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Azeptic Trial Update
Issue 6, April 17, 2007

Newest Member of Ash Team at Averion As the Ash study continues to grow (from 10 to 20 sites!), so does the Averion in-house team. Sharon Smith will be the Lead CRA for the Ash study. We hope to get Sharon out on some co-monitoring visits in the very near future so you can meet her. The study contact sheet will be updated with Sharon’s contact information and sent to all of you. In the meantime, if you need to get in touch, she can be reached at 508-597-6102 or by E-mail at ssmith@averionintl.com

Tip of the Month
Worksheet Completion

Don’t forget to re-screen your screen failures! If a screened patient is a screen failure due to antibiotic use or a positive blood culture, be sure to re-screen the patient once they become eligible again.

CRF Pages

At least one copy of each CRF page needs to be completed for each patient. If there is no data recorded on a CRF page, please complete the header information and line through, initial and date the page.

Upcoming Events

There will be a Principal Investigator/Study Coordinator teleconference scheduled for Thursday April 19th at 1:00 PM EDT OR Friday April 27th at 1:00 PM EDT. An agenda and call in number will be provided prior to each call. Please email Sharon Smith at ssmith@averionintl.com, if you haven’t RSVP’d yet.

New Site Updates

Enrollment Progress As of 4/17/07
Please remember to send in your enrollment log each Friday
Dr. Hariachar, Hudson, FL (101)
32
Dr. Stephanz, (102)
1
Dr. Fadem, Houston, TX (103)
5
Dr. Rogers, Ocala, FL (104)
16
Dr. Block, Denver, CO (105)
4
Dr. Kopelman, Bakersfield, CA (106)
22
Dr. Al-Makki, Lafayette, IN (107)
8
Dr. Henriquez, Bronx, NY (108)
2
Dr. Khwaja, Newport Beach, CA (109)
39
Dr. Posner, Baltimore, MD (110)
3
Dr. Roer, Waterbury, CT (111)
23
Dr. Kapatkin, Brandon, FL (112)
5
Dr. Halligan, Erie, PA (113)
10
Dr. Abbott, Orlando, FL (114)
9
Dr. Cheriyan, Fairfax, VA (115)
0
Dr. Koeper, Appleton, WI (116)
5
Dr. Herman, Buffalo, NY (117)
6
Dr. Matalon, New York, NY (118)
0
Dr. Williamson (119)
0
Dr. Brown (120)
0
Total Randomized
186

Fun Stuff!

marathon graphic

This year is the 111th Boston Marathon. In terms of on-site media coverage, the Boston Marathon ranks behind only the Super Bowl as the largest single day sporting event in the world.


Helpful Tips from DaVita Labs

When reviewing monthly labs, if you are using the URR equivalent to the Kt/V less than 1.1, the minimum URR should be 68.

Remember!

If a patient is a screen failure, please be sure to record the reason for screen failure on the enrollment log. If you are re-screening a patient, please be sure to use a new screening number on the enrollment log. If the original screening number is required for the lab, be sure to use the new screening number when logging the information on the Averion enrollment log.

We like to keep in touch online. Please send us your current E-mail address for all study coordinators and Principal Investigators so that we are able to communicate effectively via E-mail.

Azeptic Trial


Don’t forget to fax your form back to Averion stating your intention to participate (or if you wish to decline participation) in the program. If you need another form, please contact Rita or Allie at Averion.

If you have any questions, please contact Rita (508-597-5773) or Allie (508-597-6223) at Averion.

 

Don't forget about the available AZEPTIC Trial patient & dialysis staff resources: Patient enrollment kits, pens, t-shirts, sponsor educational inservices, etc. Please contact Dan Olson at dolson@ashaccess.com if you have questions. for additional patient & dialysis staff resources.

 

From the Sponsor

April 2007

Over the course of the past few months, we have shared a great deal of information about the incidence of catheter related bloodstream infections and their significant impact on the lives of hemodialysis patients. Medical advances to reduce or eliminate these infections are in great demand, not only for patients in hemodialysis, but patients in acute and chronic hospital care.

We at Ash Access Technology are committed to meeting this unmet need. Our company was founded on the research and clinical successes of Dr. Stephen Ash. Dr. Ash’s relentless problem-solving pursuit, joined with the business acumen of our President and CEO, Bob Truitt, provide the cornerstones of our company.

We have assembled a team of employees, who effectively put our plans in motion. Many of you have met Carmine, Dan, Al and Roland. Dr. Janusz Steczko and Lloyd Brewer provide R&D under Dr. Ash’s direction and Ken Brown, an accomplished medical device engineer, manages our hemodialysis and peritoneal catheter projects. We are also grateful to have a solid and engaged Board of Directors who bring many years of experience and practical wisdom.

The folks that comprise our company are driven by our shared passion to solve the catheter infection challenge. And as much as we enjoy our individual work in pursuing this goal, we also enjoy getting to do this work together. Our team is indeed a team.

Yet, our founders, our employees, and our board do not complete the picture of our company. At this particular point in time, though, the most significant people on our team have not yet been mentioned. For at this time, a time where our company’s flagship product is in its final clinical study prior to FDA approval, the people carrying out that study are absolutely essential to our success. You are the most significant people we’ve got. You will be the ones to say “I was part of significantly improving the way the world cares for catheter patients.” We hope you are as excited as we are in seeing yourselves in such a unique role for such a unique product and such a unique opportunity.

Your commitment and hard work are paying off. The Enrollment Surge has begun, and with your continued dedication, we will complete this study, and we will all be proud. We look forward to supporting your work and seeing your successes in the weeks ahead. Thank you!

 

Device Accountability Logs

Please be sure you are keeping the Device Accountability Logs current and up to date at each of your dialysis units. It is important to accurately log the use of all Zuragen at each dialysis unit. The Dialysis Binders provided to each site/satellite site includes a Device Accountability Log—you should be using the Device Transfer Forms to document moving the device from one unit to another. If you have any questions with this process, please contact the in-house team at Averion or your monitor.


Medical Monitor Phone Number: (765) 413-7676
All questions regarding Inclusion/Exclusion criteria compliance, potential adverse device effects, patient safety, and other medical issues related to the study should be referred to the Medical Monitor.

 

Since you are reading this page, you are already aware of the Clinical Trial page on this website. Make sure you notice that the Clinical Trial page contains all issues of the study newsletter, a PDF of the trial poster and local newsletter example, site contact information, Q&A log, and CRF re-order form. Please contact Averion or Ash Access if you think of any useful additions to the website, or have any feedback!