Randomized Double Blind Controlled Trial for the Treatment of Nucleic Acid Amplification Test (NAAT)+/Toxin Enzyme Immunoassay (EIA)- Clostridium Difficile in the Hematology Oncology Population
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Changes in Clostridium difficile bacterial loads in the stool
研究概览
简要总结
This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo. The study is designed to include 30 patients (15 per arm).
Outcomes will include C. difficile load using qPCR, VRE loads, structural and functional microbiome changes and frequency of bowel movements. All endpoints will be measured at several time points including days 0, 14, 21 and 90.
详细描述
The adverse health consequences resulting from antibiotic overtreatment of NAAT(+), toxin(-) patients may be particularly important in transplant recipients. The usual treatment prescribed for CDI at the Froedtert Memorial Lutheran Hospital is oral vancomycin. While this drug has excellent activity against C. difficile and commonly suppresses its growth to non-detection, it does not eradicate carriage and its use results in marked and prolonged disruption of the lower intestinal microbiota. Meanwhile, the degree of lower intestinal microbiota disruption at the time of HSCT engraftment has been demonstrated to be an independent predictor (controlling for other markers of underlying disease) of overall and transplant-related 3-year mortality.14 In addition, recent findings suggest that bone marrow suppressive effects of antibiotics, in this case potentially unnecessary oral vancomycin (which is not appreciably absorbed), may be solely mediated via microbiota disruption. All these data supports the notion that antibiotic treatment of NAAT(+), toxin(-) C. difficile patients might have significant negative repercussions without a clear clinical benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The allocation status of patients within this study will be held in sealed envelopes by the unblinded research pharmacist on the team. Neither the main care provider, study physicians, or the patient will know of their group, until either the end of the study (after data analysis). We will also have a blinded pharmacist.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the hematology oncology inpatient units at Froedtert Memorial Lutheran Hospital
- •New onset of diarrhea during hospitalization
- •C. difficile clinical testing showing NAAT positive EIA negative results
排除标准
- •Being unable to consent for self
- •Inability to take enteral medications
- •Unwillingness to enroll in study
- •Patient has a documented allergy to vancomycin
- •Patient has a documented life expectancy shorter than treatment course (14 days)
- •Patient is unwilling or unable to provide stool samples in the outpatient setting after discharge
- •Diagnosis of C. difficile colitis [NAAT (+) and toxin EIA (+) within 3 months of enrollment).
- •New onset of abdominal distention within 24 hours prior to the onset of diarrhea during index admission
- •Presence of toxic megacolon
- •Presence of clinical sepsis. Sepsis will be defined as a Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions
- •Pregnancy or lactating
研究组 & 干预措施
Placebo group
This group will be given placebo oral capsules every 6 hours for 14 days.
干预措施: Placebo Oral Capsule (Drug)
Vancomycin treated group
This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.
干预措施: Vancomycin Oral Capsule (Drug)
结局指标
主要结局
Changes in Clostridium difficile bacterial loads in the stool
时间窗: Pre-treatment, 1, 7, 14, 21, 28, and 90 days past the beginning of treatment
Changes in Clostridium difficile bacterial counts from stool as determined by quantitative polymerase chain reaction (PCR)
Changes in Clostridium Difficile Bacterial Loads in the Stool
时间窗: First sample versus last stool sample collected, up to 90 days
Changes in Clostridium difficile bacterial counts from stool as determined by quantitative polymerase chain reaction (PCR). Values obtained from initial sample (pre-treatment) were compared with values from the last sample obtained for each patient.
次要结局
未报告次要终点
研究者
Silvia Munoz-Price
Professor
Medical College of Wisconsin