Post-Marketing Study to Assess the Effectiveness and Safety of RECARBRIO in Chinese Adult Patients With Limited or No Alternative Treatment Options for Susceptible Gram-Negative Bacterial Infections (MK-7655A-035)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001027
• Study ID:
  1000001027
• Official title and acronym:
  Post-Marketing Study to Assess the Effectiveness and Safety of RECARBRIO in Chinese Adult Patients With Limited or No Alternative Treatment Options for Susceptible Gram-Negative Bacterial Infections (MK-7655A-035)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This study is being conducted to better understand how well the antibiotic RECARBRIO works and how safe it is when used in everyday medical practice in China. Serious infections caused by Gram-negative bacteria are becoming harder to treat because many antibiotics are no longer effective. Patients with these infections may have very limited or no other treatment options, creating an urgent need for effective and safe therapies. Although RECARBRIO has already been approved for use in China based on clinical trials, there is limited information on how it performs in real-world settings, especially in Chinese patients. The main objective of the study is to evaluate how well RECARBRIO works by determining how many patients show improvement or complete recovery from their infection after treatment. The study will also assess safety by tracking whether patients experience side effects or adverse reactions during treatment and in the period shortly after treatment ends. This study will describe the real-world effectiveness of RECARBRIO in Chinese adult patients with limited or no alternative treatment options for susceptible Gram negative bacterial infections.
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Actual:01/06/2026

Study start date

Planned:30/10/2026

Data analysis start date

Planned:30/04/2028

Date of final study report

Planned:31/12/2028

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)?:
  Not applicable