NCT06822426招募中3 期
A Phase 3, Prospective, Multicenter, Double-Blind, Randomized, Controlled, Adaptive Study To Demonstrate The Safety And Efficacy Of DEFENCATH® In Reducing Central Line-Associated Bloodstream Infections (CLABSIs) In Adult And Adolescent Participants Receiving Total Parenteral Nutrition (TPN) Via Central Venous Catheter (CVC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 36
- 主要终点
- Comparison between treatment groups of proportion of participants who experience a Central Line-Associated Bloodstream Infections (CLABSI) within 12 months of the start of the study
研究概览
简要总结
This is a Phase 3, randomized, double-blind, controlled, adaptive, 2-arm, multicenter study to demonstrate the efficacy and safety of DefenCath in adult and adolescent participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.
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)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are resident within study site's country.
- •Participants who are male or female, aged ≥12 years at the time of consent.
- •Participants must sign and provide informed consent. For adolescent participants or participants that require a legal representative, written informed consent will be obtained from the study participant's legal guardian or legal representative and the assent from the participant when applicable. All legal guardians and representatives should be fully informed, and participants should be informed to the fullest extent possible about the study using language and terms they are able to understand.
- •Participants who have a tunneled/non-tunneled CVC or peripherally inserted central catheter (PICC) made of silicone or polyurethane, which has been in place for at least 7 days prior to enrollment.
- •Participants who require long-term (>3 Months) TPN based on the investigator assessments.
- •Participants who require TPN for at least 3 days per week, of which 2 days have to be parenteral nutrition (PN).
- •Participants who have a minimum of a 4-hour CLS dwelling time and are willing to lock all lumens at a minimum of every 7 days.
- •Participants who are clinically stable, in the opinion of the investigator, for at least 4 weeks prior to enrollment.
- •Participants who are able and willing to be trained or have a caregiver who is willing and able to be trained on the instillation, aspiration of DefenCath or heparin, and to maintain a daily diary.
- •Male or female participants:
- •Women of childbearing potential (WOCBP; see Section 4.5.1) must have a negative pregnancy test at screening (i.e., the participant is not pregnant); not be lactating; and use an acceptable method of contraception including but not limited to, abstinence, bilateral tubal ligation, vasectomized partner, a barrier method (diaphragm or condom), Depo-Provera, intrauterine device, or hormonal contraceptive (oral, implant, ring, patch) for the duration of the program until at least 30 days after the last DefenCath CLS instillation. (NOTE: The participant must have used the chosen method of birth control for at least 1 month/cycle prior to enrollment into the study).
- •Male participants who are sexually active with a female partner of childbearing potential must agree to use male condoms with spermicide, even if the male participant has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last DefenCath CLS instillation.
- •Participants who comply with all study procedures and follow-up evaluations.
排除标准
- •Any participant unable or not willing to sign inform consent or, in the case of adolescents, not willing to provide assent.
- •Any participant who is currently receiving systemic antibiotics. Topical antibiotics are permitted. Use of metronidazole or rifaximin for treating small intestinal bacterial overgrowth (SIBO) is also permitted.
- •Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.
- •Any participant with a secondary CVC in addition to the primary TPN line.
- •Any participant that has received thrombolytic treatment (e.g., tissue-type plasminogen activator [tPA]-Cathflo), not as a part of the institution's standard of care for patency management, in current catheter within 30 days of randomization.
- •Any participant with unstable arrhythmia, defined as presence of hemodynamic instability within a month prior to the baseline assessment.
- •Any participant using any type of antimicrobial-coated or heparin-coated catheter.
- •Any participant with documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization.
- •Any participant with a congenitally lethal condition or a life expectancy of less than 6 months.
- •Any participant with documented history of an atrial thrombus or known hypercoagulable state.
- •Any participant with an open, non-healing skin ulcer.
- •Any participant who has received an allogeneic hematopoietic stem cell transplant within the last year.
- •Any participant with neutropenia with an absolute neutrophil count <500 cells/μL
- •Any participant with current requirement for systemic chemotherapy and or immunosuppression and absolute neutrophil count <500 cells/μL that occured in the past 4 weeks.
- •Any participant with known allergies or absolute contraindications to citrate, taurolidine, pork products, or heparin or a history of heparin-induced thrombocytopenia.
- •Any participant taking other medication with known systemic drug interaction with citrate, taurolidine or heparin.
- •Any participant anticipating receiving an intestinal transplant within 90 days. Participants can be on a transplant list but a participant with a known or anticipated transplant date within 90 days of study entry should be excluded from study participation. A participant who may receive an intestinal transplant >90 days of study entry may remain on the study as long as they continue to receive TPN.
- •Any participant who is pregnant or lactating.
- •Any participant receiving continuous TPN (infusion over 24 hours).
- •Any participant with any medical conditions that render them unable to, or unlikely to complete the study or would interfere with optimal participation in the study or produce significant risk to participant.
- •Any participants who are participating in another interventional clinical study or planning/anticipating participating in another interventional clinical study, except for non-pharmacological research studies.
研究组 & 干预措施
DefenCath®
Experimental
干预措施: (taurolidine and heparin) catheter lock solution (Drug)
Control
Active Comparator
干预措施: Heparin (Drug)
结局指标
主要结局
Comparison between treatment groups of proportion of participants who experience a Central Line-Associated Bloodstream Infections (CLABSI) within 12 months of the start of the study
时间窗: Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)
The proportion of participants who remain infection-free in the treatment groups will be compared, censoring participants who do not experience a CLABSI, but fail to complete the 12-month follow-up period of the study.
次要结局
- Incidence of AEs, SAEs, treatment-emergent adverse events (TEAEs)(Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months))
- Incidence of changes in laboratory evaluations, vital signs, or physical exam findings(Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months))
研究者
研究点 (36)
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