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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 118
- 主要终点
- Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days
时间窗: Up to 90 days post enrollment date
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.
次要结局
- Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG)(Up to 90 days post enrollment date)
- Percentage of Patients With Multi-drug Resistant Organisms (MDRO)(Up to 90 days post enrollment date)
- Rate of Bacteremia Per 1000 At-risk Days(Up to 90 days post enrollment date)