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

Phase 4
2 Years
Not Enrolling
Infection, Febrile Neutropenia

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Trial Information

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

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy parameter will be the Response

Outcome Time Frame:

4 to 6 days after study drug discontinuation.

Safety Issue:


Principal Investigator

Edibe Taylan

Investigator Role:

Study Director

Investigator Affiliation:



Turkey: Ministry of Health

Study ID:




Start Date:

January 2005

Completion Date:

August 2007

Related Keywords:

  • Infection
  • Febrile Neutropenia
  • febrile
  • neutropenia
  • cancer
  • Gram positive infection
  • Fever
  • Neutropenia