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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01817075
First received: March 20, 2013
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Bacterial Infection
Malignant Neoplasm
Methicillin-resistant Staphylococcus Aureus Infection
Nonmalignant Neoplasm
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Drug: chlorhexidine gluconate
Procedure: wound care management
Other: questionnaire administration
Other: laboratory biomarker analysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Number of CLABSI (central line associated bloodstream infections) events during the at-risk days [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    Estimated and compared between the 2 arms by a Poisson regression model adjusting for the randomization stratification factor on treatment/diagnosis.


Secondary Outcome Measures:
  • Acquisition of MDRO (multidrug resistant organisms) [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    Compared between the two arms using logistic regression. Non-linear mixed effects models will also be used to examine the effect of CHG on the proportion of patients acquiring MDRO with adjustment for the treating institution as random effects.

  • Susceptibility to CHG as measured by minimum inhibitory concentrations and minimum bactericidal concentrations [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    Compared between the two arms using logistic regression. Nonlinear mixed models applied to explore the association between CHG cleansing and reduced susceptibility to CHG over the longitudinal assessments.

  • Number of bacteremia episodes during the at-risk days [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    Poisson regression model used for detecting the reduction in the rate of bacteremia at 2-sided alpha level of 0.05.


Other Outcome Measures:
  • Patient satisfaction survey [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to summarize the responses to the patient satisfaction survey collected at the end of the study. Counts/percentages of patients who consider the study cleansing easy/difficult to use and those of patients satisfied/unsatisfied with the cleansing cloths will be tabulated. The reasons provided for dissatisfaction will also be tabulated. These descriptive statistics will be generated for the entire study population across the 2 arms first and then by each arm.


Estimated Enrollment: 450
Study Start Date: November 2013
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (CHG cleansing wipe)
Patients receive CHG cleansing with topical skin wipes QD for 90 days.
Drug: chlorhexidine gluconate
Given CGH cleansing
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
Active Comparator: Arm II (control)
Patients receive control cleansing with topical skin wipes QD for 90 days.
Procedure: wound care management
Given control cleansing
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   2 Months to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817075

  Show 27 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Danielle Zerr, MD MPH Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01817075     History of Changes
Other Study ID Numbers: ACCL1034, NCI-2013-00595, COG-ACCL1034, ACCL1034, ACCL1034, ACCL1034, U10CA095861, UG1CA189955
Study First Received: March 20, 2013
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Infection
Staphylococcal Infections
Gram-Positive Bacterial Infections
Leukemia
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014