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
Condition: Bacterial Infection; Benign Neoplasm; Malignant Neoplasm; Methicillin-Resistant Staphylococcus Aureus Infection; Myeloid Neoplasm; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Sepsis; Staphylococcal Infections; Leukemia; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence
Intervention: Chlorhexidine Gluconate Skin Cleanser; Laboratory Biomarker Analysis; Mild Soap Skin Cleanser; Questionnaire Administration
Intervention description: Given CHG cleansing; Correlative studies; Given control cleansing; Ancillary studies
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 177.0
Sex: All
Minimum age: 2 Months
Maximum age: 21 Years
Healthy volunteers: No

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.
    

Eligibility 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