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

Complicated Intra-Abdominal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929643
• Other study ID #: 3074A1-102311
• Secondary ID: B1811060
• Status: Completed
• Phase: N/A
• First received: June 26, 2009
• Last updated: August 6, 2012
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Intra-Abdominal Infection
• Infection
• Intraabdominal Infections

Intervention

Other:
• no intervention
success of the initial empiric treatment

Locations

Country	Name	City	State
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Haidari	Athens
Greece	Pfizer Investigational Site	Herakleion	Vrete
Greece	Pfizer Investigational Site	Holargos	Athens
Greece	Pfizer Investigational Site	Marousi	Athens
Greece	Pfizer Investigational Site	N. Ionia	Athens
Greece	Pfizer Investigational Site	Peireus	Athens
Greece	Pfizer Investigational Site	Rio	Patras
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Hospitalization	Overall health care resource utilization was analyzed using mean duration of hospitalization.	Baseline up to 6 months	No
Primary	Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)		Baseline up to 6 months	No
Primary	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	No
Primary	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	No
Secondary	Percentage of Participants With Specific Pathogen		Baseline up to 6 months	No
Secondary	Percentage of Participants by Diagnosis at Discharge		Month 6 or study exit	No

External Links

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