Indications for systemic fluoroquinolone prescribing in Europe: a descriptive population based study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25386
• EU PAS number:
  EUPAS20889
• Study ID:
  25386
• Official title and acronym:
  Indications for systemic fluoroquinolone prescribing in Europe: a descriptive population based study
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  A descriptive analysis of indications for treatment with systemic fluoroquinolone antibiotics in Summary of Product Characteristics across the European Economic Area (EEA) will first be conducted. Secondly a descriptive analysis of clinical indications for treatment with systemic fluoroquinolone antibiotics in France, Germany and UK will be conducted using electronic health records. Time trends in fluoroquinolone antibiotic use will be evaluated. Indications for acute sinusitis, acute bronchitis and uncomplicated urinary tract infection will specifically be evaluated.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 10/10/2016

Actual: 10/10/2016

Study start date

Planned: 17/10/2016

Actual: 17/10/2016

Data analysis start date

Planned: 14/11/2016

Actual: 14/11/2016

Date of final study report

Planned: 13/11/2017

Actual: 06/08/2018

Sources of funding

EMA

Study protocol

Initial protocol

EUPAS20889.protocol

Regulatory

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