NCT01853982

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 .

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_3

Geographic Reach
3 countries

19 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

June 14, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2013

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 15, 2015

Completed
Last Updated

November 16, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

May 13, 2013

Results QC Date

April 19, 2015

Last Update Submit

October 18, 2018

Conditions

Ventilator-Associated Pneumonia (VAP)

Outcome Measures

Primary Outcomes (1)

  • Clinical Response at the End of Therapy Visit

    24 hours after last dose of study drug

Study Arms (2)

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

Drug: Ceftolozane/Tazobactam

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

Drug: Piperacillin/Tazobactam

Interventions

Ceftolozane/TazobactamDRUG
Ceftolozane/Tazobactam
Piperacillin/TazobactamDRUG
Also known as: Zosyn
Piperacillin/Tazobactam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
  • Known end stage renal disease or requirement for dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Duluth, Minnesota, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Jamaica, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Abington, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Herston, Queensland, Australia

Location

Unknown Facility

Meadowbrook, Queensland, Australia

Location

Unknown Facility

Nambour, Queensland, Australia

Location

Unknown Facility

Southport, Queensland, Australia

Location

Unknown Facility

Woolloongabba, Queensland, Australia

Location

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Christchurch, New Zealand

Location

Unknown Facility

Wellington, New Zealand

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

ceftolozane, tazobactam drug combinationPiperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.

Results Point of Contact

Title
Vice President, Clinical Research
Organization
Cubist Pharmaceuticals, Inc.
1.781.860.8660

Study Officials

  • Obiamiwe Umeh, MD

    Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 15, 2013

Study Start

June 14, 2013

Primary Completion

November 20, 2013

Study Completion

December 8, 2013

Last Updated

November 16, 2018

Results First Posted

June 15, 2015

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information

Locations

NZ(3)AU(5)US(11)