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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Complicated Intra-Abdominal Infection

Keywords

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health care costs Intra-Abdominal Infection

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

no intervention

Intervention Type OTHER

success of the initial empiric treatment

Interventions

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no intervention

success of the initial empiric treatment

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

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B1811060

Identifier Type: -

Identifier Source: secondary_id

3074A1-102311

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

no intervention

Interventions

no intervention

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pfizer

Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party

Principal Investigators

Pfizer CT.gov Call Center

Locations

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Countries

Related Links

Other Identifiers

B1811060

3074A1-102311