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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)

ConditionCentral Line Associated Blood Stream Infections (CLABSI)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorCorMedix Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • (taurolidine and heparin) catheter lock solution

    Drug

    for central venous catheter installation use

  • Heparin

    Drug

    Heparin

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: DefenCath®Experimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Secondary outcomes

1

Incidence of AEs, SAEs, treatment-emergent adverse events (TEAEs)

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

Time frame
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)
2

Incidence of changes in laboratory evaluations, vital signs, or physical exam findings

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

Time frame
Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CorMedix Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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