---
title: Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
nct_id: NCT01853982
overall_status: TERMINATED
phase: PHASE3
sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
study_type: INTERVENTIONAL
primary_condition: Ventilator-Associated Pneumonia (VAP)
countries: United States, Australia, New Zealand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01853982.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01853982"
ct_last_update_post_date: 2018-11-16
last_seen_at: "2026-05-12T06:56:45.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

**Official Title:** A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam With That of Piperacillin/Tazobactam in Ventilator Associated Pneumonia

**NCT ID:** [NCT01853982](https://clinicaltrials.gov/study/NCT01853982)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Terminated to focus on a larger study within the clinical development program.
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 4
- **Lead Sponsor:** Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- **Conditions:** Ventilator-Associated Pneumonia (VAP)
- **Start Date:** 2013-06-14
- **Completion Date:** 2013-12-08
- **CT.gov Last Update:** 2018-11-16

## 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 .

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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

## Interventions

- **Ceftolozane/Tazobactam** (DRUG)
- **Piperacillin/Tazobactam** (DRUG)

## Primary Outcomes

- **Clinical Response at the End of Therapy Visit** _(time frame: 24 hours after last dose of study drug)_

## Locations (19)

- Jacksonville, Florida, United States
- 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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|jacksonville|florida|united states` — added _(2026-05-12)_
- `locations.|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.|baltimore|maryland|united states` — added _(2026-05-12)_
- `locations.|duluth|minnesota|united states` — added _(2026-05-12)_
- `locations.|omaha|nebraska|united states` — added _(2026-05-12)_
- `locations.|jamaica|new york|united states` — added _(2026-05-12)_
- `locations.|the bronx|new york|united states` — added _(2026-05-12)_
- `locations.|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.|oklahoma city|oklahoma|united states` — added _(2026-05-12)_
- `locations.|abington|pennsylvania|united states` — added _(2026-05-12)_
- `locations.|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.|herston|queensland|australia` — added _(2026-05-12)_
- `locations.|meadowbrook|queensland|australia` — added _(2026-05-12)_
- `locations.|nambour|queensland|australia` — added _(2026-05-12)_
- `locations.|southport|queensland|australia` — added _(2026-05-12)_
- `locations.|woolloongabba|queensland|australia` — added _(2026-05-12)_
- `locations.|auckland||new zealand` — added _(2026-05-12)_
- `locations.|christchurch||new zealand` — added _(2026-05-12)_
- `locations.|wellington||new zealand` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01853982.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01853982*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*