Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter

Sponsor
Children's Cancer and Leukaemia Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT00024453
Collaborator
(none)
1,360
21
64.8

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Biological: teicoplanin
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1360 participants
Allocation:
Randomized
Primary Purpose:
Supportive Care
Official Title:
The Use of Teicoplanin in the Treatment of Septicaemia Caused by Coagulase-Negative Staphylococci - A Randomized Study Comparing Bolus Injection With Infused and/or Line-Locked Teicoplanin
Study Start Date :
Feb 1, 1999
Anticipated Primary Completion Date :
Dec 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Our Lady's Hospital for Sick Children Crumlin Dublin Ireland 12
    2 Birmingham Children's Hospital Birmingham England United Kingdom B4 6NH
    3 Bristol Royal Hospital for Children Bristol England United Kingdom BS2 8BJ
    4 Addenbrooke's Hospital Cambridge England United Kingdom CB2 2QQ
    5 Leeds Cancer Centre at St. James's University Hospital Leeds England United Kingdom LS9 7TF
    6 Leicester Royal Infirmary Leicester England United Kingdom LE1 5WW
    7 Royal Liverpool Children's Hospital, Alder Hey Liverpool England United Kingdom L12 2AP
    8 Saint Bartholomew's Hospital London England United Kingdom EC1A 7BE
    9 Great Ormond Street Hospital for Children London England United Kingdom WC1N 3JH
    10 University College of London Hospitals London England United Kingdom WIT 3AA
    11 Royal Manchester Children's Hospital Manchester England United Kingdom M27 4HA
    12 Newcastle Upon Tyne Hospitals NHS Trust Newcastle-Upon-Tyne England United Kingdom NE7 7DN
    13 Queen's Medical Centre Nottingham England United Kingdom NG7 2UH
    14 Oxford Radcliffe Hospital Oxford England United Kingdom 0X3 9DU
    15 Children's Hospital - Sheffield Sheffield England United Kingdom S10 2TH
    16 Southampton General Hospital Southampton England United Kingdom SO16 6YD
    17 Royal Marsden - Surrey Sutton England United Kingdom SM2 5PT
    18 Royal Belfast Hospital for Sick Children Belfast Northern Ireland United Kingdom BT12 6BE
    19 Aberdeen Royal Infirmary Aberdeen Scotland United Kingdom AB25 2ZN
    20 Royal Hospital for Sick Children Edinburgh Scotland United Kingdom EH9 1LF
    21 Royal Hospital for Sick Children Glasgow Scotland United Kingdom G3 8SJ

    Sponsors and Collaborators

    • Children's Cancer and Leukaemia Group

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00024453
    Other Study ID Numbers:
    • CCLG-SC-1999-01
    • CDR0000068944
    • EU-20124
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Aug 7, 2013
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 7, 2013