RATIONALE: Giving the antibiotic teicoplanin by infusion and allowing bacteria to be exposed to the antibiotic for a longer period of time may be effective in preventing or controlling septicemia.

PURPOSE: Randomized clinical trial to compare two different methods of giving teicoplanin in treating septicemia in patients who are receiving chemotherapy through a central venous catheter.

Condition	Treatment or Intervention
Infection	Drug: teicoplanin  Procedure: antibiotic therapy  Procedure: infection prophylaxis/management  Procedure: supportive care/therapy

Further Study Details: 

OBJECTIVES:

• Compare the response and cure rate of coagulase-negative staphylococcal septicemia in patients receiving chemotherapy through a central venous catheter treated with 2 different schedules of teicoplanin.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and number of central venous catheter lumens (1 vs 2). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive teicoplanin IV bolus every 12 hours for 3 doses and then once daily for 5 doses (total of 7 days).
• Arm II: Patients receive teicoplanin IV over 2 hours and/or by antibiotic lock every 12 hours for 3 doses and then once daily for 5 doses (total of 7 days).

PROJECTED ACCRUAL: Approximately 490-1,360 patients will be accrued for this study within 2.2-6.2 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Suspected septicemia caused by coagulase-negative staphylococci
• Single or double lumen (no triple lumen) central venous catheter (CVC) (including subcutaneous ports) that can be flushed and aspirated
• Expected to remain in situ for at least 8 weeks
• No coagulase-negative septicemia associated with existing CVC within the past 12 weeks
• Receiving chemotherapy for neoplastic condition, aplastic anemia, Fanconi's anemia, Langerhans' cell histiocytosis, or myelodysplasia

PATIENT CHARACTERISTICS: Age:

• 2 months and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine clearance at least 60 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Ireland
      Our Lady's Hospital for Sick Children, Crumlin,  12,  Ireland; Recruiting
United Kingdom, England
      Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge,  England,  CB2 2QQ,  United Kingdom; Recruiting
      Birmingham Children's Hospital, Birmingham,  England,  B4 6NH,  United Kingdom; Recruiting
      Bristol Royal Hospital for Children, Bristol,  England,  BS2 8BJ,  United Kingdom; Recruiting
      Central Manchester and Manchester Children's University Hospitals NHS Trust, Manchester,  England,  M27 4HA,  United Kingdom; Recruiting
      Children's Hospital - Sheffield, Sheffield,  England,  S10 2TH,  United Kingdom; Recruiting
      Great Ormond Street Hospital for Children NHS Trust, London,  England,  WC1N 3JH,  United Kingdom; Recruiting
      Leicester Royal Infirmary, Leicester,  England,  LE1 5WW,  United Kingdom; Recruiting
      Meyerstein Institute of Oncology at University College of London Hospitals, London,  England,  WIT 3AA,  United Kingdom; Recruiting
      Newcastle Upon Tyne Hospitals NHS Trust, Newcastle upon Tyne,  England,  NE7 7DN,  United Kingdom; Recruiting
      Oxford Radcliffe Hospital, Oxford,  England,  0X3 9DU,  United Kingdom; Recruiting
      Queen's Medical Centre, Nottingham,  England,  NG7 2UH,  United Kingdom; Recruiting
      Royal Liverpool Children's Hospital, Alder Hey, Liverpool,  England,  L12 2AP,  United Kingdom; Recruiting
      Royal Marsden NHS Foundation Trust - Surrey, Sutton,  England,  SM2 5PT,  United Kingdom; Recruiting
      Saint Bartholomew's Hospital, London,  England,  EC1A 7BE,  United Kingdom; Recruiting
      Southampton General Hospital, Southampton,  England,  SO16 6YD,  United Kingdom; Recruiting
      St. James's University Hospital at Leeds Teaching Hospital NHS Trust, Leeds,  England,  LS9 7TF,  United Kingdom; Recruiting
United Kingdom, Northern Ireland
      Royal Belfast Hospital for Sick Children, Belfast,  Northern Ireland,  BT12 6BE,  United Kingdom; Recruiting
United Kingdom, Scotland
      Aberdeen Royal Infirmary, Aberdeen,  Scotland,  AB25 2ZN,  United Kingdom; Recruiting
      Royal Hospital for Sick Children, Glasgow,  Scotland,  G3 8SJ,  United Kingdom; Recruiting
      Royal Hospital for Sick Children, Edinburgh,  Scotland,  United Kingdom; Recruiting

Study chairs or principal investigators

Barry Pizer, MD,  Study Chair,  Royal Liverpool Children's Hospital, Alder Hey   

Study ID Numbers:  CDR0000068944; UKCCSG-SC-1999-01; EU-20124
Record last reviewed:  February 2002
Last Updated:  April 4, 2005
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024453
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08