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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01817075
Recruitment Status : Completed
First Posted : March 22, 2013
Results First Posted : April 8, 2020
Last Update Posted : June 22, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bacterial Infection Benign Neoplasm Malignant Neoplasm Methicillin-Resistant Staphylococcus Aureus Infection Myeloid Neoplasm Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Procedure: Chlorhexidine Gluconate Skin Cleanser Other: Laboratory Biomarker Analysis Procedure: Mild Soap Skin Cleanser Other: Questionnaire Administration Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : November 4, 2013
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (CHG cleansing wipe)
Patients receive CHG cleansing with topical skin wipes QD for 90 days.
 Procedure: Chlorhexidine Gluconate Skin Cleanser
Given CHG cleansing
Other Name: Skin Cleanser with Chlorhexidine Gluconate

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies
Active Comparator: Arm II (control)
Patients receive control cleansing with topical skin wipes QD for 90 days.
 Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Mild Soap Skin Cleanser
Given control cleansing
Other Name: Skin Cleanser with Mild Soap

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days [ Time Frame: Up to 90 days post enrollment date ]
    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.


Secondary Outcome Measures :
  1. Percentage of Patients With Multi-drug Resistant Organisms (MDRO) [ Time Frame: Up to 90 days post enrollment date ]
    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.

  2. Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG) [ Time Frame: Up to 90 days post enrollment date ]
    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.

  3. Rate of Bacteremia Per 1000 At-risk Days [ Time Frame: Up to 90 days post enrollment date ]
    A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place.


Eligibility Criteria
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Ages Eligible for Study:   2 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817075


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Danielle M Zerr Children's Oncology Group
  Study Documents (Full-Text)

Documents provided by Children's Oncology Group:
Study Protocol and Statistical Analysis Plan  [PDF] September 24, 2014

More Information
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Additional Information:

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01817075    
Other Study ID Numbers: ACCL1034
NCI-2013-00595 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACCL1034 ( Other Identifier: Childrens Oncology Group )
COG-ACCL1034 ( Other Identifier: DCP )
ACCL1034 ( Other Identifier: CTEP )
R01CA163394 ( U.S. NIH Grant/Contract )
U10CA095861 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2013    Key Record Dates
Results First Posted: April 8, 2020
Last Update Posted: June 22, 2021
Last Verified: March 2020
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Sepsis
Staphylococcal Infections
Leukemia
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bacterial Infections and Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Gram-Positive Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents