CCL1034: Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant

Category:

Supportive Infectious Diseases Studies

Diseases Treated:

Cancer or allogeneic hematopoietic cell transplantation

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients.

  • Participant > 2 months of age and < 21 years of age at enrollment.
  • Participant has or is scheduled to have an external tunneled central venous catheter (CVC) (Broviacs, Hickmans, tunneled percutaneously inserted central PICCs), that is expected to remain in place for an additional > 3 months.
  • Participant with a current or previous line infection completed antibiotics > 14 days ago.

Description

In this study, we want to see if using CHG cleansing cloths can help prevent central line associated bloodstream infections (CLA-BSIs). To test this we will give participants a cleansing cloth that either contains CHG or does not contain CHG and observe how well each one prevents CLA-BSI.

Preventing CLA-BSI is important for the following reasons:

  • CLA-BSI is one of the most common and serious infections.
  • Many patients with CLA-BSI need to have their central lines removed and/or replaced.

CHG cloths have been researched in adult population. These studies have shown that use of CHG, either in cloths or as a liquid wash, helped reduce the chances of getting CLA-BSIs in patients with central lines. These studies also showed that the use of CHG reduced the chance of getting bacteria (germs) resistant to multiple antibiotics. However, the use of CHG cloths is experimental in children and adolescents with cancer.

Objectives

  • To determine whether chlorhexidine gluconate (CHG) cleansing decreases central line associated bloodstream infection (CLABSI) in children with cancer or those receiving an allogeneic hematopoietic cell transplantation (HCT).
  • To determine whether CHG cleansing decreases acquisition of multi-drug resistant organisms [MDRO: vancomycin resistant enterococci (VRE), methicillin resistant Staphylococcus aureus (MRSA), etc.] in children with cancer or those receiving allogeneic HCT.
  • To determine whether CHG cleansing in children with cancer or those receiving allogeneic HCT is associated with cutaneous bacterial isolates with reduced susceptibility to CHG.
  • To determine whether CHG cleansing decreases positive blood cultures in children with cancer or those receiving allogeneic HCT.

Eligibility criteria, among others, include:

  • Participant > 2 months of age and < 21 years of age at enrollment.
  • Participant has or is scheduled to have an external tunneled central venous catheter (CVC) (Broviacs, Hickmans, tunneled percutaneously inserted central PICCs), that is expected to remain in place for an additional > 3 months.
  • Participant with a current or previous line infection completed antibiotics > 14 days ago.
  • Participant was not previously enrolled on this trial.
  • Participant is not a female who is pregnant or breastfeeding.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Principal Investigator

Gabriela Maria Marón Alfaro, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.