Completed

Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given Piperacillin/Tazobactam

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

piperacillin sodium

+ piperacillin-tazobactam

+ tazobactam sodium

Drug
Who is being recruted

Blood Protein Disorders+63

+ Body Temperature Changes

+ Bone Marrow Diseases

Over 2 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 3
Interventional
Study Start: November 1997
See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: September 24, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Compare the efficacy of piperacillin and tazobactam with or without vancomycin in reducing fever in patients with hematological malignancies and persistent febrile granulocytopenia. OUTLINE: This is a randomized, double blind, multicenter study. Patients receive piperacillin/tazobactam IV over 20-30 minutes every 6 hours. Patients who become afebrile within 48-60 hours after beginning treatment continue to receive piperacillin/tazobactam alone. These afebrile patients continue treatment for a minimum of 7 days, of which 4 must be consecutive without fever. Patients who are still febrile after the initial 48-60 hours are randomized to continue on piperacillin/tazobactam alone or with vancomycin. Vancomycin IV is administered over at least 1 hour twice daily. Treatment continues for a maximum of 28 days in the absence of persistent fever. Patients are followed at 7-10 days after completion of therapy. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

NCT00003805
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: September 24, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

859 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 2 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersBody Temperature ChangesBone Marrow DiseasesCardiovascular DiseasesCell Transformation, NeoplasticChronic DiseaseDNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplastic ProcessesParaproteinemiasPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsTumor Virus InfectionsVascular DiseasesVirus DiseasesLeukemia, B-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveHistiocytosisHistiocytic Disorders, MalignantLymphoma, B-CellLymphoma, T-CellEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesCarcinogenesisBlast CrisisBurkitt LymphomaFeverHodgkin DiseaseInfectionsLeukemiaLeukemia, Hairy CellLymphomaLymphoma, FollicularLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaMultiple MyelomaMyelodysplastic SyndromesRecurrenceLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, B-Cell, Marginal ZoneHot FlashesLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma CellDendritic Cell Sarcoma, Interdigitating

Criteria

DISEASE CHARACTERISTICS: Leukemia, lymphoma, or Hodgkin's disease OR Stem cell transplantation or bone marrow transplantation (allogenic or autologous) for a neoplastic disease Absolute granulocyte count no greater than 1,000/mm3 anticipated to fall below 500/mm3 within 24-48 hours, and expected to last for longer than 7 days from onset of fever Fever (i.e., oral or axillary temperature at least 38.5 degrees C or 101.3 degrees F once, or at least 38 degrees C or 100.4 degrees F on two or more occasions separated at least by 1 hour during a 12 hour period) Presumed infection PATIENT CHARACTERISTICS: Age: 2 and over Performance status: Not moribund or comatose for any reason with little hope of recovery Life expectancy: At least 48 hours Hematopoietic: See Disease Characteristics Hepatic: No hepatic stupor or coma Renal: Adults: No renal failure requiring hemodialysis or peritoneal dialysis OR Creatinine no greater than 2.25 mg/dL OR Creatinine clearance at least 40 mL/min Children: No renal impairment (i.e., creatinine greater than upper limit of normal) Pulmonary: No lung infiltrate Other: No known allergy to piperacillin, tazobactam, or vancomycin No history of immediate or accelerated reaction to beta-lactam antibiotics No prior inclusion in this study No catheter related infection No known HIV infection Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 days since prior intravenous antibacterial agents Oral antibiotics for prophylaxis of bacterial infection allowed At least 30 days since prior treatment with any other investigational antibiotic No other concurrent antibiotics except trimethoprim-sulfamethoxazole for the prevention of Pneumocystis carinii pneumonia

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 28 locations

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, United StatesOpen Marlene & Stewart Greenebaum Cancer Center, University of Maryland in Google Maps

Boston Medical Center

Boston, United States

Algemeen Ziekenhuis Middelheim

Antwerp, Belgium

Hopital Universitaire Erasme

Brussels, Belgium
Completed28 Study Centers