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

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; 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

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)
Study Start Date :	November 2013
Estimated Primary Completion Date :	September 30, 2018
Estimated Study Completion Date :	September 30, 2018

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.	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

Outcome Measures

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Primary Outcome Measures :

1. Number of CLABSI events during the at-risk days [ Time Frame: Up to 90 days ]
   Estimated and compared between the 2 arms by a Poisson regression model adjusting for the randomization stratification factor on treatment/diagnosis.

Secondary Outcome Measures :

1. Acquisition of MDRO [ Time Frame: Up to 90 days ]
   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.
2. Susceptibility to CHG as measured by minimum inhibitory concentrations and minimum bactericidal concentrations [ Time Frame: Up to 90 days ]
   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.
3. Number of bacteremia episodes during the at-risk days [ Time Frame: Up to 90 days ]
   Poisson regression model used for detecting the reduction in the rate of bacteremia at 2-sided alpha level of 0.05.

Other Outcome Measures:

1. Patient satisfaction survey [ Time Frame: Up to 90 days ]
   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.

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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  Show 44 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT01817075 History of Changes
Other Study ID Numbers:	ACCL1034; NCI-2013-00595 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); ACCL1034 ( Other Identifier: Children's Oncology Group ); COG-ACCL1034 ( Other Identifier: DCP ); ACCL1034 ( Other Identifier: CTEP ); UG1CA189955 ( U.S. NIH Grant/Contract ); U10CA095861 ( U.S. NIH Grant/Contract )
First Posted:	March 22, 2013
Last Update Posted:	February 6, 2018
Last Verified:	February 2018

Additional relevant MeSH terms:

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