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OpenTrials
Completed

NCT Number: NCT00035425

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

This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).

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Key information

Conditions

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

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Linezolid

Drug

600mg every 12 hours

Other names: Zyvox

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.

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.

    Time frame: 7-28 days

Secondary outcomes

  1. Microbiologic outcome

    Time frame: 7-28 days

  2. Pathogen eradication (eradication rates of individual pathogens)

    Time frame: 7-28 days

  3. Defervescence (defined as Tmax orally or rectally)

    Time frame: 7-28 days

  4. Time to defervescence

    Time frame: 7-28 days

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

    Time frame: 7-28 days

  6. Time to resolution of neutropenia

    Time frame: 7-28 days

  7. Mortality rate (survival at 7 days after the end of therapy)

    Time frame: 7-28 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Randomized, Double-Blind Trial Comparing Linezolid To Vancomycin In The Empiric Treatment Of Febrile Neutropenic Oncology Patients With Suspected Gram-Positive Infections

Important dates

Study start
2001
Study completion
2002
First posted
May 6, 2002
Registry last updated
Dec 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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