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

NCT00929643 | Completed Results

• 2 other identifiers: 3074A1-102311B1811060
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Complicated Intra-Abdominal Infection

Keywords

health care costs; Intra-Abdominal Infection

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Percentage of Participants With Specific Pathogen

  Baseline up to 6 months

• Percentage of Participants by Diagnosis at Discharge

  Month 6 or study exit

Study Arms (1)

1

Other: no intervention

Interventions

no intervention OTHER

success of the initial empiric treatment

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for complicated intra-abdominal infections

You may qualify if:

• 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;

You may not qualify if:

• Patients not signing an informed consent form.
• Patients participating in another interventional study.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead
• Pfizer: collaborator

Study Sites (13)

Pfizer Investigational Site

Athens, Athens, 115 24, Greece

Location

Pfizer Investigational Site

Athens, Athens, 115 26, Greece

Location

Pfizer Investigational Site

Cholargós, Athens, 115 27, Greece

Location

Pfizer Investigational Site

Haidari, Athens, 124 62, Greece

Location

Pfizer Investigational Site

Marousi, Athens, 151 26, Greece

Location

Pfizer Investigational Site

N. Ionia, Athens, 142 33, Greece

Location

Pfizer Investigational Site

Peireus, Athens, 184 54, Greece

Location

Pfizer Investigational Site

Rio, Patras, 26500, Greece

Location

Pfizer Investigational Site

Thessaloniki, Thessaloniki, 546 35, Greece

Location

Pfizer Investigational Site

Thessaloniki, Thessaloniki, 546 42, Greece

Location

Pfizer Investigational Site

Thessaloniki, Thessaloniki, 54636, Greece

Location

Pfizer Investigational Site

Thessaloniki, Thessaloniki, 56429, Greece

Location

Pfizer Investigational Site

Heraklion, Vrete, 70013, Greece

Location

Related Links

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

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 29, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 10, 2012
• Results First Posted: August 6, 2012

Record last verified: 2012-08

Locations

GR (13)