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Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00454272
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : March 6, 2009
Information provided by:

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 .

Condition or disease Intervention/treatment Phase
Infection Febrile Neutropenia Drug: Teicoplanin Drug: Vancomycin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients
Study Start Date : January 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Arm Intervention/treatment
Active Comparator: 1, Vancomycin
Drug: Vancomycin
Active Comparator: 2, Teicoplanin
Drug: Teicoplanin

Primary Outcome Measures :
  1. The primary efficacy parameter will be the Response [ Time Frame: 4 to 6 days after study drug discontinuation. ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Will initiate study drug treatment in the hospital;
  • Has a life expectancy exc. 1 month.Is male or a non-pregnant, non-lactating female, who is post-menopausal, surgically sterilized; or has been using one or more birth control methods for at least two months prior to study entry.
  • Effective contraception must continue for at least 30 days after treatment discontinuation;

Exclusion Criteria:

  • Has a history of suspected or documented Type I hypersensitivity reaction (e.g. anaphylactic or anaphylactoid shock, respiratory distress from bronchospasm or rash) to glycopeptides (vancomycin or teicoplanin), aminoglycosides, b-lactams or cephalosporins
  • Has renal dysfunction requiring dialysis ;
  • Has neutropenia associated with a syndrome that is not generally thought to be associated with a high risk of bacterial infection (e.g., chronic benign neutropenia);
  • Is in blast crisis of chronic myeloid leukemia;
  • Has a known underlying immunocompromising disease likely to interfere with the evaluation of therapeutic response, such as infection with human immunodeficiency virus (HIV) ;
  • Had isolation and identification of a specific pathogen suspected to be responsible for fever ;Has documented colonization with vancomycin-resistant Enterococcus faecium or with Enterococcus faecalis
  • Had received more than one dose of a systemic (whether oral or parenteral) antibiotic within 3 calendar days preceding the initial therapy for this episode of fever;
  • Has received oral vancomycin for prophylaxis of Gram-positive infection;
  • Requires addition of anti-viral, anti-anaerobic or anti-fungal coverage at the same time as study medication; however, antiviral or antifungal prophylaxis is allowed, provided that it is not started at the same time than study medication.
  • Has suspected, invasive fungal disease (e.g. image of necrotic pneumonia), peri-rectal infection, liver abscess, or necrotizing enterocolitis (typhlitis).
  • Had a negative serum or urine laboratory pregnancy test (for all women except those post-menopausal or surgically sterilized).
  • The patient has one of the following:Leukemia, lymphoma, Hodgkin's disease, solid tumors or who had undergone bone marrow transplantation (for any reason)
  • Had neutropenia at the time of initiation of initial empiric antibiotic therapy, defined as <500 neutrophils/mm3 of blood; or if ³500 but <1,000 neutrophils/mm3 and expected to fall below 500 neutrophils/mm3 within 48 hours.
  • Has at least one of the following conditions:
  • clinically obvious, serious catheter-related infections. For a patient with documented catheter-related infection due to an organism other than coagulase negative staphylococci, the catheter has been removed within 24 hours of identification (removal over a guidewire is permitted).
  • Intensive chemotherapy that produces substantial mucosal damage (i.e., high-dose cytarabine (> 1 g/m2/day, which increases the risk for penicillin resistant streptococcal infections, particularly those due to viridans streptococci);
  • prophylaxis with quinolones before the onset of the febrile episode; known colonization with pneumococci that are resistant to penicillin and -cephalosporins or methicillin-resistant S. aureus; a blood culture positive for gram-positive bacteria before final identification and susceptibility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00454272

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Sanofi aventis administrative office
Istanbul, Turkey
Sponsors and Collaborators
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Study Director: Edibe Taylan Sanofi
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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00454272    
Other Study ID Numbers: M000507_6004
First Posted: March 30, 2007    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2009
Keywords provided by Sanofi:
Gram positive infection
Additional relevant MeSH terms:
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Febrile Neutropenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Anti-Bacterial Agents
Anti-Infective Agents