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

June 26, 2009
August 6, 2012
November 2008
December 2010   (final data collection date for primary outcome measure)
  • 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).
Resource utilization of hospitalized patients with cIAIs; Rate of failure of initial empiric treatment in hospitalized patients with cIAIs: Impact of antibiotic resistance and initial empiric treatment on pharmacological and total healthcare costs. [ Time Frame: The duration of hospitalization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00929643 on ClinicalTrials.gov Archive Site
  • 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 ]
•To estimate prevalence rates for different pathogens responsible for cIAIs in Greek hospitals. To estimate prevalence rates of complicated intra-abdominal infections, in patients that are admitted in surgical units in Greek hospitals. [ Time Frame: The duration of hospitalization ] [ Designated as safety issue: No ]
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Not Provided
 
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients hospitalized for complicated intra-abdominal infections

Complicated Intra-Abdominal Infection
Other: no intervention
success of the initial empiric treatment
1
Intervention: Other: no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00929643
3074A1-102311, B1811060
No
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP