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

Ventilator-Associated Pneumonia (VAP) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01853982
• Other study ID #: 7625A-009
• Secondary ID: CXA-NP-11-08
• Status: Terminated
• Phase: Phase 3
• Start date: June 14, 2013
• Est. completion date: December 8, 2013

Study information

• Verified date: October 2018
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 8, 2013
• Est. primary completion date: November 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-Associated Pneumonia (VAP)

Intervention

Drug:
• Ceftolozane/Tazobactam

• Piperacillin/Tazobactam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response at the End of Therapy Visit		24 hours after last dose of study drug