Clinical Trial: Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: The Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Brief Summary: The objective of this study is to estimate the costs of empiric antibiotic therapy and hospitalization costs for patients with a complicated intra-abdominal infection, and to assess the impact of treatment failure of initial antibiotic empiric therapy on pharmacological and total healthcare costs for these patients in Greece.
Detailed Summary: Every patient diagnosed with complicated intra-abdominal infections will enter the study, until the pre-specified number of patients is reached. Patients diagnosed with any of conditions mentioned below (inclusion criteria) will enter the study, until the pre-specified number of patients is reached.
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Current Primary Outcome:
- Duration of Hospitalization [ Time Frame: Baseline up to 6 months ]Overall health care resource utilization was analyzed using mean duration of hospitalization.
- Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) [ Time Frame: Baseline up to 6 months ]
- Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy [ Time Frame: Baseline up to 6 months ]Failure of initial empiric therapy was assessed by an independent committee of qualified healthcare professionals (surgeon, and microbiologist specialist) and defined as requirement of additional antibiotic or change in antibacterial therapy on any day following the initial laparotomy, laparoscopy, or percutaneous drainage; or additional laparotomy, laparoscopy, or percutaneous drainage at least 2 days following the initial surgical/radiological intervention; or participant death due to infection.
- Duration of Hospitalization (by Failure of Initial Empiric Treatment) [ Time Frame: Baseline up to 6 months ]Yes equals (=) initial empiric antibiotic treatment failed (additional antibiotic therapy or a change in antibacterial therapy was required following laparotomy/laparoscopy or percutaneous draininge or participant died due to infection); No=initial empiric antibiotic treatment successful (infectious process resolved and no change in initial empiric antibiotic therapy was required during the course of hospitalization except for stepdown therapy, de-escalation or intravenous to oral switch).
Original Primary Outcome: Resource utilization of hospitalized patients with cIAIs; Rate of failure of initial empiric treatment in hospitalized patients with cIAIs: Impact of antibiotic resistance and initial empiric treatment on pharmacological and total healthcare costs. [ Time Frame: The duration of hospitalization ]
Current Secondary Outcome:
- Percentage of Participants With Specific Pathogen [ Time Frame: Baseline up to 6 months ]
- Percentage of Participants by Diagnosis at Discharge [ Time Frame: Month 6 or study exit ]
Original Secondary Outcome: •To estimate prevalence rates for different pathogens responsible for cIAIs in Greek hospitals. To estimate prevalence rates of complicated intra-abdominal infections, in patients that are admitted in surgical units in Greek hospitals. [ Time Frame: The duration of hospitalization ]
Information By: Wyeth is now a wholly owned subsidiary of Pfizer
Dates:
Date Received: June 26, 2009
Date Started: November 2008
Date Completion:
Last Updated: August 6, 2012
Last Verified: August 2012
