Acute Myeloid Leukemia Clinical Trial
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
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.
Full 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 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
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There are 58 Locations for this study
Duarte California, 91010, United States
Long Beach California, 90806, United States
Los Angeles California, 90027, United States
Madera California, 93636, United States
Oakland California, 94609, United States
Orange California, 92868, United States
San Francisco California, 94143, United States
San Francisco California, 94158, United States
Torrance California, 90502, United States
Hartford Connecticut, 06106, United States
New Haven Connecticut, 06520, United States
Wilmington Delaware, 19803, United States
Washington District of Columbia, 20010, United States
Jacksonville Florida, 32207, United States
Orlando Florida, 32827, United States
Pensacola Florida, 32504, United States
Saint Petersburg Florida, 33701, United States
Tampa Florida, 33606, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60612, United States
New Orleans Louisiana, 70118, United States
New Orleans Louisiana, 70121, United States
Bangor Maine, 04401, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Kansas City Missouri, 64108, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10467, United States
New Hyde Park New York, 11040, United States
New York New York, 10032, United States
Valhalla New York, 10595, United States
Winston-Salem North Carolina, 27157, United States
Toledo Ohio, 43606, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Sioux Falls South Dakota, 57117, United States
Chattanooga Tennessee, 37403, United States
Memphis Tennessee, 38105, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78723, United States
Corpus Christi Texas, 78411, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78207, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98105, United States
Spokane Washington, 99204, United States
Tacoma Washington, 98431, United States
Green Bay Wisconsin, 54301, United States
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3H 1, Canada
San Juan , 00912, Puerto Rico
San Juan , 00926, Puerto Rico
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