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AAT-023 Clinical Trial Update
Issue 3, January 5, 2007

New Site Updates

Good News! The FDA has approved the addition of 10 study sites for a grand total of 20 sites. Currently we have qualified and initiated the following new sites:

  • Dr. Abbott in Orlando, FL
  • Dr. Roer in Waterbury, CT
  • Dr. Kapatkin in Brandon, FL
  • Dr. Halligan in Erie, PA

snowflakeWe are in the process of qualifying and initiating the additional sites and expect all to be up and running by the end of February, 2007. We expect enrollment to pick up from here and hope to have enrollment completed by the summer of 2007.

As we stated in the PI / Coordinator Teleconference earlier in September, we have set an aggressive goal to complete enrollment by the end of this calendar year and appreciate all of the hard work you are doing to make this a reality. Please let us know how we can continue to support your efforts as well as what tools and resources we could potentially develop to assist you in the process.

Tip of the Month
If a catheter is made up of two materials (polyurethane and polycarbonate), check both boxes on the CRF page


Save the Date!

Coordinator Meeting February 23-24, 2007
Swan and Dolphin Hotel The meeting will take place at the Walt Disney World Swan / Dolphin Hotel. The logistics are as follows:

Friday, February 23

Afternoon / Evening: Travel to Orlando, Florida Swan & Dolphin Hotel
Evening: Welcome Reception

Saturday, February 24

Meeting from 8:30 AMó3:30 PM to further discuss study updates, protocol execution, best practices, etc.


Amendment # 3 Approved
Updated version includes a change in antibiotic window!

Per the updated Protocol (v. 7.8), all listed antibiotics (see list below) are not allowed for 14 days prior to randomization. All other antibiotic therapy not on the list, including Vancomycin, must be completed 31 days prior to randomization.


Amoxicillin

           

Doxycycline

Amoxicillin/Clavulanate

 

Erythromycin

Ampicillin

 

Fluconazole

Azithromycin

 

Gentamicin

Cefazolin

 

Linezolid

Cefuroxime

 

Metronidazole

Cephalexin

 

Penicillin G

Ciprofloxacin

 

Sulfamethoxazole/Trimethoprim

Cindamycin

 

Tobramycin

 

CRF TIPS

Tips on Completing Page 8 - Baseline Medical Form

1. End Stage Renal Disease should not be captured here as this is being captured on the baseline demographic form.

2. The form asks for a diagnosis rather than symptoms. Please provide a specific diagnosis rather than symptoms. For example, shortness of breath, wheezing, dyspnea on exertion, productive cough, etc. are symptoms, whereas "bronchitis" is a definitive diagnosis.

3. For body system code 14, allergy, please do not provide symptoms of an allergy, such as hives, difficulty breathing, etc. Only the allergen itself should be recorded, such as a medication, food allergy or environmental allergy.

Reminder!
REMEMBER: When recording the pre- and post-dialysis vital signs, it is important to record the time the vitals were assessed, as well. If you are using electronic records, and there is not a place to record the time -- PLEASE ask your staff to record the time in the chart (as a progress note) or on the source document template provided for the study.


Enrollment Progress
Dr. Hariachar, Hudson, FL (101)
24
Dr. Stephanz, Provo, UT (102)
0
Dr. Posner, Baltimore, MD (103)
0
Dr. Rogers, Ocala, FL (104)
9
Dr. Block, Denver, CO (105)
4
Dr. Kopelman, Bakersfield, CA (106)
12
Dr. Al-Makki, Lafayette, IN (107)
5
Dr. Henriquez, Bronx, NY (108)
2
Dr. Khwaja, Newport Beach, CA (109)
27
Dr. Fadem, Houston, TX (110)
4
Dr. Roer, Waterbury, CT (111)
0
Dr. Kapatkin, Brandon, FL (112)
0
Dr. Halligan, Erie, PA (113)
0
Dr. Abbott, Orlando, FL (114)
0
Total Randomized
87

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

In case you haven't heard, Ash Access has named their clinical trial the AZEPTIC Trial: Analysis of Zuragen's Efficacy in the Prevention and Treatment of Infection In Catheters.

Recent resources have been sent to all participating sites:

  • Ash Access/AZEPTIC Trial T-shirts were sent at the end of December for participating Dialysis Staff.
  • AZEPTIC Patient Enrollment kits were sent to sites for all patients enrolled in the trial. The 'kits' consist of a tote bag with a fleece blanket, 'beanie' cap and stress squeeze ball inside. The tote bags are to be given to the subjects AFTER they are randomized into the study.

Please contact Dan Olson (dolson@ashaccess.com) of Ash Access with any questions.

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!