To: Cacaito who wrote (12367 ) 12/2/1999 11:25:00 AM From: franksja Respond to
Thanks for your comments. It seems to me that a critical element of information is missing in PII Trauma--TIMING of when the other antibiotics were started. There was a period of time between the time the trauma occurred and the first day of the study. It was during this initial time that the blood loss with translocation occurred. The entry into the study requires informed consent, but first the patient (typically) is undergoing surgery, recovery, and Intensive Care in the ICU. It's just a guess on my part, but I estimate that 1 to 3 days between the time of the trauma and entry into the study. It is clear that the other antibiotics were not automatically given to the patients, probably not given until symptoms of infection. Some were never given antibiotics (other than Neuprex). It could be that Neuprex being given before the other antibiotics would explain why the number of people receiving antibiotics was less in the Neuprex group. Hopefully, this information (timing) is available to XOMA, but the report raises questions in my mind. Sample size and percentage of confidence are factors determining statistical significance in addition to the results. Also, there were four other antibiotics used--was there a difference in results for the four different antibiotics. In my opinion, the results SUGGEST that Neuprex was helpful. My guess is that XOMA was able to zero in on some of this information and designed PIII to capture clear benefit of Neuprex. On the other hand, if I were running a trauma center and read this report in the Journal of Trauma, I would consider giving antibiotics much sooner after the trauma event. If this did occur, then the test results could be dramatically changed--perhaps explaining PIII. I think the jury is still out. Thanks again for your response. Jim Franks
