Spectra Retrospective Chart Review
Research type
Research Study
Full title
Study of Prescribing patterns and Effectiveness of Ceftolozane Tazobactam: Real-world Analysis (SPECTRA)
IRAS ID
232458
Contact name
Sunny Kaul
Contact email
Sponsor organisation
Dohme Corp., a subsidiary of Merck & Co., Inc.
Clinicaltrials.gov Identifier
Product MK-7625A, Sponsors compound number; 4549, VEAP ID NO
Duration of Study in the UK
1 years, 0 months, 17 days
Research summary
Zerbaxa™ (ceftolozane/tazobactam) is a combination product consisting of a cephalosporin-class antibacterial drug and a beta-lactamase inhibitor indicated for the treatment of the following infections caused by designated susceptible microorganisms:
Complicated intra-abdominal infection (cIAI), used in combination with metronidazole
Complicated urinary tract infection (cUTI), including pyelonephritis
Zerbaxa has been approved in many countries worldwide including the United States in 2014 and the European Union and Australia in 2015. Ceftolozane/tazobactam was evaluated in two Phase 3 comparator-controlled clinical trials, ASPECT-cIAI and ASPECT-cUTI.
The aim of this study is to complement previous and ongoing clinical trials with this drug, adding to the body of evidence to provide physicians, hospitals, and other stakeholders with real-world evidence to better inform clinical practice and maximize use of financial resources. Therefore, the SPECTRA Study is being conducted to describe sociodemographic and clinical characteristics, treatment patterns, and outcomes in hospitalized patients treated with ceftolozane/tazobactam.
The primary objectives are to evaluate Zerbaxa’s use including dose, duration, time to therapy, combination therapy, pathogen, source, susceptibility, patient and clinical factors associated with the use outside of a clinical trial setting. In addition, clinical and economic outcomes will be described for this population. It is expected that ceftolozane/tazobactam will provide a successful treatment option for patients in a clinical setting.This is a multinational, multicentre, observational retrospective data collection study. Data will be collected from medical charts for hospitalised patients treated with Zerbaxa in a hospital setting for a minimum of 48 hours.
Coded data from hospital charts will be abstracted to describe sociodemographic and clinical characteristics, treatment patterns, outcomes and resource utilization.As an observational study, this study is not intended to change the patient/physician relationship, nor influence the physician’s drug prescription or therapeutic management of the patient.
Research Summary
Gram negative (GN) bacteria, in particular Pseudomonas aeruginosa and the Enterobacterales, exhibit multiple mechanisms of antibiotic resistance. These pathogens therefore represent a serious global public health concern.
Zerbaxa™ (ceftolozane/tazobactam [C/T]) is a combination product consisting of a cephalosporinclass antibacterial drug and a beta-lactamase inhibitor indicated for the treatment of the following infections caused by designated susceptible microorganisms: hospital-acquired bacteria pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), complicated intraabdominal infection (cIAI), used in combination with metronidazole, complicated urinary tract infection (cUTI), including pyelonephritis.
The primary objective of the study was to describe the real-world utilization of C/T: sociodemographic, clinical characteristics, treatment patterns, clinical outcomes and resource utilization in hospitalized patients who received treatment with C/T. The secondary objective of the study was to describe differences in clinical success, treatment duration, microbiological (MB) eradication by empiric versus definitive treatment, severity of the illness, sole versus combination C/T therapy, initial versus salvage C/T therapy and indication.
This was an international, multicenter retrospective chart review study, designed to collect clinical and resource utilization data on patients who were treated with a minimum of 48 hours of C/T in a hospital setting. As an observational, retrospective study, this study had no influence over the patient-physician relationship or treatment management of the patient.
Findings from SPECTRA confirm real-world effectiveness and safety of C/T in a wide variety of patients including in patients with complicated GN infections and serious illness. Future studies are needed to further analyze outcomes associated with C/T use in patients with drug-resistant GN pathogens.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/2003
Date of REC Opinion
17 Nov 2017
REC opinion
Favourable Opinion