Zuragen™ Clinic Poster
Local Article Example
Q & A
Educational Incentive Program
CRF Re-order Form
CRF Helpful Hints
Hemodialysis Catheter (Material) Types
Temperature Conversion Chart
Issue 8, September 21, 2007
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.
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)
|Dr. Fadem, Houston, TX (103)
|Dr. Rogers, Ocala, FL (104)
|Dr. Block, Denver, CO (105)
|Dr. Kopelman, Bakersfield, CA (106)
|Dr. Al-Makki, Lafayette, IN (107)
|Dr. Henriquez, Bronx, NY (108)
|Dr. Khwaja, Newport Beach, CA (109)
|Dr. Posner, Baltimore, MD (110)
|Dr. Roer, Waterbury, CT (111)
|Dr. Kapatkin, Brandon, FL (112)
|Dr. Halligan, Erie, PA (113)
|Dr. Abbott, Orlando, FL (114)
|Dr. Cheriyan, Fairfax, VA (115)
|Dr. Koeper, Appleton, WI (116)
|Dr. Herman, Buffalo, NY (117)
|Dr. Matalon, New York, NY (118)
|Dr. Williamson (119)
|Dr. Shetye (121)
|Dr. Cooper (122)
|Dr. Besarab (123)
|Dr. Germain (124)
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.
- 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.
- 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!
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
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.
Ash Access Technology, Inc. Team
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!