- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00454272
Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients
March 5, 2009 updated by: Sanofi
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 .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
197
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Sanofi aventis administrative office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1, Vancomycin
Vancomycin
|
|
ACTIVE_COMPARATOR: 2, Teicoplanin
Teicoplanin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy parameter will be the Response
Time Frame: 4 to 6 days after study drug discontinuation.
|
4 to 6 days after study drug discontinuation.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 month after the last dose of the drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (ACTUAL)
August 1, 2007
Study Completion (ACTUAL)
August 1, 2007
Study Registration Dates
First Submitted
March 29, 2007
First Submitted That Met QC Criteria
March 29, 2007
First Posted (ESTIMATE)
March 30, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
March 6, 2009
Last Update Submitted That Met QC Criteria
March 5, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M000507_6004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Febrile Neutropenia
-
Institut RafaelActive, not recruitingPatient Satisfaction | Patient Preference | Febrile Neutropenia, Drug-InducedFrance
-
Hospira, now a wholly owned subsidiary of PfizerCompletedSolid Tumors | Malignant Hemopathy | Chemotherapy-induced Febrile Neutropenia (FN)France
-
University Hospital, BrestCompletedNeutropenia, FebrileFrance
-
TTY BiopharmCompletedNeutropenia, FebrileTaiwan
-
Kjeld SchmiegelowRecruitingPediatric Cancer | Neutropenia, FebrileDenmark
-
AmgenCompletedChemotherapy-induced Febrile NeutropeniaFrance, Italy, Poland, Canada, Spain, Austria, Germany, Greece, Romania, Australia, Ireland
-
University Hospital, LilleMinistry of Health, FranceRecruiting
-
Hospital Infantil de Mexico Federico GomezHospital Juarez de Mexico; Instituto Nacional de PediatriaCompletedChemotherapy-Induced Febrile Neutropenia
-
All India Institute of Medical Sciences, New DelhiTerminatedPediatric Cancer | Neutropenia, FebrileIndia
-
PfizerCompletedNon-Interventional StudyGermany
Clinical Trials on Vancomycin
-
Case Western Reserve UniversityCystic Fibrosis FoundationWithdrawnCystic Fibrosis | Methicillin-resistant Staphylococcus AureusUnited States
-
St. Luke's Hospital, Chesterfield, MissouriCompletedClostridium Difficile Infection | Prophylaxis | Vancomycin
-
University of FloridaCompleted
-
Alberta Hip and Knee ClinicUniversity of CalgaryNot yet recruitingInfection of Total Hip Joint Prosthesis | Infection of Total Knee Joint Prosthesis
-
Memorial Sloan Kettering Cancer CenterCompletedHematologic Malignancies | Streptococcal SepsisUnited States
-
The Methodist Hospital Research InstituteRecruiting
-
Washington University School of MedicineTerminatedSurgical Site InfectionUnited States
-
William Beaumont HospitalsBeaumont HospitalWithdrawnClostridium Difficile ColitisUnited States
-
The Canberra HospitalUnknown
-
Universidad Autonoma de Nuevo LeonCompletedComplication of Surgical Procedure | Surgical Site InfectionMexico