An observational multicenter study on antibiotic resistance of Helicobacter pylori in France (PHARE)

Study identification

• EU PAS number:
  EUPAS35756
• Study ID:
  35817
• Official title and acronym:
  An observational multicenter study on antibiotic resistance of Helicobacter pylori in France (PHARE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Observational multicenter study to be conducted in France, with subjects having scheduled one consultation with their gastroenterologist as part of their regular follow up for an endoscopy with biopsies (antral and fundic) to look for infection by Helicobacter pylori and to test the resistance of this bacterium to antibiotics. This study is non-interventional. It is conducted according to the usual medical practice in accordance with the current recommendations and does not impose additional diagnostic approaches or therapeutics strategies.
• Study status:
  Finalised

Research institutions and networks

Institutions

Umanis Clinical Research

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:01/08/2013

Actual:12/02/2013

Study start date

Planned:28/02/2014

Actual:24/02/2014

Data analysis start date

Planned:28/02/2015

Date of interim report, if expected

Planned:30/04/2015

Actual:19/06/2015

Date of final study report

Planned:30/09/2019

Actual:10/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aptalis

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

PYR-12-01