Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients
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ClinicalTrials.gov Identifier: NCT00454272 |
Recruitment Status
:
Completed
First Posted
: March 30, 2007
Last Update Posted
: March 6, 2009
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Sponsor:
Sanofi
Information provided by:
Sanofi
Tracking Information | ||||
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First Submitted Date ICMJE | March 29, 2007 | |||
First Posted Date ICMJE | March 30, 2007 | |||
Last Update Posted Date | March 6, 2009 | |||
Study Start Date ICMJE | January 2005 | |||
Actual Primary Completion Date | August 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The primary efficacy parameter will be the Response [ Time Frame: 4 to 6 days after study drug discontinuation. ] | |||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00454272 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Safety will be assessed for all randomized patients who received at least one dose [ Time Frame: 1 month after the last dose of the drug ] | |||
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients | |||
Official Title ICMJE | Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients | |||
Brief Summary | The aim of the study is to evaluate the efficacy and safety of Teicoplanin versus Vancomycin as part of the initial antibiotic regimen in the therapy of patients with fever and neutropenia . | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
197 | |||
Original Enrollment ICMJE |
250 | |||
Actual Study Completion Date | August 2007 | |||
Actual Primary Completion Date | August 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 2 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Turkey | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00454272 | |||
Other Study ID Numbers ICMJE | M000507_6004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Medical Affairs Study Director, sanofi-aventis | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | March 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |