NCT01853982

Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

Terminated Phase 3 Results posted Last updated 16 November 2018

What this trial tests

Phase 3 trial testing Ceftolozane/Tazobactam in Ventilator-Associated Pneumonia (VAP) in 4 participants. Terminated before completion.

Timeline

14 June 2013

Primary endpoint
20 November 2013

8 December 2013

Quick facts

Lead sponsor	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	14 June 2013
Primary completion	20 November 2013
Estimated completion	8 December 2013
Sites	19 locations across New Zealand, United States, Australia

Drugs / interventions tested

• Ceftolozane/Tazobactam
• Piperacillin/Tazobactam

Conditions studied

• Ventilator-Associated Pneumonia (VAP) — all drugs for Ventilator-Associated Pneumonia (VAP) →

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

18 and older, any sex, with Ventilator-Associated Pneumonia (VAP). Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ceftolozane/Tazobactam

Serious: 1/2 (50%)

Deaths: —

Piperacillin/Tazobactam

Serious: 1/2 (50%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Ceftolozane/Tazobactam	Piperacillin/Tazobactam
Intestinal ischaemia	Gastrointestinal disorders	—	—
General physical health deterioration	General disorders	—	—
CNS ventriculitis	Nervous system disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Ceftolozane/Tazobactam	Piperacillin/Tazobactam
Constipation	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Hypernatraemia	Metabolism and nutrition disorders	—	—
Anxiety	Psychiatric disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Intestinal ischaemia, General physical health deterioration, CNS ventriculitis.

Data from ClinicalTrials.gov NCT01853982 adverse events section.

Sponsor's own description

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 .

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multidrug-resistant and extensively drug-resistant Gram-negative pathogens: current and emerging therapeutic approaches.
   Karaiskos I, Giamarellou H. · · 2014 · cited 212× · PMID 24766095 · DOI 10.1517/14656566.2014.914172
2. New β-Lactamase Inhibitors in the Clinic.
   Papp-Wallace KM, Bonomo RA. · · 2016 · cited 121× · PMID 27208767 · DOI 10.1016/j.idc.2016.02.007