Clinical trial NCT00929643: Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Official title: The Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complicated Intra-Abdominal Infection
Keywords: health care costs
Intra-Abdominal Infection
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-06-29
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Hospitalization
timeFrame: Baseline up to 6 months
measure: Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
timeFrame: Baseline up to 6 months
measure: Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy
timeFrame: Baseline up to 6 months
measure: Duration of Hospitalization (by Failure of Initial Empiric Treatment)
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Percentage of Participants With Specific Pathogen
timeFrame: Baseline up to 6 months
measure: Percentage of Participants by Diagnosis at Discharge
timeFrame: Month 6 or study exit
Other outcomes:
Locations:
city: Haidari
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Holargos
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Marousi
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: N. Ionia
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Peireus
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Rio
country: Greece
facility: Pfizer Investigational Site
state: Patras
city: Herakleion
country: Greece
facility: Pfizer Investigational Site
state: Vrete
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: