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

NCT00454272 | Completed Phase 4

• 1 other identifier: M000507_6004
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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 .

Conditions

Infection; Febrile Neutropenia

Keywords

febrile; neutropenia; cancer; Gram positive infection

Outcome Measures

Primary Outcomes (1)

• The primary efficacy parameter will be the Response

  4 to 6 days after study drug discontinuation.

Secondary Outcomes (1)

• Safety will be assessed for all randomized patients who received at least one dose

  1 month after the last dose of the drug

Study Arms (2)

1, Vancomycin

ACTIVE COMPARATOR

Vancomycin

Drug: Vancomycin

2, Teicoplanin

ACTIVE COMPARATOR

Teicoplanin

Drug: Teicoplanin

Interventions

Teicoplanin DRUG

2, Teicoplanin

Vancomycin DRUG

1, Vancomycin

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi aventis administrative office

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infections; Febrile Neutropenia; Fever; Neutropenia; Neoplasms

Interventions

Teicoplanin; Vancomycin

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipoglycopeptides; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Edibe Taylan

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: March 30, 2007
• Study Start: January 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 6, 2009

Record last verified: 2009-03

Locations

TU (1)