Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003805
• Other study ID #: EORTC-46971
• Secondary ID: EORTC-46971
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 20, 2012
• Start date: November 1997

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients.

PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 859
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bone Marrow Suppression
• Fever
• Fever, Sweats, and Hot Flashes
• Hot Flashes
• Infection
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Neoplasms, Plasma Cell
• Pancytopenia
• Plasmacytoma
• Preleukemia
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Drug:
• piperacillin sodium

• piperacillin-tazobactam

• tazobactam sodium

• vancomycin

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Brussels (Bruxelles)
Belgium	Institut Jules Bordet	Brussels (Bruxelles)
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario
Czech Republic	Masaryk University Hospital	Brno
Finland	Turku University Central Hospital	Turku
France	CHR de Besancon - Hopital Saint-Jacques	Besancon
Germany	Klinikum der Universitaet Ulm	Ulm
Greece	Athens University-Laikon General Hospital	Athens
Greece	Hellenic Institute for Cancer-Saint Savas Hospital	Athens
Greece	Metaxa's Memorial Cancer Hospital	Piraeus
Greece	University of Patras Medical School	Rio Patras
Israel	Wolfson Medical Center	Holon
Israel	Hadassah University Hospital	Jerusalem
Israel	Chaim Sheba Medical Center	Ramat-Gan
Slovakia	National Cancer Institute - Bratislava	Bratislava
Slovakia	St. Elizabeth Cancer Institute Hospital	Bratislava
Switzerland	Ospedale San Giovanni	Bellinzona
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Universitaetsspital	Zurich
Turkey	Ibn-i Sina Hospital, Ankara Univeristy	Ankara
Turkey	Section of Infectious Diseases	Ankara
Turkey	Marmara University Hospital	Istanbul
United Kingdom	Royal Marsden Hospital	Sutton	England
United States	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Finland,  France,  Germany,  Greece,  Israel,  Slovakia,  Switzerland,  Turkey,  United Kingdom,