A post-marketing database surveillance to investigate the risk of diagnosed lactic acidosis events in MRSA patients treated with tedizolid or linezolid in Japan (MK-1986-046)

Study identification

• EU PAS number:
  EUPAS1000000894
• Study ID:
  1000000894
• Official title and acronym:
  A post-marketing database surveillance to investigate the risk of diagnosed lactic acidosis events in MRSA patients treated with tedizolid or linezolid in Japan (MK-1986-046)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The main objective of this study is to compare the risk of diagnosed lactic acidosis events in patients with Methicillin-resistant Staphylococcus aureus (MRSA) taking either tedizolid or linezolid in Japan. The study will be conducted to determine whether the risk of diagnosed lactic acidosis is higher with tedizolid use compared to linezolid.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

Networks

Medical Information Database NETwork (MID-NET)

Study timelines

Date when funding contract was signed

Actual:29/05/2025

Study start date

Actual:09/12/2025

Data analysis start date

Planned:28/02/2026

Date of final study report

Planned:17/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Regulatory

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