A Multicenter, Prospective, Observational Study Investigating Clinical Outcomes Associated with Antimicrobial Therapy among Chinese Patients with Complicated Intraabdominal Infections in the Real-World Clinical Practice

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42203
• EU PAS number:
  EUPAS42202
• Study ID:
  42203
• Official title and acronym:
  A Multicenter, Prospective, Observational Study Investigating Clinical Outcomes Associated with Antimicrobial Therapy among Chinese Patients with Complicated Intraabdominal Infections in the Real-World Clinical Practice
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  Antimicrobial resistance has increasingly been seen in cIAIs worldwide including China. But there have been limited studies to generate real-world evidence on clinical outcomes associated with antimicrobial therapy and microbiology profiles in Chinese patients with cIAIs. The study was designed to investigate the rate of favourable clinical response to antimicrobial therapy at the clinical evaluation in Chinese patients who have cIAIs and are clinically evaluable (CE). The study is a multicenter, prospective, observational study with descriptive analyses on one single patient cohort. Chinese patients with cIAIs requiring hospitalization for surgical interventions and antimicrobial therapy will be enrolled in a period of approximately 18 months.
• Study status:
  Planned

Research institutions and networks

Institutions

Shanghai Jiao Tong University School of Medicine - Xinhua Hospital

Study timelines

Date when funding contract was signed

Planned: 26/08/2021

Study start date

Planned: 02/09/2021

Data analysis start date

Planned: 14/03/2003

Date of final study report

Planned: 25/08/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme

Regulatory

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