A retrospective study on patients infected with CarbNS-GN
Research type
Research Study
Full title
A retrospective study to evaluate the epidemiology, standard of care, outcomes and resource use associated with patients who have, or are at risk of, infection with carbapenem non-susceptible gram-negative organisms of interest (Enterobacteriacae, Pseudomonas, Stenotrophomonas and Acinetobacter)
IRAS ID
245321
Contact name
Simon Goldenberg
Contact email
Sponsor organisation
Shionogi Limited
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
This is a retrospective study to be conducted in patients who have, or are at risk of, infection with carbapenem non-susceptible gram-negative organisms of interest (CarbNS-GN).
This retrospective chart review study of existing medical records has two parts:
Part 1 – Epidemiological overview: microbiology results will be collected for all patients (including children) who were tested for gram-negative (GN) infections between 01 April 2017 and 31 March 2018 at each study site.
Part 2 – Retrospective chart review: retrospective data will be collected on hospitalised adult patients who had confirmed CarbNS-GN infection and had been treated for CarbNS-GN between 01 April 2017 and 31 March 2018 at each study site. Patients will be followed from the index date (the date of the first positive sample for CarbNS-GN) for up to 3 months or until discharge from hospital (if earlier).
The study will take place in 10 centres. It is expected to recruit all patients meeting the inclusion criteria in each centre for Part 1 and approximately 200 patients for Part 2 in the UK.REC name
East of Scotland Research Ethics Service REC 1
REC reference
18/ES/0066
Date of REC Opinion
4 Jun 2018
REC opinion
Further Information Favourable Opinion