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

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

Status and phase: Terminated; Phase 3

Conditions: Ventilator-Associated Pneumonia (VAP)

Treatments: Drug: Piperacillin/Tazobactam; Drug: Ceftolozane/Tazobactam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01853982

7625A-009

CXA-NP-11-08 (Other Identifier)

Details and patient eligibility

About

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 .

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Ceftolozane/Tazobactam

Experimental group

Description:

3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days

Treatment:

Drug: Ceftolozane/Tazobactam

Piperacillin/Tazobactam

Active Comparator group

Description:

4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days

Treatment:

Drug: Piperacillin/Tazobactam