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

Wyeth

Status: Completed

Conditions: Complicated Intra-Abdominal Infection

Treatments: Other: no intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00929643

3074A1-102311

B1811060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

203 participants in 1 patient group

1

Treatment:

Other: no intervention