A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 556
- 试验地点
- 40
- 主要终点
- Number of bloodstream infections (BSI) from oral flora
研究概览
简要总结
This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.
详细描述
PRIMARY OBJECTIVE:
I. To compare the incidence rate of bloodstream infections (BSI) (BSI per 1000 patient-days) from oral organisms over 2 cycles of chemotherapy in children with acute myeloid leukemia (AML) randomized to xylitol-containing oral wipes (xylitol dental wipes) versus control wipes.
SECONDARY OBJECTIVE:
I. To compare the rate of BSI (BSI per 1000 patient-days) from any organism in patients randomized to xylitol dental wipes versus control wipes.
EXPLORATORY OBJECTIVES:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The subject, investigators, and site-specific research and clinical staff who are involved with the conduct of the study will remain blinded to the treatment. The presence of a BSI event (either single organism or polymicrobial) will be determined by review of microbiology reports submitted to a central review committee whose members will be blinded to treatment allocation.
入排标准
- 年龄范围
- 1 Year 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be ≥ 1 year to ≤ 25 years old at enrollment.
- •Patient must have a diagnosis of AML according to the 2016 World Health Organization classification with or without extramedullary disease. Patients with either newly diagnosed or relapsed AML are eligible as long as they meet the planned treatment criteria.
- •Patient should be planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy. Each cycle must:
- •Contain IV cytarabine (liposomal formulations allowed), and
- •The duration of severe neutropenia should be expected to be ≥ 7 days. Hematopoietic stem cell transplantation (HSCT) conditioning cannot count as one of the two required planned cycles.
- •Note: Patients do not need to be co-enrolled on an upfront AML treatment protocol study, but co-enrollment is permitted.
- •Minimum of one visible or erupted tooth.
- •Agree to avoid xylitol containing gum or toothpaste during intervention period.
- •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 Down syndrome-associated AML.
- •Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record.
- •Patients with known history of allergy to xylitol.
- •Patients with known history of allergy to grapes or grape flavoring.
- •Patients who are actively being treated for an oral organism related blood stream infection.
- •Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.
研究组 & 干预措施
Arm I (xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Best Practice (Other)
Arm I (xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm I (xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Electronic Health Record Review (Other)
Arm I (xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Xylitol-containing Oral Wipe (Other)
Arm II (non-xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a non-xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Best Practice (Other)
Arm II (non-xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a non-xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm II (non-xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a non-xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Electronic Health Record Review (Other)
Arm I (xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Cytarabine (Drug)
Arm II (non-xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a non-xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Cytarabine (Drug)
Arm II (non-xylitol dental wipe)
Patients receive standard chemotherapy containing cytarabine IV on study and receive a non-xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC >= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
干预措施: Placebo Administration (Drug)
结局指标
主要结局
Number of bloodstream infections (BSI) from oral flora
时间窗: Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study
Will report the estimated oral organism BSI incidence rates by arm as number of events per 1000 patient-days. We will also report the incidence rate ratio under a Poisson regression model contrasting incidence rates of oral organism BSI for the treatment relative to control arm and the corresponding 95% confidence interval.
Number of bloodstream infections (BSI) from oral flora
时间窗: Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study
Will report the estimated oral organism BSI incidence rates by arm as number of events per 1000 patient-days. Will also report the incidence rate ratio under a Poisson regression model contrasting incidence rates of oral organism BSI for the treatment relative to control arm and the corresponding 95% confidence interval.
次要结局
- Number of BSI from any organism(Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study)