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

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

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.

Study Overview

• Status: Completed
• Conditions: Complicated Intra-Abdominal Infection
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 115 24
    • Pfizer Investigational Site
  • Athens, Greece, 115 26
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 54636
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 546 35
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 546 42
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 56429
    • Pfizer Investigational Site
  • Athens
    • Haidari, Athens, Greece, 124 62
      • Pfizer Investigational Site
    • Holargos, Athens, Greece, 115 27
      • Pfizer Investigational Site
    • Marousi, Athens, Greece, 151 26
      • Pfizer Investigational Site
    • N. Ionia, Athens, Greece, 142 33
      • Pfizer Investigational Site
    • Peireus, Athens, Greece, 184 54
      • Pfizer Investigational Site
  • Patras
    • Rio, Patras, Greece, 26500
      • Pfizer Investigational Site
  • Vrete
    • Herakleion, Vrete, Greece, 70013
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for complicated intra-abdominal infections

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1	Other: no intervention; success of the initial empiric treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hospitalization	Overall health care resource utilization was analyzed using mean duration of hospitalization.	Baseline up to 6 months
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	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.	Baseline up to 6 months
Duration of Hospitalization (by Failure of Initial Empiric Treatment)	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).	Baseline up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Specific Pathogen	Baseline up to 6 months
Percentage of Participants by Diagnosis at Discharge	Month 6 or study exit

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 26, 2009
• First Submitted That Met QC Criteria: June 26, 2009
• First Posted (Estimate): June 29, 2009

Study Record Updates

• Last Update Posted (Estimate): August 10, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: health care costs; Intra-Abdominal Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Intraabdominal Infections
• Other Study ID Numbers: 3074A1-102311; B1811060