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)

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

Sponsors

Lead sponsor: Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Source Children's Oncology Group
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.

Overall Status Completed
Start Date November 4, 2013
Completion Date March 31, 2020
Primary Completion Date March 31, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days Up to 90 days post enrollment date
Secondary Outcome
Measure Time Frame
Percentage of Patients With Multi-drug Resistant Organisms (MDRO) Up to 90 days post enrollment date
Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG) Up to 90 days post enrollment date
Rate of Bacteremia Per 1000 At-risk Days Up to 90 days post enrollment date
Enrollment 177
Condition
Intervention

Intervention type: Procedure

Intervention name: Chlorhexidine Gluconate Skin Cleanser

Description: Given CHG cleansing

Arm group label: Arm I (CHG cleansing wipe)

Other name: Skin Cleanser with Chlorhexidine Gluconate

Intervention type: Other

Intervention name: Laboratory Biomarker Analysis

Description: Correlative studies

Intervention type: Procedure

Intervention name: Mild Soap Skin Cleanser

Description: Given control cleansing

Arm group label: Arm II (control)

Other name: Skin Cleanser with Mild Soap

Intervention type: Other

Intervention name: Questionnaire Administration

Description: Ancillary studies

Eligibility

Criteria:

Inclusion Criteria:

- TRANSPLANT PATIENTS: all patients undergoing planned allogeneic transplant (both malignant and non-malignant diagnoses)

- 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 a previous or current line infection are ineligible until 14 days after the completion of antibiotics

- 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

Gender: All

Minimum age: 2 Months

Maximum age: 21 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Danielle M Zerr Principal Investigator Children's Oncology Group
Location
facility
City of Hope Comprehensive Cancer Center | Duarte, California, 91010, United States
Miller Children's and Women's Hospital Long Beach | Long Beach, California, 90806, United States
Children's Hospital Los Angeles | Los Angeles, California, 90027, United States
Valley Children's Hospital | Madera, California, 93636, United States
Children's Hospital and Research Center at Oakland | Oakland, California, 94609-1809, United States
Children's Hospital of Orange County | Orange, California, 92868, United States
UCSF Medical Center-Parnassus | San Francisco, California, 94143, United States
UCSF Medical Center-Mission Bay | San Francisco, California, 94158, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance, California, 90502, United States
Connecticut Children's Medical Center | Hartford, Connecticut, 06106, United States
Yale University | New Haven, Connecticut, 06520, United States
Alfred I duPont Hospital for Children | Wilmington, Delaware, 19803, United States
Children's National Medical Center | Washington, District of Columbia, 20010, United States
Nemours Children's Clinic-Jacksonville | Jacksonville, Florida, 32207, United States
Nemours Children's Hospital | Orlando, Florida, 32827, United States
Nemours Children's Clinic - Pensacola | Pensacola, Florida, 32504, United States
Johns Hopkins All Children's Hospital | Saint Petersburg, Florida, 33701, United States
Tampa General Hospital | Tampa, Florida, 33606, United States
Children's Healthcare of Atlanta - Egleston | Atlanta, Georgia, 30322, United States
University of Illinois | Chicago, Illinois, 60612, United States
Children's Hospital New Orleans | New Orleans, Louisiana, 70118, United States
Ochsner Medical Center Jefferson | New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center | Bangor, Maine, 04401, United States
Sinai Hospital of Baltimore | Baltimore, Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore, Maryland, 21287, United States
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States
Wayne State University/Karmanos Cancer Institute | Detroit, Michigan, 48201, United States
Children's Mercy Hospitals and Clinics | Kansas City, Missouri, 64108, United States
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States
Montefiore Medical Center - Moses Campus | Bronx, New York, 10467, United States
The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park, New York, 11040, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York, New York, 10032, United States
New York Medical College | Valhalla, New York, 10595, United States
Wake Forest University Health Sciences | Winston-Salem, North Carolina, 27157, United States
The Toledo Hospital/Toledo Children's Hospital | Toledo, Ohio, 43606, United States
Legacy Emanuel Children's Hospital | Portland, Oregon, 97227, United States
Oregon Health and Science University | Portland, Oregon, 97239, United States
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota, 57117-5134, United States
T C Thompson Children's Hospital | Chattanooga, Tennessee, 37403, United States
St. Jude Children's Research Hospital | Memphis, Tennessee, 38105, United States
Vanderbilt University/Ingram Cancer Center | Nashville, Tennessee, 37232, United States
Dell Children's Medical Center of Central Texas | Austin, Texas, 78723, United States
Driscoll Children's Hospital | Corpus Christi, Texas, 78411, United States
Cook Children's Medical Center | Fort Worth, Texas, 76104, United States
Children's Hospital of San Antonio | San Antonio, Texas, 78207, United States
Methodist Children's Hospital of South Texas | San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio | San Antonio, Texas, 78229, United States
Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia, 23298, United States
Seattle Children's Hospital | Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington, 99204, United States
Madigan Army Medical Center | Tacoma, Washington, 98431, United States
Saint Vincent Hospital Cancer Center Green Bay | Green Bay, Wisconsin, 54301, United States
Children's Hospital | London, Ontario, N6A 5W9, Canada
Children's Hospital of Eastern Ontario | Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children | Toronto, Ontario, M5G 1X8, Canada
The Montreal Children's Hospital of the MUHC | Montreal, Quebec, H3H 1P3, Canada
San Jorge Children's Hospital | San Juan, 00912, Puerto Rico
University Pediatric Hospital | San Juan, 00926, Puerto Rico
Location Countries

Canada

Puerto Rico

United States

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Arm I (CHG cleansing wipe)

Arm group type: Experimental

Description: Patients receive CHG cleansing with topical skin wipes QD for 90 days.

Arm group label: Arm II (control)

Arm group type: Active Comparator

Description: Patients receive control cleansing with topical skin wipes QD for 90 days.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov