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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00454272 |
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 .
Condition | Intervention | Phase |
---|---|---|
Infection Febrile Neutropenia |
Drug: Teicoplanin Drug: Vancomycin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients |
Enrollment: | 197 |
Study Start Date: | January 2005 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1, Vancomycin: Active Comparator
Vancomycin
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Drug: Vancomycin |
2, Teicoplanin: Active Comparator
Teicoplanin
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Drug: Teicoplanin |
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | M000507_6004 |
Study First Received: | March 29, 2007 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00454272 History of Changes |
Health Authority: | Turkey: Ministry of Health |
febrile neutropenia cancer Gram positive infection |
Fever Anti-Infective Agents Anti-Bacterial Agents Signs and Symptoms Neutropenia Teicoplanin |
Hematologic Diseases Agranulocytosis Vancomycin Leukocyte Disorders Leukopenia Granulocytopenia |
Anti-Infective Agents Teicoplanin Hematologic Diseases Agranulocytosis Leukocyte Disorders Body Temperature Changes Infection Pharmacologic Actions |
Fever Neutropenia Signs and Symptoms Anti-Bacterial Agents Therapeutic Uses Vancomycin Leukopenia |