Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 26, 2009 | ||||
| Last Updated Date | August 6, 2012 | ||||
| Start Date ICMJE | November 2008 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE |
Resource utilization of hospitalized patients with cIAIs; Rate of failure of initial empiric treatment in hospitalized patients with cIAIs: Impact of antibiotic resistance and initial empiric treatment on pharmacological and total healthcare costs. [ Time Frame: The duration of hospitalization ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00929643 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
•To estimate prevalence rates for different pathogens responsible for cIAIs in Greek hospitals. To estimate prevalence rates of complicated intra-abdominal infections, in patients that are admitted in surgical units in Greek hospitals. [ Time Frame: The duration of hospitalization ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections | ||||
| Official Title ICMJE | 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 ICMJE | Observational | ||||
| Study Design ICMJE | 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 ICMJE | Complicated Intra-Abdominal Infection | ||||
| Intervention ICMJE | Other: no intervention
success of the initial empiric treatment |
||||
| Study Group/Cohort (s) | 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 203 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Greece | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00929643 | ||||
| Other Study ID Numbers ICMJE | 3074A1-102311, B1811060 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
| Verification Date | August 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||