Clinical trial NCT00035425: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Febrile Neutropenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
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.
timeFrame: 7-28 days
Secondary outcomes:
measure: Microbiologic outcome
timeFrame: 7-28 days
measure: Pathogen eradication (eradication rates of individual pathogens)
timeFrame: 7-28 days
measure: Defervescence (defined as Tmax orally or rectally)
timeFrame: 7-28 days
measure: Time to defervescence
timeFrame: 7-28 days
measure: Resolution of neutropenia (return of ANC to >500 cells/mm3)
timeFrame: 7-28 days
measure: Time to resolution of neutropenia
timeFrame: 7-28 days
measure: Mortality rate (survival at 7 days after the end of therapy)
timeFrame: 7-28 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Federal Way
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Mendoza
country: Argentina
facility: Pfizer Investigational Site
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Bogota. DC
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Bogota. DC
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Mexico D.f.
country: Mexico
facility: Pfizer Investigational Site
city: Lahore
country: Pakistan
facility: Pfizer Investigational Site
state: Punjab
city: Karachi
country: Pakistan
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Distrito Federal
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: