Retrospective chart review study of cefiderocol real world outcomes and safety in the treatment of patients with Gram-negative bacterial infections (GNBI) in the US and Europe (PROVE)

Study identification

• EU PAS number:
  EUPAS40551
• Study ID:
  41381
• Official title and acronym:
  Retrospective chart review study of cefiderocol real world outcomes and safety in the treatment of patients with Gram-negative bacterial infections (GNBI) in the US and Europe (PROVE)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom

  United States
• Study description:
  Characterize the use of cefiderocol in the treatment of Gram-negative bacterial infections (GNBI) by describing the patients that have been prescribed this antibiotic as well as the hospital course of such patients. This will include risk factors for carbapenem resistant disease, baseline comorbidities, and the pattern of other antibiotics used for the same infection. Outcomes such as inpatient mortality, safety events, and length of stay will be assessed.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Shionogi

Shionogi BV (SBV), Hoburn, UK Shionogi, Inc. Florham Park, NJ, USA

Study timelines

Date when funding contract was signed

Planned:01/04/2020

Actual:16/10/2020

Study start date

Planned:01/05/2021

Actual:29/04/2021

Data analysis start date

Planned:01/03/2023

Date of interim report, if expected

Planned:01/06/2021

Date of final study report

Planned:01/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Shionogi, Inc

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

Non-interventional study protocol 2020-266-1