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

This study is no longer recruiting patients.

Sponsored by: EORTC International Antimicrobial Therapy Group
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma
 Drug: piperacillin
 Drug: tazobactam
 Drug: vancomycin
Phase III

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma;   Multiple Myeloma

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Phase III Randomized Study of Piperacillin/Tazobactam With or Without Vancomycin in Cancer Patients with Persistently Febrile Granulocytopenia

Further Study Details: 

Study start: November 1997

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  2 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Location Information


Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States

Belgium
      Algemeen Ziekenhuis Middelheim, Antwerp,  2020,  Belgium

      Cliniques Universitaires Saint-Luc, Brussels (Bruxelles),  1200,  Belgium

      Hopital Universitaire Erasme, Brussels,  1070,  Belgium

      Institut Jules Bordet, Brussels (Bruxelles),  1000,  Belgium

Canada, Ontario
      Kingston General Hospital, Kingston,  Ontario,  K7L 2V7,  Canada

      Ottawa Regional Cancer Center - General Division, Ottawa,  Ontario,  K1H 8L6,  Canada

Czech Republic
      Masaryk University Hospital, Brno,  639 00,  Czech Republic

Finland
      Turku University Central Hospital, Turku,  FIN-2-0521,  Finland

France
      CHR de Besancon - Hopital Saint-Jacques, Besancon,  25030,  France

Germany
      Klinikum der Universitaet Ulm, Ulm,  D-89081,  Germany

Greece
      Athens University-Laikon General Hospital, Athens,  11527,  Greece

      Hellenic Institute for Cancer-Saint Savas Hospital, Athens,  11522,  Greece

      Metaxa's Memorial Cancer Hospital, Piraeus,  18537,  Greece

      University of Patras Medical School, Rio Patras,  GR-26500,  Greece

Israel
      Chaim Sheba Medical Center, RAMAT-GAN,  52621,  Israel

      Hadassah University Hospital, Jerusalem,  91120,  Israel

      Wolfson Medical Center, Holon,  58100,  Israel

Slovakia
      National Cancer Institute - Bratislava, Bratislava,  833 10,  Slovakia

      St. Elizabeth Cancer Institute Hospital, Bratislava,  SK-81250,  Slovakia

Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  CH-1011,  Switzerland

      Ospedale San Giovanni, Bellinzona,  CH-6500,  Switzerland

      Universitaetsspital, Zurich,  CH-8091,  Switzerland

Turkey
      Ibn-i Sina Hospital, Ankara Univeristy, Ankara,  06100,  Turkey

      Marmara University Hospital, Istanbul,  81190,  Turkey

      Section of Infectious Diseases, Ankara,  06100,  Turkey

United Kingdom, England
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom

Study chairs or principal investigators

Michel P. Glauser,  Study Chair,  EORTC International Antimicrobial Therapy Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066949; EORTC-46971
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003805
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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