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.
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
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Bacterial Infection
Benign Neoplasm
Malignant Neoplasm
Methicillin-Resistant Staphylococcus Aureus Infection
Myeloid Neoplasm
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
21 Years
Minimum Age
2 Months
NCT Id
NCT01817075
Org Class
Network
Org Full Name
Children's Oncology Group
Org Study Id
ACCL1034
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
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.
Outcome Measure
Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days
Outcome Time Frame
Up to 90 days post enrollment date
Secondary Ids
Secondary Id
NCI-2013-00595
Secondary Id
ACCL1034
Secondary Id
COG-ACCL1034
Secondary Id
ACCL1034
Secondary Id
R01CA163394
Secondary Id
U10CA095861
Secondary Id
UG1CA189955
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 90 days post enrollment date
Outcome Measure
Percentage of Patients With Multi-drug Resistant Organisms (MDRO)
Outcome Description
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.
Outcome Time Frame
Up to 90 days post enrollment date
Outcome Measure
Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG)
Outcome Description
A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place.
Outcome Time Frame
Up to 90 days post enrollment date
Outcome Measure
Rate of Bacteremia Per 1000 At-risk Days
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
21
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Gill
Investigator Email
jgill@montefiore.org
Investigator Phone
718-741-2331
Categories Mesh Debug
Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
Blood & Bone Marrow Cancers --- LEUKEMIA, LYMPHOID
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
BACTERIAL INFECTIONS
NEOPLASMS
PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
BACTERIAL INFECTIONS AND MYCOSES
INFECTIONS
LEUKEMIA, LYMPHOID
LEUKEMIA
NEOPLASMS BY HISTOLOGIC TYPE
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
CHLORHEXIDINE GLUCONATE