Safety and Efficacy of Ceftolozane/Tazobactam - ASPECT
Research type
Research Study
Full title
A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/tazobactam Compared With Meropenem in Adult Patients with Ventilated Nosocomial Pneumonia
IRAS ID
160772
Contact name
Bryan Carr
Contact email
Sponsor organisation
Cubist Pharmaceuticals, Inc.
Eudract number
2012-002862-11
Duration of Study in the UK
2 years, 7 months, 4 days
Research summary
This clinical trial is to find out whether Ceftolozane/Tazobactam is as good as Meropenem to treat patients suffering from Ventilated Nosocomial Pneumonia (VNP).
Nosocomial Pneumonia (NP) is a type of lung infection that may be caused by being on a ventilator, or may result in patients’ being put on a ventilator. The purpose of this research study is to learn if the investigational drug Ceftolozane/Tazobactam can treat the VNP patients safely and effectively, compared to Meropenem (an approved antibiotic commonly used to treat this condition).
To compare two drugs, the participants will receive either Ceftolozane/Tazobactam 3000mg (comprising 2000 mg ceftolozane and 1000 mg tazobactam), or Meropenem 1000 mg by same chance and no one will know which medication the participants are taking. Additionally they may receive another approved antibiotic called Linezolid if their lung infection is caused by a certain type of bacteria that cannot be treated by either of the study medications.
During the treatment period, the participants will receive the study medication through intravenous infusion for 1 hour, every 8 hours for 8 days. They should be hospitalised throughout the treatment period. The end-of-therapy (EOT) visit is planned within 24 hours after the last study medication infusion to check the participants’ safety and effectiveness of the study medication. Further check-ups will be performed twice after the EOT visit. The participants are expected to take part in this study for up to 51 days.
Microbiology assessments such as lower respiratory tract (LRT) culture will be performed during the study to see how the VNP respond to the study medication depend on the causes of the infection. The result will demonstrate which bacteria is the main cause of the participant’s VNP, and it can be used to explain why some participants’ VNP is getting better more quickly than others’.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0481
Date of REC Opinion
27 Jul 2015
REC opinion
Further Information Favourable Opinion