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

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NCT00929643

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Study Location
Pfizer Investigational Site
Haidari, Athens, 124 62, Greece
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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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.

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Advanced Information
Descriptive Information
Brief Title Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Official Title The Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
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.
Detailed 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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients hospitalized for complicated intra-abdominal infections
Condition Complicated Intra-Abdominal Infection
Intervention Other: no intervention
success of the initial empiric treatment
Study Groups/Cohorts 1
Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 18, 2011)		203
Original Estimated Enrollment
 (submitted: June 26, 2009)		300
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT00929643
Other Study ID Numbers 3074A1-102311
B1811060
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Pfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2012