Malignant Neoplasm Clinical Trial
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)
Verified date | March 2020 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 177 |
Est. completion date | March 31, 2020 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Children's Hospital | London | Ontario |
Canada | The Montreal Children's Hospital of the MUHC | Montreal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | Hospital for Sick Children | Toronto | Ontario |
Puerto Rico | San Jorge Children's Hospital | San Juan | |
Puerto Rico | University Pediatric Hospital | San Juan | |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | T C Thompson Children's Hospital | Chattanooga | Tennessee |
United States | University of Illinois | Chicago | Illinois |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
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 | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York |
United States | Children's Hospital New Orleans | New Orleans | Louisiana |
United States | Ochsner Medical Center Jefferson | New Orleans | Louisiana |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Children's Hospital and Research Center at Oakland | Oakland | California |
United States | Children's Hospital of Orange County | Orange | California |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Nemours Children's Clinic - Pensacola | Pensacola | Florida |
United States | Legacy Emanuel Children's Hospital | Portland | Oregon |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
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 | UCSF Medical Center-Mission Bay | San Francisco | California |
United States | UCSF Medical Center-Parnassus | San Francisco | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Tampa General Hospital | Tampa | Florida |
United States | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio |
United States | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days | Rate of CLABSI per 1000 at-risk days. CLABSI outcome is defined according to the January 2015 Centers for Disease Control and Prevention (CDC) criteria. At risk days are defined as days with eligible central lines in place. | Up to 90 days post enrollment date | |
Secondary | Percentage of Patients With Multi-drug Resistant Organisms (MDRO) | MDROs are defined as Staphylococcus aureus resistant to oxacillin, Enterococcus spp. resistant to vancomycin, Klebsiella pneumoniae or Escherichia coli non-susceptible (intermediate or resistant) to ceftriaxone, ceftazidime, cefepime or any carbapenem, and Pseudomonas aeruginosa or Acinetobacter baumannii resistant to any carbapenem or ceftazidime, and either an aminoglycoside or fluoroquinolone. Clostridium difficile infection (CDI) is included as an MDRO and is defined as a positive lab test for C. difficile and > 3 unformed stools in < 24 hours. | Up to 90 days post enrollment date | |
Secondary | Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG) | Susceptibility to CHG is defined by MIC cutoff that is cutaneous staphylococcal isolate isolated from a follow-up swab with CHG MIC > 4 ug/mL in patient without a resistant staphylococcal isolate isolated from a baseline swab. | Up to 90 days post enrollment date | |
Secondary | Rate of Bacteremia Per 1000 At-risk Days | A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place. | Up to 90 days post enrollment date |
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