Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant: a Randomized, Multicenter, Double-blind , Placebo-controlled Study Evaluating Twice Daily Oral Xylitol
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 256
- 试验地点
- 3
- 主要终点
- Bacteremia from an oral organism
研究概览
简要总结
Bloodstream infections (BSI) caused by bacteria translocating across injured oral mucosa are a significant cause of morbidity and mortality in patients undergoing stem cell transplantation (SCT). Unfortunately, there are currently no known strategies to prevent these BSI in this vulnerable population. The investigators will conduct a randomized, double-blind, placebo-controlled trial at three institutions to evaluate the effectiveness of twice daily intraoral xylitol-wipe application on reducing BSI in pediatric SCT patients.
详细描述
Patients will be randomized to receive either twice-daily intraoral grape-flavored xylitol-wipe (intervention arm) or grape-flavored saline wipe (control arm) application in addition to the current standard of care (SOC). The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, mucositis (redness and ulcers in the mouth), or gingivitis in patients who undergo allogeneic stem cell transplant (SCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants, parents/guardians, nursing staff (interventionists), oral evaluators, and investigators will be blinded to the intervention, administered in the form of twice-daily grape-flavored xylitol wipes or grape-flavored saline wipes (controls). Preformed packets will be prepared by CCHMC Investigational Pharmacy staff, which will consist of either saline wipes with natural grape flavoring or xylitol. The color, taste, and smell of the wipes will be identical. The statistician will be unblinded to treatment assignment for the analysis.
入排标准
- 年龄范围
- 4 Months 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent and assent (when applicable) form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Admitted and planning to undergo an allogeneic stem cell transplant (SCT) at Cincinnati Children's Hospital Medical Center (CCHMC), Boston Children's Hospital, or Children's Hospital of Colorado (Denver).
- •Male or female, 4 months to 25 years of age at the time of SCT (Day 0)
- •Have a minimum of one tooth
- •Agree to avoid chewing gum and toothpaste that contains xylitol during the intervention period
排除标准
- •Prior radiation treatment for cancer of the oral cavity, head, or neck in the past 6 months per the study participant's medical record
- •Cranial boost in patients receiving total body irradiation
- •Known history of allergy to xylitol
- •Known history of allergy to grapes or grape flavoring
- •Undergoing a conditioning-free allogeneic stem cell transplant (patient does not receive any chemotherapy or radiation prior to stem cell infusion)
研究组 & 干预措施
Xylitol
Xylitol, a naturally occurring sugar alcohol found in plums, strawberries, and various vegetables such as cauliflower, has been approved for use in food by the US FDA since 1963. Spiffies Xylitol Wipes will be used.
干预措施: Xylitol (Other)
Grape-flavored Wipes
Grape-flavored wipes will be used with 2 drops of PCCA colorless grape flavoring. The grape-flavored wipes each contain a solution of 0.9% Sodium Chloride, purified water, and Benzalkonium chloride. PCCA artificial colorless grape flavoring will be used. The PCCA grape flavoring contains propylene glycol, ethyl alcohol, and artificial flavoring.
干预措施: Placebo (Other)
结局指标
主要结局
Bacteremia from an oral organism
时间窗: 33 days
Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo
次要结局
- Bacteremia from other non-oral flora organisms(33 days)
- Dental plaque(33 days)
- Gingivitis(33 days)
- Objective mucositis(33 days)
- Patient-reported mucositis(33 days)
- Oral microbiome diversity(33 days)