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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01DH) Carbapenems

  Carbapenems

  (J01DI) Other cephalosporins and penems

  Other cephalosporins and penems
• Medical condition to be studied:
  Abdominal infection

  Gastrointestinal infection

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  980

Study design details

• Main study objective:
  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).
• Outcomes:
  Favourable clinical response to antimicrobial therapy at the clinical evaluation in Chinese patients who have cIAIs and are clinically evaluable (CE), 1. Favourable clinical response to antimicrobial therapy at the clinical evaluation in ME, 2. Favourable clinical response to antimicrobial therapy at the end of antibiotic course 3. Appropriateness of empiric antimicrobial therapy, 4. Hospital readmission at the late clinical evaluation, 5. Clinical characteristics associated with favourable clinical response to antimicrobial therapy.
• Data analysis plan:
  Descriptive statistics by point estimate with Wilson score 95% CIs, multivariate logistic regression to identify predictors associated with treatment success.