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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Haidari, Athens, 124 62 Greece
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Intra-Abdominal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients not signing an informed consent form.

- Patients participating in another interventional study.

NCT00929643
Pfizer
Completed
Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections

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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00929643
3074A1-102311
B1811060
No
Not Provided
Not Provided
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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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