PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

• Number of Participants With the Usage of Doripenem as Per the Approved Indication [ Time Frame: 5 to 14 days ] [ Designated as safety issue: No ]
  Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization
  
  
• Number of Participants With Different Mode of Usage of Doripenem [ Time Frame: 5 to 14 days ] [ Designated as safety issue: No ]
  
• Duration of Antibiotic Therapy [ Time Frame: 5 to 14 days ] [ Designated as safety issue: No ]
  Duration of doripenem and duration of doripenem plus oral antibiotics therapy
  
  
• Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score [ Time Frame: Baseline (Day -1) ] [ Designated as safety issue: No ]
  APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.
  
  

• Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) [ Time Frame: Day 5 or Day 7 or Day 14 ] [ Designated as safety issue: No ]
  
• Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit [ Time Frame: End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days ] [ Designated as safety issue: No ]
  
• Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit [ Time Frame: Day 5 or Day 7 or Day 14 ] [ Designated as safety issue: No ]
  
• Medical Resource Utilization [ Time Frame: From Baseline (Day -1) upto the duration of hospital stay of a participant ] [ Designated as safety issue: No ]
  Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.
  
  
• Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) [ Time Frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14) ] [ Designated as safety issue: No ]
  
• Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) [ Time Frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14) ] [ Designated as safety issue: No ]
  

This is a Phase 4, prospective, open-label, non-comparative, multicenter study to characterize the usage of doripenem in selected hospitals in the Asia Pacific region. Doripenem belongs to the carbapenem class which is a broad-spectrum antibiotic given to treat patients with serious infections, such as pneumonia and complicated intra-abdominal infections. Physicians in the selected hospital or hospital unit will refer potential patients to the study team. Patients will include men and women 18 years of age and older, hospitalized either in the Intensive Care Unit (ICU) or ward, with a diagnosis of pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. The study has 3 phases: a pretreatment phase with a 1-day screening/baseline visit, a treatment phase of 5 to 14 days, and a post-treatment phase consisting of an end-of-treatment (EOT)/early withdrawal visit to be conducted within 24 hours after the last dose of antimicrobial therapy, a test of cure (TOC) visit 7 to 14 days after EOT, a Day 28 visit, and a post-discharge visit 28 days after discharge from the hospital. Usage of Doripenem in terms of approved indications, mode of usage, duration of antibiotic therapy, and patient characteristics will be assessed. Safety will be assessed through monitoring for adverse events, serial physical examinations, and the collection of conventional laboratory data (chemistry panel, complete blood count with differential). Being a prospective study, patient data will be gathered as the patients are enrolled, starting with their present condition and following them until duration of the study. The study will not compare Doripenem with other antibiotics for the primary endpoint. One vial (500mg) of doripenem intravenously (by injection) every 8 hours for 5 to 14 days