Use of sulfonamide-trimethoprim combinations during pregnancy in IMRD-Germany and IMRD-France

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40520
• EU PAS number:
  EUPAS40519
• Study ID:
  40520
• Official title and acronym:
  Use of sulfonamide-trimethoprim combinations during pregnancy in IMRD-Germany and IMRD-France
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany
• Study description:
  The aim of this study was to determine the extent of use of sulfonamide and trimethoprim combination products during pregnancy. Use of sulfonamide and trimethoprim combination products was compared to alternative antibiotics: fosfomycin, plain amoxicillin and amoxicillin in combination with clavulanic acid. The type of infection was classified based on recorded ICD codes.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 05/11/2019

Actual: 05/11/2019

Study start date

Planned: 05/11/2019

Actual: 05/11/2019

Date of final study report

Planned: 26/11/2019

Actual: 26/11/2019

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable