Taurolidine lock reduces recurrent catheter-related bloodstream infections in patients with chronic intestinal failure: A randomized, placebo-controlled trial in a real-world clinical setting.

BACKGROUND & AIMS

Recurrent catheter-related bloodstream infections (CRBSIs) are a frequent, severe, and costly complication of home parenteral support (HPS) in patients with chronic intestinal failure (CIF). While taurolidine-containing catheter locks have shown potential in preventing CRBSIs, real-world data on their effectiveness in reducing recurrent infections remain limited. This study aimed to assess the efficacy and safety of a 1.35% taurolidine-containing catheter lock solution compared to standard-of-care 0.9% saline for the secondary prevention of recurrent CRBSIs in adult CIF patients.

METHODS

In this double-blind, placebo-controlled trial, adult CIF patients were age-matched, stratified by prior CRBSI incidence rates, and randomly assigned to use either a 1.35% taurolidine or a 0.9% saline lock for two years. The primary outcome was the difference in CRBSI occurrence between the two treatment groups, analyzed using the Andersen-Gill model with exact p-values obtained through a permutation test.

RESULTS

A total of 61 CIF patients were randomized, with 31 assigned to the 1.35% taurolidine lock (17,809 treatment days), and 30 to the 0.9% saline lock (18,692 treatment days). Six CRBSIs occurred in the taurolidine group compared to 27 in the saline group, corresponding to incidence rates of 0.35 and 1.46 per 1000 central venous catheter (CVC) days, respectively. Taurolidine use significantly reduced the rate of recurrent CRBSIs by 77% compared to saline (HR 0.23, 95% CI; 0.09-0.62, p-exact = 0.009). Furthermore, taurolidine significantly lowered the rate of CVC removals due to CRBSIs by 91% compared to saline (HR 0.09, 95% CI; 0.02-0.43, p-exact = 0.002). The Number Needed to Treat (NNT) was 892 treatment days (97.5% robust CI; 124-1660, p = 0.022).

CONCLUSIONS

This study demonstrates that the use of 1.35% taurolidine significantly reduces the rate of recurrent CRBSIs and CVC removals due to CRBSIs compared to 0.9% saline in adult patients with CIF reliant on HPS.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov, identifier: NCT06660641. https://clinicaltrials.gov/study/NCT06660641?term=NCT06660641&rank=1.

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