory pathogen isolated from the baseline LRT culture that was susceptible to at least 1 of the study drugs. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population | 7 to 14 days after last dose of study drug (Up to ~Day 30) | The CE population was a subset of the ITT population that included any participant who received study drug, adhered to the study protocol through the TOC visit, and had an evaluable clinical outcome (either Cure or Failure) at the TOC visit (or were classified as a clinical failure prior to the TOC visit). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population | 7 to 14 days after last dose of study drug (Up to ~Day 30) | The ME population was a subset of the mITT population that included any participants who adhered to the study protocol through the TOC visit, had an evaluable clinical outcome (Cure or Failure) at the TOC visit and had at least 1 bacterial respiratory pathogen (at the appropriate CFU/mL threshold) isolated from the baseline LRT culture. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population (>=10 Isolates at Baseline) | 7 to 14 days after last dose of study drug (Up to ~Day 30) | The ME population included any participants in the mITT who adhered to the protocol, had an evaluable clinical outcome at TOC and at least 1 pathogen isolated from the baseline LRT culture at the appropriate CFU/mL threshold. The number analyzed per pathogen represents the number of participants in the ME population with that specific pathogen. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population - Day 14 | Day 14 | The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population | Within 24 hours after last dose of study drug (Up to ~Day 15) | The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the End-of-Therapy (EOT) Visit in the Microbiologically Evaluable (ME) Population | Within 24 hours after last dose of study drug (Up to ~Day 15) | The ME population was a subset of the mITT population that included any participants who adhered to the study protocol through the TOC visit, had an evaluable clinical outcome (Cure or Failure) at the TOC visit and had at least 1 bacterial respiratory pathogen (at the appropriate CFU/mL threshold) isolated from the baseline LRT culture. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Clinical Cure at the Late Follow-up (LFU) Visit in the Clinically Evaluable (CE) Population | 28 to 35 days after the last dose of study drug (Up to ~Day 50) | The CE population was a subset of the ITT population that included any participant who received study drug, adhered to the study protocol through the TOC visit, and had an evaluable clinical outcome (either Cure or Failure) at the TOC visit (or were classified as a clinical failure prior to the TOC visit). | Percentage of Participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28 | Ceftolozane/Tazobactam | 24.0 | 95% Confidence Interval 18.83 to 27.39 | Percentage of Participants | |
| Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28 | Meropenem | 25.3 | 95% Confidence Interval 19.96 to 28.41 | Percentage of Participants | |
| Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population | Ceftolozane/Tazobactam | 54.4 | 95% Confidence Interval 49.47 to 59.60 | Percentage of Participants | |
| Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population | Meropenem | 53.3 | 95% Confidence Interval 48.44 to 58.54 | Percentage of Participants | |
| Percentage of Participants With All Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population - Day 28 | Ceftolozane/Tazobactam | 20.1 | 95% Confidence Interval 15.12 to 24.50 | Percentage of Participants | |
| Percentage of Participants With All Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population - Day 28 | Meropenem | 25.5 | 95% Confidence Interval 18.89 to 29.35 | Percentage of Participants | |
| Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population | Ceftolozane/Tazobactam | 63.8 | 95% Confidence Interval 57.50 to 70.11 | Percentage of Participants | |
| Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population | Meropenem | 64.7 | 95% Confidence Interval 58.83 to 71.19 | Percentage of Participants | |
| Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population | Ceftolozane/Tazobactam | 70.4 | 95% Confidence Interval 61.37 to 77.55 | Percentage of Participants | |
| Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population | Meropenem | 62.7 | 95% Confidence Interval 54.12 to 71.24 | Percentage of Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftolozane/Tazobactam | 362 | |
| Overall Study | STARTED | Meropenem | 364 | |
| Overall Study | Treated Participants | Ceftolozane/Tazobactam | 361 | |
| Overall Study | Treated Participants | Meropenem | 359 | |
| Overall Study | COMPLETED | Ceftolozane/Tazobactam | 245 | |
| Overall Study | COMPLETED | Meropenem | 250 | |
| Overall Study | NOT COMPLETED | Ceftolozane/Tazobactam | 117 | |
| Overall Study | NOT COMPLETED | Meropenem | 114 |
Source ClinicalTrials.gov
Adverse events318
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ceftolozane/Tazobactam | 32 | 361 | 32 |
| other | Anaemia | Blood and lymphatic system disorders | Meropenem | 38 | 359 | 45 |
| other | Diarrhoea | Gastrointestinal disorders | Ceftolozane/Tazobactam | 23 | 361 | 23 |
| other | Diarrhoea | Gastrointestinal disorders | Meropenem | 25 | 359 | 28 |
| other | Urinary tract infection | Infections and infestations | Ceftolozane/Tazobactam | 23 | 361 | 24 |
| other | Urinary tract infection | Infections and infestations | Meropenem | 25 | 359 | 27 |
| other | Alanine aminotransferase increased | Investigations | Ceftolozane/Tazobactam | 20 | 361 | 21 |
| other | Alanine aminotransferase increased | Investigations | Meropenem | 14 | 359 | 14 |
| other | Hydrothorax | Respiratory, thoracic and mediastinal disorders | Ceftolozane/Tazobactam | 16 | 361 | 17 |
| other | Hydrothorax | Respiratory, thoracic and mediastinal disorders | Meropenem | 20 | 359 | 24 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ceftolozane/Tazobactam | 105 | 361 |
| Total, all-cause mortality | Meropenem | 101 | 359 |
| Total, other adverse events | Ceftolozane/Tazobactam | 113 | 361 |
| Total, other adverse events | Meropenem | 111 | 359 |
| Total, serious adverse events | Ceftolozane/Tazobactam | 152 | 361 |
| Total, serious adverse events | Meropenem | 129 | 359 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ceftolozane/Tazobactam vs Meropenem: deaths from any cause | Trial comparisons |
| Ceftolozane/Tazobactam vs Meropenem: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02070757/results?page=2