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Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)

2026년 9월 22일 업데이트: CorMedix Therapeutics

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)

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

200

단계

  • 3단계

확장된 액세스

더 이상 사용할 수 없음 임상시험 외. 확장 액세스 기록을 참조하세요.

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Liz Hurlburt, Chief Clinical Strategy & Operations Officer
  • 전화번호: 908-517-9500
  • 이메일: lhurlburt@cormedix.com

연구 장소

  • 미국
    • California
      • Los Angeles, California, 미국, 90024
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20010
    • Florida
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • 모병
        • Emory University Hospital - GCRC
        • 연락하다:
        • 연락하다:
    • Illinois
      • Chicago, Illinois, 미국, 60637
      • Maywood, Illinois, 미국, 60153
        • 모병
        • Loyola University Medical Center
        • 연락하다:
        • 연락하다:
    • Iowa
      • Iowa City, Iowa, 미국, 52242
        • 모병
        • University of Iowa Health Care
        • 연락하다:
        • 연락하다:
    • Maryland
      • Baltimore, Maryland, 미국, 21205
        • 모병
        • Johns Hopkins Clinical Research Unit
        • 연락하다:
        • 연락하다:
    • Minnesota
    • Nebraska
      • Omaha, Nebraska, 미국, 68198-3285
        • 모병
        • University of Nebraska Medical Center
        • 연락하다:
          • David F Mercer, MD, PhD, FRCS(C)
          • 전화번호: 402-559-6955
          • 이메일: dmercer@unmc.edu
        • 연락하다:
    • New York
      • New York, New York, 미국, 10032
        • 모병
        • Columbia University Irving Medical Center
        • 연락하다:
        • 연락하다:
      • New York, New York, 미국, 10029
      • New York, New York, 미국, 10016
        • 아직 모집하지 않음
        • NYU Grossman School of Medicine
        • 연락하다:
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • 빼는
        • Duke University Hospital
    • Ohio
      • Cleveland, Ohio, 미국, 44195
        • 모병
        • Cleveland Clinic Foundation
        • 연락하다:
        • 연락하다:
          • Jessica Sosio, DO
          • 전화번호: 216-442-2416
          • 이메일: sosioj@ccf.org
    • Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • 모병
        • Rhode Island Hospital
        • 연락하다:
        • 연락하다:
    • Tennessee
      • Nashville, Tennessee, 미국, 37212-1150
        • 모병
        • Vanderbilt Center for Human Nutrition
        • 연락하다:
        • 연락하다:
    • Texas
      • Sugarland, Texas, 미국, 77478
  • 터키 (Türkiye)
    • Ankara
      • Altındağ, Ankara, 터키 (Türkiye), 06230
        • 모병
        • Hacettepe University Hospitals
        • 연락하다:
        • 연락하다:
      • Yenimahalle, Ankara, 터키 (Türkiye), 06560
        • 모병
        • Hacettepe University Hospitals
        • 연락하다:
        • 연락하다:
      • Çankaya, Ankara, 터키 (Türkiye), 06800
        • 모병
        • Ankara Bilkent City Hospital
        • 연락하다:
        • 연락하다:
      • Çankaya, Ankara, 터키 (Türkiye), 06230
        • 모병
        • Ankara University Ibni Sina Research and Application Hospital
        • 연락하다:
        • 연락하다:
    • Istanbul
      • Istanbul, Istanbul, 터키 (Türkiye), 34093

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

  1. Participants who are resident within study site's country.

  2. Participants who are male or female, aged ≥12 years at the time of consent.

  3. 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.

  4. 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.

  5. Participants who require long-term (>3 Months) TPN based on the investigator assessments.

  6. Participants who require TPN for at least 3 days per week, of which 2 days have to be parenteral nutrition (PN).

  7. 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.

  8. Participants who are clinically stable, in the opinion of the investigator, for at least 4 weeks prior to enrollment.

  9. 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:

  10. 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).

  11. 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.

  12. Participants who comply with all study procedures and follow-up evaluations.

Exclusion Criteria:

  1. Any participant unable or not willing to sign inform consent or, in the case of adolescents, not willing to provide assent.
  2. 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.
  3. Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.
  4. Any participant with a secondary CVC in addition to the primary TPN line.
  5. 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.
  6. Any participant with unstable arrhythmia, defined as presence of hemodynamic instability within a month prior to the baseline assessment.
  7. Any participant using any type of antimicrobial-coated or heparin-coated catheter.
  8. Any participant with documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization.
  9. Any participant with a congenitally lethal condition or a life expectancy of less than 6 months.
  10. Any participant with documented history of an atrial thrombus or known hypercoagulable state.
  11. Any participant with an open, non-healing skin ulcer.
  12. Any participant who has received an allogeneic hematopoietic stem cell transplant within the last year.
  13. Any participant with neutropenia with an absolute neutrophil count <500 cells/μL
  14. 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.
  15. Any participant with known allergies or absolute contraindications to citrate, taurolidine, pork products, or heparin or a history of heparin-induced thrombocytopenia.
  16. Any participant taking other medication with known systemic drug interaction with citrate, taurolidine or heparin.
  17. 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.
  18. Any participant who is pregnant or lactating.
  19. Any participant receiving continuous TPN (infusion over 24 hours).
  20. 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.
  21. 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 제어
의약품: Heparin

Heparin
실험적: 디펜캐스®
의약품: (taurolidine and heparin) catheter lock solution

for central venous catheter installation use

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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.
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

2차 결과 측정

결과 측정
측정값 설명
기간
Incidence of AEs, SAEs, treatment-emergent adverse events (TEAEs)
기간: Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Compare the safety profile of DefenCath for use as a Catheter Lock Solution (CLS) in adult and adolescent participants receiving Total Parenteral Nutrition (TPN) through a Central Venous Catheter (CVC) to the control of heparin CLS
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
기간: Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Compare the safety profile of DefenCath for use as a CLS in adult and adolescent participants receiving TPN through a CVC to the control of heparin CLS
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

CorMedix Therapeutics

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 5월 14일

기본 완료 (추정된)

2028년 1월 1일

연구 완료 (추정된)

2028년 1월 1일

연구 등록 날짜

최초 제출

2025년 1월 15일

QC 기준을 충족하는 최초 제출

2025년 2월 6일

처음 게시됨 (실제)

2025년 2월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 22일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NUTRI-GUARD

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Sharibg if protocol and ICF, pending FDA approval of this indication

IPD 공유 기간

Pending FDA Approval

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다