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

NCT00035425 | Completed Phase 3

• 2 other identifiers: M12600079A5951059
• Study Type: interventional
• Target: 120
• Locations: 10 countries
• Sites: 39

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).

Conditions

Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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.

  7-28 days

Secondary Outcomes (7)

• Microbiologic outcome

  7-28 days

• Pathogen eradication (eradication rates of individual pathogens)

  7-28 days

• Defervescence (defined as Tmax orally or rectally)

  7-28 days

• Time to defervescence

  7-28 days

• Resolution of neutropenia (return of ANC to >500 cells/mm3)

  7-28 days

Study Arms (2)

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.

Drug: linezolid

B.

EXPERIMENTAL

Drug: vancomycin

Interventions

linezolid DRUG

600mg every 12 hours

Also known as: Zyvox

A.

vancomycin DRUG

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.

B.

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (40)

Pfizer Investigational Site

Los Angeles, California, 90033, United States

Location

Pfizer Investigational Site

Springfield, Illinois, 62701-1014, United States

Location

Pfizer Investigational Site

Springfield, Illinois, 62703, United States

Location

Pfizer Investigational Site

Springfield, Illinois, 62769, United States

Location

Pfizer Investigational Site

Springfield, Illinois, 62781, United States

Location

Pfizer Investigational Site

The Bronx, New York, 10461, United States

Location

Pfizer Investigational Site

The Bronx, New York, 10467, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23226, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23229, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23249, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23294-4367, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23294, United States

Location

Pfizer Investigational Site

Federal Way, Washington, 98003, United States

Location

Pfizer Investigational Site

Lakewood, Washington, 98499, United States

Location

Pfizer Investigational Site

Tacoma, Washington, 98405, United States

Location

Pfizer Investigational Site

Buenos Aires, 1094, Argentina

Location

Pfizer Investigational Site

Córdoba, 5000, Argentina

Location

Pfizer Investigational Site

Mendoza, 5500, Argentina

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01409-902, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01509-900, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04024-002, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 05651-901, Brazil

Location

Pfizer Investigational Site

Santiago, Chile

Location

Pfizer Investigational Site

Bogotá, Bogota. DC, NAP, Colombia

Location

Pfizer Investigational Site

Bogotá, Bogota. DC, Colombia

Location

Pfizer Investigational Site

Medellín, Colombia

Location

Pfizer Investigational Site

Helsinki, FIN-00029 HYKS, Finland

Location

Pfizer Investigational Site

Zapopan, Jalisco, 45173, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, C.P. 64000, Mexico

Location

Pfizer Investigational Site

Mexico City, C.P. 02990, Mexico

Location

Pfizer Investigational Site

Lahore, Punjab Province, Pakistan

Location

Pfizer Investigational Site

Karachi, 74800, Pakistan

Location

Pfizer Investigational Site

Lima, Lima Province, 13, Peru

Location

Pfizer Investigational Site

Lima, Lima Province, 34, Peru

Location

Pfizer Investigational Site

Caracas, Distrito Federal, 1041, Venezuela

Location

Pfizer Investigational Site

Caracas, 1020, Venezuela

Location

Pfizer Investigational Site

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

Linezolid; Vancomycin

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2002
• First Posted: May 6, 2002
• Study Start: November 1, 2001
• Study Completion: November 1, 2002
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

US (16); CL (1); ME (3); PE (2); PA (2); CO (3); AR (3); BR (6); FI (1); VE (2)