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

March 29, 2007
March 5, 2009
January 2005
August 2007   (final data collection date for primary outcome measure)
The primary efficacy parameter will be the Response [ Time Frame: 4 to 6 days after study drug discontinuation. ] [ Designated as safety issue: No ]
  • The primary efficacy parameter will be the Response according to the following
  • definitions:
  • Success: All signs and symptoms have resolved and there were no additional
  • systemic antibiotics added to the study drug regimen. There were no systemic
  • antifungals nor antivirals/antiparasitic drugs added within 72 hrs of start of
  • study drug. For MDIs, there was no recurrence of the causative pathogen within
  • 4 to 6 days after study drug discontinuation. A patient with recurrent fever
  • after the EOT visit will be defined as a success as long as there is no
  • additional anti-Gram(+) drugs administered within 4 to 6 days after study drug
  • discontinuation.
  • Failure: Death attributed to infection; clinical deterioration or microbiologic
  • failure on study drug regimen; persistence of symptoms; addition of new anti-Gram(+)
  • agent for persistent symptoms or new infection; resistant isolate. Addition of
  • an antiviral, an antiparasitic (for a specific indication) or of an antifungal
  • drug will not be considered as a failure if added 72hrs after start of study
  • medication. Indeterminate: Absence of criteria enabling success/ failure a
  • assessment (this definition apply to patients who are randomized but not treated
  • or to patients lost to follow-up).Whenever a patient is categorized a failure,
  • this classification will apply to subsequent assessments.
Complete list of historical versions of study NCT00454272 on ClinicalTrials.gov Archive Site
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 ]
  • Safety will be assessed for all randomized patients who received at least one dose
  • of study medication. The assessment will include the incidence rate of clinical
  • adverse events, and changes in laboratory values from baseline measurements. The
  • incidence of adverse events by body system will be summarized by causality,
  • severity, and relationship to study drug. Summaries of adverse clinical events
  • ill also be presented separately by gender, race and age group.
Not Provided
Not Provided
 
Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients
Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients

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 .

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infection
  • Febrile Neutropenia
  • Drug: Teicoplanin
  • Drug: Vancomycin
  • Active Comparator: 1, Vancomycin
    Vancomycin
    Intervention: Drug: Vancomycin
  • Active Comparator: 2, Teicoplanin
    Teicoplanin
    Intervention: Drug: Teicoplanin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00454272
M000507_6004
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Edibe Taylan Sanofi
Sanofi
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP