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 - Full Text View

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 Benign Neoplasm Malignant Neoplasm Methicillin-Resistant Staphylococcus Aureus Infection Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Untreated Childhood Myeloid Neoplasm	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:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Bacterial Infections Cancer Wounds and Injuries

Drug Information available for: Chlorhexidine Chlorhexidine acetate Sodium gluconate Chlorhexidine hydrochloride Manganese gluconate Chlorhexidine gluconate Hibiclens

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia Lymphosarcoma

U.S. FDA Resources

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

Primary Outcome Measures:

Number of CLABSI 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 [ 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 Names: Wound Care Wound Care Treatment Wound Management Wound Treatment 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 (Child, Adult)
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 47 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Danielle Zerr, MD MPH	Children's Oncology Group

More Information


Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT01817075 History of Changes
Other Study ID Numbers:	ACCL1034 NCI-2013-00595 ACCL1034 COG-ACCL1034 ACCL1034 UG1CA189955 U10CA095861
Study First Received:	March 20, 2013
Last Updated:	February 22, 2016
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 23, 2016