Status:
COMPLETED
Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
Pfizer
Conditions:
Complicated Intra-Abdominal Infection
Eligibility:
All Genders
18+ years
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 trea...
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 bel...
Eligibility Criteria
Inclusion
- 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
- Patients not signing an informed consent form.
- Patients participating in another interventional study.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00929643
Start Date
November 1 2008
End Date
December 1 2010
Last Update
August 10 2012
Active Locations (13)
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1
Pfizer Investigational Site
Athens, Athens, Greece, 115 24
2
Pfizer Investigational Site
Athens, Athens, Greece, 115 26
3
Pfizer Investigational Site
Cholargós, Athens, Greece, 115 27
4
Pfizer Investigational Site
Haidari, Athens, Greece, 124 62