Febrile NeutropeniaPhase 3NCT00035425
Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection
A Phase 3 study testing linezolid and vancomycin in people with Febrile Neutropenia, run by Pfizer at 40 sites in 11 countries.
Trial summary
This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- linezolid and vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 40 sitesin 11 countries
- Study dates
- Nov 2001to Nov 2002
- Phase
- Phase 3
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C).
- Patients must have a cancer with recent chemotherapy and risks factors for gram positive infections.
Who cannot join
- Patients with fever due to known causes. Patients with HIV. Patients with recent bone marrow transplant. Patients with an infected indwelling catheter that cannot be removed. Patients who have received more than one day of another antibiotic before entering the trial.
- Patients with endocarditis, osteomyelitis, meningitis, CNS infections.
Trial locations and contacts
40 sites in 11 countries.
40 sites in 11 countries
United States16 sites
Pfizer Investigational Site
Federal Way, Washington, 98003
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Lakewood, Washington, 98499
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Richmond, Virginia, 23226
Pfizer Investigational Site
Richmond, Virginia, 23229
Pfizer Investigational Site
Richmond, Virginia, 23249
Pfizer Investigational Site
Richmond, Virginia, 23294-4367
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Springfield, Illinois, 62701-1014
Pfizer Investigational Site
Springfield, Illinois, 62703
Pfizer Investigational Site
Springfield, Illinois, 62769
Pfizer Investigational Site
Springfield, Illinois, 62781
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
The Bronx, New York, 10461
Pfizer Investigational Site
The Bronx, New York, 10467
Brazil6 sites
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90020-090
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
São Paulo, São Paulo, 01409-902
Pfizer Investigational Site
São Paulo, São Paulo, 01509-900
Pfizer Investigational Site
São Paulo, São Paulo, 04024-002
Pfizer Investigational Site
São Paulo, São Paulo, 05651-901
Argentina3 sites
Pfizer Investigational Site
Buenos Aires, 1094
Pfizer Investigational Site
Córdoba, 5000
Pfizer Investigational Site
Mendoza, 5500
Colombia3 sites
Pfizer Investigational Site
Bogotá, Bogota. DC, NAP
Pfizer Investigational Site
Bogotá, Bogota. DC
Pfizer Investigational Site
Medellín
Mexico3 sites
Pfizer Investigational Site
Mexico City, C.P. 02990
Pfizer Investigational Site
Monterrey, Nuevo León, C.P. 64000
Pfizer Investigational Site
Zapopan, Jalisco, 45173
Pakistan2 sites
Pfizer Investigational Site
Karachi, 74800
Pfizer Investigational Site
Lahore, Punjab Province
Peru2 sites
Pfizer Investigational Site
Lima, Lima Province, 13
Pfizer Investigational Site
Lima, Lima Province, 34
Venezuela2 sites
Pfizer Investigational Site
Caracas, Distrito Federal, 1041
Pfizer Investigational Site
Caracas, 1020
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections
This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
- Conditions
- Febrile Neutropenia
- Being tested
- linezolid, vancomycin
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linezolidDrug
Also called Zyvox
600mg every 12 hours
vancomycinDrug
1gm every 12 hours. The dose of vancomycin intravenously may be adjusted for renal function, but the patient must be able to receive a 300 mL volume of intravenous fluid at the assigned dosing times of every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| A. | Experimental | Patients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days. Receives: Drug: linezolid |
| B. | Experimental | Not described Receives: Drug: vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections.
Measured: 7-28 days
Secondary outcomes (7)
Microbiologic outcome
Measured: 7-28 days
Pathogen eradication (eradication rates of individual pathogens)
Measured: 7-28 days
Defervescence (defined as Tmax orally or rectally)
Measured: 7-28 days
Time to defervescence
Measured: 7-28 days
Resolution of neutropenia (return of ANC to >500 cells/mm3)
Measured: 7-28 days
Time to resolution of neutropenia
Measured: 7-28 days
Mortality rate (survival at 7 days after the end of therapy)
Measured: 7-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startNov 2001
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035425
- Sponsor's protocol ID
- M12600079
- Other IDs
- A5951059
- Status last verified
- Nov 2009
- First submitted
- 3 May 2002
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections
- ClinicalTrials.gov ID
- NCT00035425
- Acronym / sponsor ID
- M12600079
- Conditions
- Febrile Neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Nov 2002 (actual)
- First posted
- 6 May 2002 (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.
This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. | Experimental | Drug: linezolidPatients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days. |
| B. | Experimental | Drug: vancomycin |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have neutropenia (ANC less than 500) with fever (oral temp 38.3 C).
- Patients must have a cancer with recent chemotherapy and risks factors for gram positive infections.
Key exclusion criteria (2 listed)
- Patients with fever due to known causes. Patients with HIV. Patients with recent bone marrow transplant. Patients with an infected indwelling catheter that cannot be removed. Patients who have received more than one day of another antibiotic before entering the trial.
- Patients with endocarditis, osteomyelitis, meningitis, CNS infections.
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 |
|---|---|---|
| linezolidAlso: Zyvox600mg every 12 hours | Drug | A. |
| vancomycin1gm every 12 hours. The dose of vancomycin intravenously may be adjusted for renal function, but the patient must be able to receive a 300 mL volume of intravenous fluid at the assigned dosing times of every 12 hours. | Drug | B. |
Primary outcome
Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections.
Time frame: 7-28 days
7 secondary outcomes
Microbiologic outcome
Time frame: 7-28 days
Pathogen eradication (eradication rates of individual pathogens)
Time frame: 7-28 days
Defervescence (defined as Tmax orally or rectally)
Time frame: 7-28 days
Time to defervescence
Time frame: 7-28 days
Resolution of neutropenia (return of ANC to >500 cells/mm3)
Time frame: 7-28 days
Time to resolution of neutropenia
Time frame: 7-28 days
Mortality rate (survival at 7 days after the end of therapy)
Time frame: 7-28 days
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 1 Dec 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Febrile Neutropenia
RecruitingPhase 4
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
Febrile Neutropenia
Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
Breast Cancer, Chemotherapy-induced Neutropenia
Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
Oncopediatrics, Febrile Neutropenia
Recruiting
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Pediatric Oncology Patients With Risk for Infections
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.
Pfizer CT.gov Call Center study director
Pfizer
40 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing linezolid and vancomycin in people with Febrile Neutropenia, run by Pfizer at 40 sites in 11 countries.
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 2 inclusion and 2 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 1 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Brazil, Argentina, Colombia, Mexico and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical efficacy of linezolid when administered intravenously as compared to intravenously administered vancomycin in the empiric treatment of oncology patients with febrile neutropenia with suspected gram-positive infections. (time frame: 7-28 days). 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 1 Dec 2009.