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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00454272
First received: March 29, 2007
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The primary efficacy parameter will be the Response [ Time Frame: 4 to 6 days after study drug discontinuation. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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
Active Comparator: 1, Vancomycin
Vancomycin
Drug: Vancomycin
Active Comparator: 2, Teicoplanin
Teicoplanin
Drug: Teicoplanin

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454272

Locations
Turkey
Sanofi aventis administrative office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Edibe Taylan Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00454272     History of Changes
Other Study ID Numbers: M000507_6004
Study First Received: March 29, 2007
Last Updated: March 5, 2009
Health Authority: Turkey: Ministry of Health

Keywords provided by Sanofi:
febrile
neutropenia
cancer
Gram positive infection

Additional relevant MeSH terms:
Fever
Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Vancomycin
Teicoplanin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 24, 2014