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

Primary Purpose

Infection

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
teicoplanin
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infection focused on measuring infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady's Hospital for Sick Children Crumlin
  • Birmingham Children's Hospital
  • Bristol Royal Hospital for Children
  • Addenbrooke's Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Leicester Royal Infirmary
  • Royal Liverpool Children's Hospital, Alder Hey
  • Saint Bartholomew's Hospital
  • Great Ormond Street Hospital for Children
  • University College of London Hospitals
  • Royal Manchester Children's Hospital
  • Newcastle Upon Tyne Hospitals NHS Trust
  • Queen's Medical Centre
  • Oxford Radcliffe Hospital
  • Children's Hospital - Sheffield
  • Southampton General Hospital
  • Royal Marsden - Surrey
  • Royal Belfast Hospital for Sick Children
  • Aberdeen Royal Infirmary
  • Royal Hospital for Sick Children
  • Royal Hospital for Sick Children

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
August 6, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00024453
Brief Title
Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter
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 Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 1999 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
1360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
teicoplanin

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Pizer, MD
Organizational Affiliation
Royal Liverpool Children's Hospital, Alder Hey
Official's Role
Study Chair
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children Crumlin
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Children
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals NHS Trust
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom

12. IPD Sharing Statement

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

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