Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections

Completed

Conditions: Complicated Intra-Abdominal Infection

Interventions: Other: no intervention

Registration Number: NCT00929643

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 203

Inclusion Criteria

A recorded primary diagnosis of a complicated intra-abdominal. infection (cIAI) and a procedure involving a laparotomy, laparoscopy, or percutaneous drainage of an intra-abdominal abscess The study will be a prospective, multi-centre, epidemiological study of patients (aged > 18 years) diagnosed with a complicated intra-abdominal infection AND who received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess. cIAI's will include the following conditions/ diagnoses:
Gastric ulcer with perforation;
Gastric ulcer with hemorrhage and perforation;
Duodenal ulcer with perforation;
Duodenal ulcer with hemorrhage and perforation;
Peptic ulcer with perforation;
Peptic ulcer with hemorrhage and perforation;
Gastrojejunal ulcer with perforation;
Gastrojejunal ulcer with hemorrhage and perforation;
Acute appendicitis with generalized peritonitis;
Acute appendicitis with peritoneal abscess;
Peritonitis;
Abscess of intestine;
Fistula of intestine, excluding rectum and anus;
Ulceration of intestine;
Perforation of intestine;
Abscess of liver; or
Acute cholecystitis with perforation.

The initial antibiotic regimen will be defined as all IV antibiotics newly received either on the day immediately prior to laparotomy or laparoscopy or percutaneous drainage of an intra-abdominal abscess, or on the day of these procedures, given that the use of these procedures prior to initiation of IV antibiotic regimens in complicated IAIs , which is increasingly common, is likely reflective of prophylaxis.

Exclusion Criteria

Patients not signing an informed consent form.
Patients participating in another interventional study.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	no intervention	-

Primary Outcome Measures

Name	Time	Method
Duration of Hospitalization	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)	Baseline up to 6 months
Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy	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)	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).