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Summary

for people ages 2 months to 21 years (full criteria)
at Oakland, California and other locations
study started
estimated completion:

Description

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.

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)

Details

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.

Keywords

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 Chlorhexidine Chlorhexidine gluconate

Eligibility

You can join if…

Open to people ages 2 months to 21 years

  • 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

You CAN'T join if...

  • 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

Locations

  • Children's Hospital Los Angeles
    Los Angeles, California, 90027, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, 91010, United States
  • Miller Children's and Women's Hospital Long Beach
    Long Beach, California, 90806, United States
  • Children's Hospital of Orange County
    Orange, California, 92868, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Oncology Group
ID
NCT01817075
Phase
Phase 3
Study Type
Interventional
Last Updated
April 1, 2017