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NUMP historyJust to clear up some possible historical confusion about NUMP for readers of this message board. Cormedix commissioned the NUMP study which was run at 20 sites in Germany from January 2014 until October 2016. Some "live" preliminary top line results were being released during 2015. The numbers most may remember were a reduction of 96.x% over a "straw man" real world CRSBI rate of 3,5 CRSBIs per 1000 catheter-days. There were only 5 CRSBIs in the first ~31460 catheter-days. This was a unblinded SINGLE-arm study where all patients had Neutrolin as their catheter-lock. The study continued to accrue catheter-days until October 2016. A final formal study paper was published in April 2018 detailing the official results after the study was complete and the database cleansed and locked. The final results had likely CRSBIs at 13 over 47,118 catheter-days, a rate of 0.2759 which equates to a 92.1% reduction from a historical control rate of 3.5 per 1000 catheter days. The thrombosis rate was .1486 per 1000 catheter days. So, we were getting some live updates in 2015, then the study went into a quiet mode while the researches wrote the formal study paper and published it 18 months later at the National Institutes of Health. Postmarketing Experience with Neutrolin (link to abstract) This is where the "memory" of 96% reduction comes from. The actual final data is the rate of infection of .2795 per 1000 catheter days- which was very good, indeed. (equivalent to a 92.1% reduction from 3.5) Occasionally, the thrombosis number of 0.14 has been used inadvertently, as well. Here is Rob Cos's post that was accurate and up to date at the time. |
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