Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
NCT00929643
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- 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.
- Patients not signing an informed consent form.
- Patients participating in another interventional study.
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| 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 | 203 | |||
| Original Estimated Enrollment | 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:
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:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | August 2012 | |||