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Azeptic Trial Update
Issue 8, September 21, 2007

Fall Image

Tip of the Month


PLEASE be sure to discuss the AZEPTIC trial with your dialysis staff and provide appropriate guidance to assure the protocol is being followed. If additional in-service trainings are needed, please contact Sharon, Allie, Rita or your monitor.

CRF TIPS

Hints & Tips to Avoid Queries

  • Make sure you document at least the year for medical history, concomitant medications, etc. If you don’t know the correct date, please question the patient and/or family members. Prompting for at least a year is okay. For example, “do you think you’ve been taking this hypertension med for at least 10 years?” Document in the source as such and record 1997.
  • Documentation for amount of catheter lock used: if the patient is randomized to Zuragen™ (AAT-023), please record the total amount of Zuragen™ required to fill the catheter lumens plus .3 overfill. If randomized to heparin, please record the 5000 u of heparin PLUS the amount of normal saline used to the fill volume of the catheter lumens. Both need to be recorded in your source documents (i.e. dialysis flow sheets, progress notes, etc.) as well!
  • Please send completed queries directly to StatKing.
  • If you have a question when completing the CRFs or queries, please feel free to call either Averion or StatKing directly (see study contact sheet in the regulatory binder for phone and/or email contact information).

New Site Updates

Enrollment Progress As of 9/18/07
Please remember to send in your enrollment log each Friday
Dr. Hariachar, Hudson, FL (101)
40
Dr. Fadem, Houston, TX (103)
8
Dr. Rogers, Ocala, FL (104)
20
Dr. Block, Denver, CO (105)
4
Dr. Kopelman, Bakersfield, CA (106)
27
Dr. Al-Makki, Lafayette, IN (107)
15
Dr. Henriquez, Bronx, NY (108)
2
Dr. Khwaja, Newport Beach, CA (109)
48
Dr. Posner, Baltimore, MD (110)
3
Dr. Roer, Waterbury, CT (111)
34
Dr. Kapatkin, Brandon, FL (112)
7
Dr. Halligan, Erie, PA (113)
13
Dr. Abbott, Orlando, FL (114)
21
Dr. Cheriyan, Fairfax, VA (115)
4
Dr. Koeper, Appleton, WI (116)
8
Dr. Herman, Buffalo, NY (117)
15
Dr. Matalon, New York, NY (118)
24
Dr. Williamson (119)
4
Dr. Shetye (121)
0
Dr. Cooper (122)
9
Dr. Besarab (123)
4
Dr. Germain (124)
0
Total Randomized
310

Fun Stuff!

WHY DO LEAVES CHANGE COLOR IN THE FALL?
Plants make their own food. They take water from the ground through their roots, and carbon dioxide from the air. The water and carbon dioxide turn into food using sunlight and chlorophyll. Since chlorophyll is green, it gives leaves their green color. When the days start to get short and dry, many plants stop making food in the fall and the chlorophyll goes away. This is when we start to see the orange and yellow colors in the leaves. These colors were in the leaves all summer, but the green covered them up. Red leaves are actually ‘made’ in the fall from food trapped in the leaves. Brown colors are also made in the fall—this color comes from wastes left in the leaves.


Lab Reminders

  1. When sending samples to DaVita Labs, remember to use the original screening number for that particular subject. For example, RMR has met all preliminary Inclusion/Exclusion criteria. The screening number assigned to RMR is 1001. The patient is considered a screen failure because the patient’s screening cultures came back positive. The patient is started on antibiotics. After the 14-day wash out period, the patient is re-screened. The screening number on the enrollment log is 1007. However, when sending in the cultures to DaVita, you MUST use the original screening number, 1001. If you have questions, please let us know.
  2. Non-DaVita sites — please be sure to include an emergency contact phone number. This will assure that if the Lab has a question on the specimens submitted, they will be able to get in touch with the appropriate party. Thank you!

Remember!

The use of topical antibiotics at the catheter site is acceptable/approved by the medical monitors (dressing change). If the patient has a suspected exit site infection, once the swab of the exudates is collected for the culture specimen, the topical may be applied (this is similar to the process of giving the patient antibiotics once the blood culture samples are drawn).

 

From the Sponsor

While students are back in school hitting the books, we (Ash Access) have been busy trying to “hit” new milestones as an organization as well as in the AZEPTIC (Analysis of Zuragen™’s Efficacy in Preventing & Treating Infection in Catheters) Trial for Zuragen™. In June, Ash Access Technology received official FDA approval on a new long-term hemodialysis catheter (Ash Advance™) and shortly thereafter signed a commercial distribution agreement with a large medical device company to bring the asset to the market (press releases will be coming later this year and the product launched early next). We have now initiated 25 study sites in the AZEPTIC Trial, received approval from FDA for the addition of 4 more and just last week enrolled patient #314. GREAT JOB!!! We are very grateful for all of the exciting developments that have occurred this summer and are well aware that no milestone could be hit unless we have the “right” people and for that we again say THANK YOU.

As we head into the fall months we are hoping to make it the "homestreatch" for the study. We are confident that with the new sites up and running and additional enrollment from existing sites that we can realistically close patient enrollment in the October / November timeframe. We are asking for your continued commitment to help us "hit" this important enrollment milestone. In addition, we can't emphasize enough how crucial it is to ensure that the dialysis staff remain diligent in monitoring for key trial endpoints (CRBSI, patency) and that the appropriate lab work / CRFs are completed when and if an event occurs. We also know from our experience that a patient could be treated for a CRBSI or patency failure at a location outside of the dialysis unit (i.e. hospital, emergency room, etc.) and therefore would ask the PI / Study Coordinators to do their best to track down as much information as possible that pertains to study endpoints. Lastly, we continue to get positive feedback from the study monitors on the preparation, organization and cooperation from each site. As the pace of monitoring picks up over the next few months, we would greatly appreciate it if you could ensure the same level of productivity.

Finally, we would be remiss if we didn't emphasize the exciting, pioneering research we are asking you to participate in. The AZEPTIC Trial is an important ground breaking study that hopes to address the significant complications associated with the use of vascular access devices (i.e. catheters, PICCs, ports, etc.). The frequency and impact of these complications (infections and thrombosis) are staggering and the impact they have on a patient's quality of life and outcomes is astounding. Our recent attendance at key bio-tech / medical conferences (i.e. infectious diseases, vascular access, etc.) along with frequent discussions with key opinion leaders in the medical community reaffirm our belief in the innovation and potential of Zuragen™. Thank you again – your commitment and hard work are making a difference.

Best Regards,

Ash Access Technology, Inc. Team

 


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!