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

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.

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