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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:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00929643
First received: June 26, 2009
Last updated: August 6, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of Participants by Diagnosis at Discharge [ Time Frame: Month 6 or study exit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 56429
Pfizer Investigational Site
Thessaloniki, Greece, 54636
Pfizer Investigational Site
Thessaloniki, Greece, 546 35
Pfizer Investigational Site
Thessaloniki, Greece, 546 42
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:
No publications provided

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
Study First Received: June 26, 2009
Results First Received: June 27, 2012
Last Updated: August 6, 2012
Health Authority: Greece: National Organization of Medicines

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

Additional relevant MeSH terms:
Communicable Diseases
Infection
Intraabdominal Infections

ClinicalTrials.gov processed this record on November 25, 2014