Multi-centre study of the in vitro activity of ceftolozane/tazobactam and other commonly used antibiotics against Pseudomonas aeruginosa isolates from patients in the United Kingdom (INVICTUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23452
• EU PAS number:
  EUPAS23451
• Study ID:
  23452
• Official title and acronym:
  Multi-centre study of the in vitro activity of ceftolozane/tazobactam and other commonly used antibiotics against Pseudomonas aeruginosa isolates from patients in the United Kingdom (INVICTUS)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Participating centre will be asked to test a minimum of 50 consecutive clinically significant isolates of P. aeruginosa bacteria. Centres are requested to provide basic background information on the sample and the isolates. All study analysis (re-identification of P. aeruginosa isolates by laboratory testing) and data collection will be performed locally at each participant centre. St. Georges Hospital, London, will act as the designated Central Testing Laboratory where all study isolates will be storage. Additionally, the Central Testing Laboratory will carry out quality control assays in a selected number of isolates per centre. Overall, up to 30% of the isolates included in the study will have been isolated from cystic fibrosis patients.
• Study status:
  Ongoing

Research institution and networks

Institutions

St George's University of London

Department of Medical Microbiology

Royal Devon and Exeter NHS Foundation Trust

Southmead Hospital

Royal Devon and Exeter Hospital Exeter, Freeman Hospital Newcastle, Heart of England Hospital Birmingham, Lewsisham University Hospital and Queen Elizabeth Hospital Lewisham, Pennine Acute Trust Manchester, Barts Health (Royal London & St Bartholamews Hospitals) London, Nottingham (Queen’s Medical Centre) Nottingham, Queen Alexandra Hospital - Cosham Portsmouth, Broomfield Hospital Broomfield, Southmead Hospital Bristol

Study timelines

Date when funding contract was signed

Planned: 08/03/2018

Actual: 08/03/2018

Study start date

Planned: 09/03/2018

Actual: 09/03/2018

Date of final study report

Planned: 01/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharpe and Dohme Ltd

Study protocol

Initial protocol

In vitro activity of CT and other antibiotics against P. aeruginosa in the UK FINAL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

IRAS Project ID: 241580