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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: Children's Cancer and Leukaemia Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024453
  Purpose

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 Intervention
Cancer-Related Problem/Condition
Drug: teicoplanin

MedlinePlus related topics:   Antibiotics    Cancer    Sepsis   

Drug Information available for:   Teicoplanin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   1360
Study Start Date:   February 1999
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024453

Locations
Ireland
Our Lady's Hospital for Sick Children Crumlin     Recruiting
      Dublin, Ireland, 12
      Contact: Fin Breatnach, MD, FRCPE     353-1-409-6659     fin.breatnach@olhsc.ie    
United Kingdom, England
Addenbrooke's Hospital     Recruiting
      Cambridge, England, United Kingdom, CB2 2QQ
      Contact: Denise Williams, MD     44-1223-216-878        
Birmingham Children's Hospital     Recruiting
      Birmingham, England, United Kingdom, B4 6NH
      Contact: Bruce Morland, MD     44-121-333-8233     bruce.morland@bch.nhs.uk    
Bristol Royal Hospital for Children     Recruiting
      Bristol, England, United Kingdom, BS2 8BJ
      Contact: Annabel B.M. Foot     44-117-342-8520        
Children's Hospital - Sheffield     Recruiting
      Sheffield, England, United Kingdom, S10 2TH
      Contact: Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH     44-114-271-7366     mary.gerrard@sch.nhs.uk    
Oxford Radcliffe Hospital     Recruiting
      Oxford, England, United Kingdom, 0X3 9DU
      Contact: Kate Wheeler, MD     44-186-522-1066        
Leeds Cancer Centre at St. James's University Hospital     Recruiting
      Leeds, England, United Kingdom, LS9 7TF
      Contact: Adam Glaser, MD     44-113-206-4984     adam.glaser@leedsth.nhs.uk    
Leicester Royal Infirmary     Recruiting
      Leicester, England, United Kingdom, LE1 5WW
      Contact: Rosemary S. Shannon, MD     44-116-254-1414        
Newcastle Upon Tyne Hospitals NHS Trust     Recruiting
      Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
      Contact: Andrew David J. Pearson, MD, FRCP, DCh     44-191-232-5131 ext. 24101        
Great Ormond Street Hospital for Children     Recruiting
      London, England, United Kingdom, WC1N 3JH
      Contact: Penelope Brock, MD, PhD     44-20-829-8832     Brockp@gosh.nhs.uk    
Queen's Medical Centre     Recruiting
      Nottingham, England, United Kingdom, NG7 2UH
      Contact: David A. Walker     44-115-924-9924     david.walker@nottingham.ac.uk    
Royal Liverpool Children's Hospital, Alder Hey     Recruiting
      Liverpool, England, United Kingdom, L12 2AP
      Contact: Heather P. McDowell, MD     44-151-293-3679        
Royal Manchester Children's Hospital     Recruiting
      Manchester, England, United Kingdom, M27 4HA
      Contact: Bernadette Brennan, MD     44-161-922-2227     bernadette.brennan@cmmc.nhs.uk    
Royal Marsden - Surrey     Recruiting
      Sutton, England, United Kingdom, SM2 5PT
      Contact: Kathy Pritchard-Jones, MD     44-20-8661-3498        
Saint Bartholomew's Hospital     Recruiting
      London, England, United Kingdom, EC1A 7BE
      Contact: Judith E. Kingston, MD     44-20-7943-1339     j.e.kingston@qmul.ac.uk    
Southampton General Hospital     Recruiting
      Southampton, England, United Kingdom, SO16 6YD
      Contact: Janice A. Kohler, MD, FRCP     44-23-8079-6942        
University College of London Hospitals     Recruiting
      London, England, United Kingdom, WIT 3AA
      Contact: Maria Michelagnoli, MD     44-20-7380-9950     maria.michelagnoli@uclh.org    
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children     Recruiting
      Belfast, Northern Ireland, United Kingdom, BT12 6BE
      Contact: Anthony McCarthy, MD     44-289-063-3631     anthonymcarthy@royalhospital.n.i.nhs.uk    
United Kingdom, Scotland
Aberdeen Royal Infirmary     Recruiting
      Aberdeen, Scotland, United Kingdom, AB25 2ZN
      Contact: D.J. King, MD     44-84-5456-6000     derek.king@arh.gampian.scot.nhs.uk    
Royal Hospital for Sick Children     Recruiting
      Glasgow, Scotland, United Kingdom, G3 8SJ
      Contact: E.M. Simpson     44-141-201-0000        
Royal Hospital for Sick Children     Recruiting
      Edinburgh, Scotland, United Kingdom, EH9 1LF
      Contact: W. Hamish Wallace, MD     44-131-536-0426        

Sponsors and Collaborators
Children's Cancer and Leukaemia Group

Investigators
Study Chair:     Barry Pizer, MD     Royal Liverpool Children's Hospital, Alder Hey    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068944, CCLG-SC-1999-01, EU-20124
First Received:   September 13, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00024453
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
infection  

Study placed in the following topic categories:
Coagulase
Systemic Inflammatory Response Syndrome
Sepsis
Teicoplanin
Inflammation

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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