DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Febrile Neutropenia

Intervention: linezolid (Drug); vancomycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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.

Secondary outcome:

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)

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Buenos Aires 1094, Argentina

Pfizer Investigational Site, Cordoba 5000, Argentina

Pfizer Investigational Site, Mendoza 5500, Argentina

Pfizer Investigational Site, São Paulo 04024-002, Brazil

Pfizer Investigational Site, São Paulo 05651-901, Brazil

Pfizer Investigational Site, Santiago, Chile

Pfizer Investigational Site, Medellin, Colombia

Pfizer Investigational Site, Helsinki FIN-00029 HYKS, Finland

Pfizer Investigational Site, Mexico D.f. C.P. 02990, Mexico

Pfizer Investigational Site, Karachi 74800, Pakistan

Pfizer Investigational Site, Lima 13, Peru

Pfizer Investigational Site, Lima 34, Peru

Pfizer Investigational Site, Caracas 1020, Venezuela

Pfizer Investigational Site, Bogota, Bogota. DC NAP, Colombia

Pfizer Investigational Site, Bogota, Bogota. DC, Colombia

Pfizer Investigational Site, Los Angeles, California 90033, United States

Pfizer Investigational Site, Unknown, Córdoba 5000, Argentina

Pfizer Investigational Site, Caracas, Distrito Federal 1041, Venezuela

Pfizer Investigational Site, Springfield, Illinois 62781, United States

Pfizer Investigational Site, Springfield, Illinois 62701-1014, United States

Pfizer Investigational Site, Springfield, Illinois 62703, United States

Pfizer Investigational Site, Springfield, Illinois 62769, United States

Pfizer Investigational Site, Zapopan, Jalisco 45173, Mexico

Pfizer Investigational Site, Bronx, New York 10461, United States

Pfizer Investigational Site, Bronx, New York 10467, United States

Pfizer Investigational Site, Monterrey, Nuevo Leon C.P. 64000, Mexico

Pfizer Investigational Site, Lahore, Punjab, Pakistan

Pfizer Investigational Site, Porto Alegre, RS 90020-090, Brazil

Pfizer Investigational Site, Porto Alegre, RS 90610-000, Brazil

Pfizer Investigational Site, Sao Paulo, SP 01509-900, Brazil

Pfizer Investigational Site, São Paulo, SP 01409-902, Brazil

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Richmond, Virginia 23226, United States

Pfizer Investigational Site, Richmond, Virginia 23229, United States

Pfizer Investigational Site, Richmond, Virginia 23249, United States

Pfizer Investigational Site, Richmond, Virginia 23294-4367, United States

Pfizer Investigational Site, Richmond, Virginia 23294, United States

Pfizer Investigational Site, Federal Way, Washington 98003, United States

Pfizer Investigational Site, Lakewood, Washington 98499, United States

Pfizer Investigational Site, Tacoma, Washington 98405, United States

Additional Information

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

Starting date: November 2001
Last updated: November 30, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017