Infections

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Rare Diseases

Bacterial Infections

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Leukemia, Myeloid

Leukemia, Myeloid, Acute

Communicable Diseases

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Sepsis

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Staphylococcal Infections

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Disease Attributes

Neoplasms by Histologic Type

Hematologic Diseases

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Bacterial Infections and Mycoses

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Anti-Infective Agents

All Drugs and Chemicals

Dermatologic Agents

Chlorhexidine

Chlorhexidine gluconate

Anti-Infective Agents, Local

Disinfectants

Patients receive CHG cleansing with topical skin wipes QD for 90 days.

Patients receive control cleansing with topical skin wipes QD for 90 days.

Chlorhexidine Gluconate Skin Cleanser

Laboratory Biomarker Analysis

Mild Soap Skin Cleanser

Questionnaire Administration

Danielle M Zerr

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.

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.

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

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)

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.

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.

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.

A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place.

National Cancer Institute (NCI)

Children's Oncology Group

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Patients receive CHG cleansing with topical skin wipes QD for 90 days.

Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing

Laboratory Biomarker Analysis: Correlative studies

Questionnaire Administration: Ancillary studies

Arm I (CHG Cleansing Wipe)

Patients receive control cleansing with topical skin wipes QD for 90 days.

Laboratory Biomarker Analysis: Correlative studies

Mild Soap Skin Cleanser: Given control cleansing

Questionnaire Administration: Ancillary studies

Arm II (Control)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Canada

Region of Enrollment

Results Reporting Coordinator

3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses.

Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days

Percentage of Patients With Multi-drug Resistant Organisms (MDRO)

135 participants contributed a baseline and at least one follow-up swab and were included in this analysis

Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG)

3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analysis.

Rate of Bacteremia Per 1000 At-risk Days

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT01817075	Bacterial Infec... Benign Neoplasm Malignant Neopl... Methicillin-Res... Myeloid Neoplas... Recurrent Child... Recurrent Child...	Chlorhexidine G... Laboratory Biom... Mild Soap Skin ... Questionnaire A...	2 Months - 21 Years	Children's Oncology Group
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	NCT01817075	Bacterial Infec... Benign Neoplasm Malignant Neopl... Methicillin-Res... Myeloid Neoplas... Recurrent Child... Recurrent Child...	Chlorhexidine G... Laboratory Biom... Mild Soap Skin ... Questionnaire A...	2 Months - 21 Years	Children's Oncology Group

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