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Azeptic Trial Update
Issue 5, March 12, 2007

New Site Updates

Enrollment Progress As of 3/12/07
Dr. Hariachar, Hudson, FL (101)
30
Dr. Fadem, Houston, TX (103)
5
Dr. Rogers, Ocala, FL (104)
15
Dr. Block, Denver, CO (105)
4
Dr. Kopelman, Bakersfield, CA (106)
20
Dr. Al-Makki, Lafayette, IN (107)
5
Dr. Henriquez, Bronx, NY (108)
2
Dr. Khwaja, Newport Beach, CA (109)
37
Dr. Posner, Baltimore, MD (110)
1
Dr. Roer, Waterbury, CT (111)
22
Dr. Kapatkin, Brandon, FL (112)
1
Dr. Halligan, Erie, PA (113)
1
Dr. Abbott, Orlando, FL (114)
7
Dr. Cheriyan, Fairfax, VA (115)
0
Dr. Koeper, Appleton, WI (116)
0
Dr. Herman, Buffalo, NY (117)
0
Dr. Matalon, New York, NY (118)
0
Dr. Williamson (119)
0
Dr. Brown (120)
0
Total Randomized
151

Fun Stuff!

Saint Patrick was the patron saint and national apostle of Ireland who is credited with bringing Christianity to Ireland and is best known for driving all of the snakes out of Ireland.

Tip of the Month
All patients presenting with signs/symptoms of an infection should have blood cultures drawn (assess exit site—if suspicious, exit site culture should be performed). A limited history and physical should be performed to rule out alternate sources of infection. Record culture results in the CRF. IF fever was greater than 38ºC, and cultures results were concordant, complete the CRBSI worksheet and fax to the Blinded Evaluator.


FEATURE

AZEPTIC Trial Study Coordinator Meeting: Right Time, Right Place, Right People
It is often said that “timing” is everything. That statement couldn't have been more true for the timing of the AZEPTIC Trial Study Coordinator Meeting which was held in Orlando, Florida on February 23 & 24. Not only was it a great time of year to spend in sunny Florida but with the addition of 10 new study sites the meeting was an excellent opportunity for all team members to network, build relationships and share “best practices”. We are very fortunate that 31 study coordinators (representing 18 of the 19 active study sites) took the time to spend their weekend with us. More importantly, it was a great forum to discuss the pioneering research we are all participating in to address the significant unmet medical need patients are experiencing on a far too frequent basis: vascular access complications of catheter-related bloodstream infection and poor patency. In addition, we were able to review key aspects of the study protocol and CRFs as well as candidly share processes or practices that have been implemented at your site.

A big THANK YOU to Heather Pena (Hudson, FL) and Helen Brickel (Middlebury, CT) for sharing their insights with all of us. As you recall, Heather covered successful strategies for patient screening, consenting and enrollment while Helen addressed the keys to ensuring protocol execution and communication in each dialysis unit.

The feedback from the surveys you completed were overwhelmingly positive (see graphs below). We appreciate your comments and were glad you got as much out of the meeting as we did!


Question: How would you rate the effectiveness of the meeting content & format in meeting your needs as a SC for the AZEPTIC Trial?
Result: 90% of the SCs rated the meeting as Very Effective


Question: What is your confidence level that your team will meet your enrollment goal by June 15, 2007?
Result: Average SC Confidence Level in meeting patient enrollment “target” is 9.4

Confidence in Achieving Enrollment Targets

CRF TIPS

Surgical History Form—Page 9._

Record any relevant previous surgeries or procedures the subject may have experienced. Do not record the date the current CVCD or a previous CVCD was placed, as this will be captured on the Baseline CVCD history form.

*******

Please Note: If your site received any damaged Case Report Form binders they can be replaced by StatKing. Please contact Carolyn Buck or Marla Hoelle at (513) 858-2989.

Remember!
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.


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.

 

From the Sponsor

The arrival of March brings optimism to many about the coming of Spring. Our hope is that the weather isn't the only thing to heat up and put a “spring” in your step the next few months. With the recently completed AZEPTIC Trial Study Coordinator Meeting, we are very encouraged at the level of commit- ment, enthusiasm and focus the clinical trial team is giving to this pivotal study as well as the confidence you shared towards meeting your enrollment targets.

It is apparent from the comments, conversations and experiences discussed at the meeting that you are all well aware of the significant unmet medical need vascular access complications (catheter-related bloodstream infections - CRBSI and poor patency) have on your patients. The associated morbidity and mortality of these complications along with the health care costs required to treat them are astounding.

o CDC has identified catheter associated adverse events, including catheter-related bloodstream infections (CRBSIs) as 1 of its 7 major healthcare safety challenges

  • U.S. estimate for CRBSI: 200,000 – 400,000 episodes each year
  • Attributable mortality rate: 12% - 25% in published studies
  • Associated treatment costs: $2 billion annually; $25,000 to $55,000 per episode

We continue to be excited about our mission and know that ZuragenTM may have tremendous application and potential to improve the care and outcomes of patients requiring the use of vascular devices no matter what the healthcare setting (dialysis, acute care, outpatient, etc.) may be.

We remain optimistic that we can complete patient enrollment by this summer (June 15, 2007 target). With the weekly enrollment trends, addition of 10 new sites as well as the implementation of the “best practices” that were shared at the meeting we feel there is very strong momentum.

You have our commitment to provide you with the resources and tools you need to successfully execute the AZEPTIC Trial. Please don't hesitate to contact us if there is anything we can assist you with.

Thank you again for your commitment, hard work and time. We are confident your efforts are making a difference!

 

AZEPTIC Trial
2007 Educational Incentive Program

 
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.

 

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 if you think of any useful additions to the website, or have any feedback!