Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: Impact of Cleansing With Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-drug Resistant Organisms (MDRO) in Children With Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT)
Study ID: NCT01817075
Study Description
Brief Summary: This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control 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. Chlorhexidine gluconate may help reduce bloodstream infections and bacterial infections associated with the central line.
Detailed Description: PRIMARY OBJECTIVES: I. 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). SECONDARY OBJECTIVES: I. 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. II. 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. III. To determine whether CHG cleansing decreases positive blood cultures in children with cancer or those receiving allogeneic HCT. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive CHG cleansing with topical skin wipes once daily (QD) for 90 days. ARM II: Patients receive control cleansing with topical skin wipes QD for 90 days.
Keywords
Eligibility
Minimum Age: 2 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Valley Children's Hospital, Madera, California, United States
Children's Hospital and Research Center at Oakland, Oakland, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Medical Center-Parnassus, San Francisco, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States
Nemours Children's Hospital, Orlando, Florida, United States
Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Tampa General Hospital, Tampa, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
University of Illinois, Chicago, Illinois, United States
Children's Hospital New Orleans, New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
New York Medical College, Valhalla, New York, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio, United States
Legacy Emanuel Children's Hospital, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
T C Thompson Children's Hospital, Chattanooga, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Children's Hospital of San Antonio, San Antonio, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Children's Hospital, London, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada
San Jorge Children's Hospital, San Juan, , Puerto Rico
University Pediatric Hospital, San Juan, , Puerto Rico
Contact Details
Name: Danielle M Zerr
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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