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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929643
First Posted: June 29, 2009
Last Update Posted: August 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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.

Condition Intervention
Complicated Intra-Abdominal Infection Other: no intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Duration of Hospitalization [ Time Frame: Baseline up to 6 months ]
    Overall health care resource utilization was analyzed using mean duration of hospitalization.

  • Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) [ Time Frame: Baseline up to 6 months ]
  • Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy [ Time Frame: Baseline up to 6 months ]
    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.

  • Duration of Hospitalization (by Failure of Initial Empiric Treatment) [ Time Frame: Baseline up to 6 months ]
    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).


Secondary Outcome Measures:
  • Percentage of Participants With Specific Pathogen [ Time Frame: Baseline up to 6 months ]
  • Percentage of Participants by Diagnosis at Discharge [ Time Frame: Month 6 or study exit ]

Enrollment: 203
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: no intervention
success of the initial empiric treatment

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized for complicated intra-abdominal infections
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929643


Locations
Greece
Pfizer Investigational Site
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
Rio, Patras, Greece, 26500
Pfizer Investigational Site
Herakleion, Vrete, Greece, 70013
Pfizer Investigational Site
Athens, Greece, 115 24
Pfizer Investigational Site
Athens, Greece, 115 26
Pfizer Investigational Site
Thessaloniki, Greece, 546 35
Pfizer Investigational Site
Thessaloniki, Greece, 546 42
Pfizer Investigational Site
Thessaloniki, Greece, 54636
Pfizer Investigational Site
Thessaloniki, Greece, 56429
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00929643     History of Changes
Other Study ID Numbers: 3074A1-102311
B1811060
First Submitted: June 26, 2009
First Posted: June 29, 2009
Results First Submitted: June 27, 2012
Results First Posted: August 6, 2012
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
health care costs
Intra-Abdominal Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Intraabdominal Infections