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
NCT ID: NCT01817075
Last Updated: 2021-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
177 participants
INTERVENTIONAL
2013-11-04
2020-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I (CHG cleansing wipe)
Patients receive CHG cleansing with topical skin wipes QD for 90 days.
Chlorhexidine Gluconate Skin Cleanser
Given CHG cleansing
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Arm II (control)
Patients receive control cleansing with topical skin wipes QD for 90 days.
Laboratory Biomarker Analysis
Correlative studies
Mild Soap Skin Cleanser
Given control cleansing
Questionnaire Administration
Ancillary studies
Interventions
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Chlorhexidine Gluconate Skin Cleanser
Given CHG cleansing
Laboratory Biomarker Analysis
Correlative studies
Mild Soap Skin Cleanser
Given control cleansing
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ONCOLOGY PATIENTS: patients with an oncology diagnosis that are or will be on a chemotherapy regimen that will last for an additional \>= 3 months or are on or will be on a chemotherapy regimen for \< 3 months and then proceed to transplant (allogeneic or autologous stem cell rescue) during the 3-month study period
* Patients undergoing allogeneic transplant must have, or be scheduled to have, an external tunneled central venous catheter (CVC) (Broviacs, Hickmans, tunneled percutaneously inserted central catheter \[PICCs\], etc.) and/or non-tunneled percutaneously inserted central catheter (PICC) that is expected to remain in place for an additional \>= 3 months
* Patients with acute myelogenous leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL) that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) and/or non-tunneled PICC that is expected to remain in place for an additional \>= 3 months
* All other oncology patients that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) that is expected to remain in place for an additional \>= 3 months
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
* Patients with only totally implanted CVCs or ports are ineligible
* Patients with a known allergy or hypersensitivity to CHG are ineligible
* Patients with chronic, severe, generalized skin breakdown (such as generalized blistering, burns, severe graft versus host disease \[GVHD\] with open sores, etc.) are ineligible
* Patients currently enrolled on Children's Oncology Group (COG) study ACCL0934 are not eligible until they have completed the infection observation period of that study
* Patients scheduled to receive broad-spectrum prophylactic antibacterial therapy are ineligible; patients only receiving prophylaxis for Pneumocystis pneumonia (PCP) (trimethoprim \[TMP\]/sulfamethoxazole \[SMX\]) or encapsulated organisms (penicillin) are eligible
* Patients receiving sorafenib at the time of enrollment and those who are scheduled to receive sorafenib as part of a treatment plan are ineligible
* Patients using prophylactic antimicrobial locks in the CVC at the time of enrollment and those who are scheduled to receive antimicrobial locks in the CVC as part of a treatment plan are ineligible
* Patients previously enrolled on this trial are ineligible
* Females who are pregnant or breastfeeding are ineligible
2 Months
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Danielle M Zerr
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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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 D.C., 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
St. 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
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, 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
Montefiore Medical Center - Moses Campus
The Bronx, 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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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NCI-2013-00595
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACCL1034
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ACCL1034
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL1034
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL1034
Identifier Type: -
Identifier Source: org_study_id
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