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Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection

Primary Purpose

Febrile Neutropenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
linezolid
vancomycin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Febrile Neutropenia

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A.

B.

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Microbiologic outcome
Pathogen eradication (eradication rates of individual pathogens)
Defervescence (defined as Tmax orally or rectally)
Time to defervescence
Resolution of neutropenia (return of ANC to >500 cells/mm3)
Time to resolution of neutropenia
Mortality rate (survival at 7 days after the end of therapy)

Full Information

First Posted
May 3, 2002
Last Updated
November 30, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00035425
Brief Title
Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Neutropenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A.
Arm Type
Experimental
Arm Description
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.
Arm Title
B.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
linezolid
Other Intervention Name(s)
Zyvox
Intervention Description
600mg every 12 hours
Intervention Type
Drug
Intervention Name(s)
vancomycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Microbiologic outcome
Time Frame
7-28 days
Title
Pathogen eradication (eradication rates of individual pathogens)
Time Frame
7-28 days
Title
Defervescence (defined as Tmax orally or rectally)
Time Frame
7-28 days
Title
Time to defervescence
Time Frame
7-28 days
Title
Resolution of neutropenia (return of ANC to >500 cells/mm3)
Time Frame
7-28 days
Title
Time to resolution of neutropenia
Time Frame
7-28 days
Title
Mortality rate (survival at 7 days after the end of therapy)
Time Frame
7-28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701-1014
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294-4367
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Pfizer Investigational Site
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Pfizer Investigational Site
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Pfizer Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1094
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01409-902
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
ZIP/Postal Code
05651-901
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Bogota. DC
ZIP/Postal Code
NAP
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Bogota. DC
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Medellin
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
FIN-00029 HYKS
Country
Finland
Facility Name
Pfizer Investigational Site
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45173
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
C.P. 64000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico D.f.
ZIP/Postal Code
C.P. 02990
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Pfizer Investigational Site
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
13
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Distrito Federal
ZIP/Postal Code
1041
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
ZIP/Postal Code
1020
Country
Venezuela
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=M12600079&StudyName=Treatment%20of%20Neutropenic%20Patients%20With%20Fever%20Who%20Are%20Suspected%20to%20Have%20A%20Gram%20Positive%20Infection%20
Description
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Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection

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