Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00481962
First received: May 31, 2007
Last updated: September 25, 2009
Last verified: September 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 31, 2007 | ||||||||
| Last Updated Date | September 25, 2009 | ||||||||
| Start Date ICMJE | February 2006 | ||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00481962 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs) | ||||||||
| Official Title ICMJE | Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units | ||||||||
| Brief Summary | The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost analysis from a hospital perspective (including length of stay, treatment costs, side effect management costs, costs of monitoring, costs of diagnostic procedures, cost of care (TISS 10 score etc.); Efficacy of Tygacil under usual care conditions (cure rate). |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | primary care clinical |
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| Condition ICMJE | Peritonitis | ||||||||
| Intervention ICMJE | Drug: Tygacil
Initial dose of 100mg followed by 50mg every 12 hours for 5 to 14 days |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 180 | ||||||||
| Completion Date | December 2008 | ||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| 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 | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00481962 | ||||||||
| Other Study ID Numbers ICMJE | 3074A1-102184 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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