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

Last updated on October 15, 2019

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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cIAIs Complicated Intra-Abdominal Infections
NCT02655419
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief TitleImpact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Official TitleThe Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Brief SummaryThe 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 DescriptionEvery 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 TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients hospitalized for complicated intra-abdominal infections
ConditionComplicated Intra-Abdominal Infection
InterventionOther: no intervention
success of the initial empiric treatment
Study Groups/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: January 18, 2011)
203
Original Estimated Enrollment
 (submitted: June 26, 2009)
300
Actual Study Completion DateDecember 2010
Actual Primary Completion DateDecember 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGreece
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00929643
Other Study ID Numbers3074A1-102311
B1811060
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsPfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateAugust 2012

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

Contact

[email protected]

Call Now