Teicoplanin in Treating Septicemia in Patients Who Are Receiving Chemotherapy Through a Central Venous Catheter - Full Text View

Sponsor:	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
Infection	Biological: teicoplanin

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control 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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis

Drug Information available for: Teicoplanin

U.S. FDA Resources

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

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000068944, CCLG-SC-1999-01, EU-20124
Study First Received:	September 13, 2001
Last Updated:	July 10, 2009
ClinicalTrials.gov Identifier:	NCT00024453 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

infection

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Anti-Bacterial Agents
Sepsis
Teicoplanin

Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on March 18, 2010