Drug updated on 12/11/2024
| Dosage Form | Catheter lock solution (central venous catheter; taurolidine 40.5 mg/3 mL [13.5 mg/mL], and heparin 3,000 USP Units/3 mL [1,000 USP Units/mL]; taurolidine 67.5 mg/5 mL [13.5 mg/mL], and heparin 5,000 USP Units/5 mL [1,000 USP Units/mL]) |
| Drug Class | Thiadiazinane antimicrobials and anti-coagulants |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).
Latest News
Summary
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- LOCK IT-100 Trial: In the LOCK IT-100 trial, taurolidine/heparin significantly reduced the risk of catheter-related bloodstream infections (CRBSIs) compared to heparin alone, with CRBSIs occurring in 2% of patients in the taurolidine/heparin group versus 8% in the heparin group. The hazard ratio (HR) was 0.29 (95% Confidence Interval [CI], 0.14 to 0.62), corresponding to a 71% reduction in CRBSI risk (P < 0.001).
- High-Risk Neutropenic Patients Trial: In a trial involving high-risk neutropenic hematologic patients, taurolidine-citrate-heparin showed a trend toward reduced bacterial colonization compared to placebo (4.1% vs. 10.1%; relative risk (RR) = 0.41, 95% CI, 0.11 to 1.52), but this difference was not statistically significant. Additionally, no significant differences were observed in secondary outcomes, including CRBSI incidence or catheter removal.
- In the LOCK IT-100 trial, the safety profile of taurolidine/heparin was comparable to heparin, with most treatment-emergent adverse events being mild or moderate. The Data and Safety Monitoring Board recommended early termination of the trial for efficacy, with no safety concerns.
- In the trial involving hematologic patients, no adverse events related to the administration of the taurolidine-citrate-heparin lock solution were reported, indicating a favorable safety profile compared to placebo.
- The LOCK IT-100 trial involved adults with kidney failure undergoing maintenance hemodialysis via Central Venous Catheters (CVCs) and showed that taurolidine/heparin significantly reduced the risk of CRBSIs compared to heparin alone. The trial involving hematologic patients included high-risk neutropenic patients with nontunneled CVCs, and while taurolidine-citrate-heparin showed a trend toward less bacterial colonization, it was not statistically significant. No significant differences in effectiveness were observed among subgroups within these populations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| DefenCath (taurolidine and heparin) Prescribing Information. | 2023 | CorMedix, Inc., Berkeley Heights, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Taurolidine/Heparin Lock Solution and Catheter-Related Bloodstream Infection in Hemodialysis: A Randomized, Double-Blind, Active-Control, Phase 3 Study | 806Subjects F: 42% M: 58% | 2023 | Clinical Journal of the American Society of Nephrology |
| A Randomized, Double-Blind, Placebo-Controlled Trial (TAURCAT Study) of Citrate Lock Solution for Prevention of Endoluminal Central Venous Catheter Infection in Neutropenic Hematological Patients | 150Subjects F: 48% M: 52% | 2020 | Antimicrob Agents and Chemotherapy |
Sex Distribution:
F:42%
M:58%
806Subjects
Year:
2023
Source:Clinical Journal of the American Society of Nephrology
Sex Distribution:
F:48%
M:52%
150Subjects
Year:
2020
Source:Antimicrob Agents and Chemotherapy