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Completed

NCT Number: NCT00929643

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.

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Key information

Conditions

Complicated Intra-abdominal Infection Infections Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

success of the initial empiric treatment

Primary outcomes

  1. Duration of Hospitalization

    Time frame: Baseline up to 6 months

    Overall health care resource utilization was analyzed using mean duration of hospitalization.

  2. Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)

    Time frame: Baseline up to 6 months

  3. 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.

  4. 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 outcomes

  1. Percentage of Participants With Specific Pathogen

    Time frame: Baseline up to 6 months

  2. Percentage of Participants by Diagnosis at Discharge

    Time frame: Month 6 or study exit

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2009
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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