InfectionPhase 4NCT00454272
Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients
A Phase 4 study testing Teicoplanin and Vancomycin in people with Infection and Febrile Neutropenia, run by Sanofi at 1 site in Turkey (Türkiye).
Trial 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 . Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Infection, Febrile Neutropenia
- What is being tested?
- Teicoplanin and Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2005to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Teicoplanin, Vancomycin
- Keywords
- febrile, neutropenia, cancer, Gram positive infection
- Medical subject headings
- Infections, Febrile Neutropenia, Fever, Neutropenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeicoplaninDrug
VancomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| 1, Vancomycin | Active comparator | Vancomycin Receives: Drug: Vancomycin |
| 2, Teicoplanin | Active comparator | Teicoplanin Receives: Drug: Teicoplanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter will be the Response
Measured: 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
Measured: 1 month after the last dose of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startJan 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edibe Taylan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454272
- Sponsor's protocol ID
- M000507_6004
- Status last verified
- Mar 2009
- First submitted
- 29 Mar 2007
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Teicoplanin and Vancomycin in Initial Empirical Antibiotic Regimen for Febrile Neutropenic Patients
- ClinicalTrials.gov ID
- NCT00454272
- Acronym / sponsor ID
- M000507_6004
- Conditions
- Infection, Febrile Neutropenia
- Keywords
- febrile, neutropenia, cancer, Gram positive infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, Vancomycin | Active comparator | Drug: VancomycinVancomycin |
| 2, Teicoplanin | Active comparator | Drug: TeicoplaninTeicoplanin |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (17 listed)
- 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) ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teicoplanin | Drug | 2, Teicoplanin |
| Vancomycin | Drug | 1, Vancomycin |
Primary outcome
The primary efficacy parameter will be the Response
Time frame: 4 to 6 days after study drug discontinuation.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edibe Taylan study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teicoplanin and Vancomycin in people with Infection and Febrile Neutropenia, run by Sanofi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy parameter will be the Response (time frame: 4 to 6 days after study drug discontinuation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2009.