REACH study: Real-World Evidence study of OM-85 in Adults and Children in China, Italy, and Belgium

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000316
• EU PAS number:
  EUPAS1000000316
• Study ID:
  1000000316
• Official title and acronym:
  REACH study: Real-World Evidence study of OM-85 in Adults and Children in China, Italy, and Belgium
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  China

  Italy
• Study description:
  This non-interventional study is designed to investigate the effectiveness of OM-85 in the prevention of Respiratory Tract Infection (RTI) episodes and to understand the management of patients with RTI. The objectives will be studied separately in Belgium, Italy and China and will include description and comparison of RTI episodes before and after initiating OM-85 treatment, comparison of RTI episodes in patients initiating OM-85 treatment and in a non-user group, pattern of prescription of OM-85, antibiotics and other concomitant medications of interest, and healthcare resource utilisation. ; ; As primary objectives, the effectiveness of OM-85 is assessed through (1) a before-after design, comparing the rate of RTI episodes before and after initiation of OM-85, and (2) a comparative effectiveness design, comparing the rate of RTI episodes during follow-up between patients who initiated OM-85 and patients who did not initiate OM-85.; ; The Target Trial Emulation is used as the framework for the design of this non-interventional study. ; The study period will start from the date of earliest data availability and end at the date of latest data availability in each of the data sources. The study period will include an inclusion period, a baseline period, an initiation grace period and a follow-up period. The outcomes will be assessed at 3, 6, 9, 12, and 24 months after the initiation grace period, as per data availability. ; ; The overall study population will include patients aged ≥ 1 year of age with ≥1 RTI episodes and no prescriptions of bacterial lysates within 12 months prior to the inclusion (baseline period).
• Study status:
  Planned

Research institution and networks

Institutions

Parexel International

United States

Study timelines

Date when funding contract was signed

Planned: 14/06/2024

Study start date

Planned: 16/09/2025

Data analysis start date

Planned: 06/02/2025

Date of final study report

Planned: 30/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

OM Pharma

Study protocol

Initial protocol

Redacted Study Protocol - BV2023-14 - Final Version - 22 Nov 2024.pdf

Regulatory

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