Pediatric Fungal Network - ISHAM

PFN
Pediatric
Fungal
Network
William J. Steinbach, MD
Duke University
Director
Dedicated to Understanding Pediatric Invasive Fungal
Infections and Antifungals Through Global Collaboration
November 2, 2006
Coordination Center
Box 3499
Duke University Medical Center
Durham, NC 27710 USA
Tel: +1 (919) 684-3734
Fax: +1 (919) 681-8934
http://pfn.pediatrics.duke.edu
Daniel K. Benjamin, Jr., MD MPH PhD
Duke University
Co-Director
Thomas J. Walsh, MD
National Cancer Institute
Co-Director
United States Sites
Baylor College of Medicine
Case Western Reserve University
Children’s Hospital of Austin
Children’s Hospital of Los Angeles
Children’s Hospital of Oakland
Children’s Hospital of Orange County
Children’s Hospital of Philadelphia
Children’s Hospital of Pittsburgh
Children’s Hospital of San Diego
Children’s National Medical Center
Cincinnati Children’s Hospital
Duke University
National Cancer Institute
Northwestern University
Stanford University
St. Jude Children’s Hospital
University of Arkansas
University of California-Irvine
University of Colorado
University of Florida
University of Miami
University of Rochester
University of South Florida
University of Texas Southwestern
University of Wisconsin
Vanderbilt University
International Sites
Hospital of Sick Children
Johann Wolfgang Goethe University
Sydney Children’s Hospital
University of Genova
University of Heidelberg
University of Helsinki
University of Muenster
University of Nijmegen
University of Tartu
University of Thessaloniki
Dear Pediatric Fungal Network Investigators,
There has been tremendous interest, excitement, and progress in the Pediatric Fungal
Network (PFN). This network is constructed as a multi-center, multi-national cohesive
collection designed to harness the intellectual power of the worldwide community and
synergistically develop advances for children with invasive fungal infections. The primary
mission of the PFN is to gain a more complete understanding of the scope and character of
pediatric invasive fungal infections – epidemiology, diagnosis, treatment, and outcome –
through this coordinated network of scientific investigation.
This consortium was founded on two guiding principles. First, if one wants to advance
understanding and outcomes in pediatric disease, one needs to have pediatricians lead the
charge. History has repeatedly shown that relying on investigators who do not routinely
care for children to adequately and accurately fully portray the nuances and unique
attributes of pediatric disease and outcomes is not an effective strategy. Secondly,
meaningful work will only occur through multi-center, multi-national collaboration of
dedicated investigators as the investigative power of individual sites or a smaller collection
of sites is limited. The PFN is therefore composed of researchers who are fundamentally
frustrated with the current inadequate knowledge of invasive fungal infections in children
and neonates and have united to change the landscape.
This is a bold concept and the PFN is therefore an innovative revolution in the field.
All of you have uniformly agreed that only through collaboration will we achieve our
goals, but like all great leaps in progress that require new thinking, this will take time to
fully mature and yield the data we need to advance the care of children.
In addition to advancing our understanding of the fundamental and yet fully
unrecognized epidemiology of pediatric invasive fungal infections, the PFN will serve as
an effective vehicle of cohesive centers to conduct ground-breaking diagnostic and
therapeutic clinical trials focused on pediatric fungal infections, diagnostic surrogates, and
antifungals. The PFN is the ideal vehicle and positioned as unique and unparalleled in the
field. We have already begun discussions with interested sponsors for such ventures.
At present the PFN is growing daily and consists of 26 sites in the United States and
10 sites internationally. The PFN website can be found at: http://pfn.pediatrics.duke.edu.
On that website can be found a description of the PFN vision and lists of investigators and
sites. The website is updated frequently but may still be missing a few colleagues not yet
added. Please review the website and send any comments for improvement directly to me.

Investigators
2 November 2006
Page 2
Additionally, if you know of interested colleagues at other centers who are interested in joining the
group, please have them email me. The website will also be the location for entry of clinical data through
an electronic CRF (eCRF) format. This capability is not easily evident now on the website, but the
infrastructure has already been designed. In the future you all will acquire usernames and passwords for
access to the data entry aspects.
It was thought that the first projects for such a new network should focus on gathering fundamental
epidemiologic information, for only through accurate collection of this data will we be positioned to
effectively design the future clinical trials in the field. In order to start smaller and allow room for
growth, we think infections with both Candida and Aspergillus would capture most of the relevant
patients. We have constructed steering committees for the two types of infections, and the chairman for
the Candida group is Theo Zaoutis (Children’s Hospital of Philadelphia) and for the Aspergillus group it
is Bill Steinbach (Duke University). The steering committees for each project are charged to develop an
effective, concise (likely 3 pages maximum), eCRF to capture the data. Based on previous known
interests we have selected several individuals from the PFN to sit on those committees, but please email
the two chairs if you are also interested in participating in the eCRF development phase. The studies
themselves will begin after eCRF development. Many of the involved investigators and sites have
clinical research coordinators who are working on other related projects who are able to enter in the data
for an additional eCRF for these studies. For those sites without such a resource, a concise and simple
eCRF will be quite beneficial. There will also likely be the requirement for IRB approval at many
centers for a prospective observational epidemiologic study, and we will send an already approved IRB
template to all of you for use in drafting your own institution’s IRB documents.
As mentioned earlier, at present the PFN does not have the funding to pay investigators or sites on a
per-patient recruitment basis. This work is being done by all of us for the chance to dramatically alter the
field in a novel fashion as well as the many opportunities for analysis and publication of the data. The
data we accumulate will be unprecedented in scope and will be spread around the interested investigators
who want to analyze aspects of it for publication. In the future we will devise a publication scheme so
the data is optimally used by all. Initial funding has been secured for the website and administrative tasks
(future conference calls, mailings, etc). I have also successfully gathered additional funding promises
from other companies and am currently lobbying other organizations (foundations, CDC, NIH, etc.) for
additional assistance. To date this consortium has been very well-received by all.
The PFN will operate as a democracy of colleagues who all have common goals. Future conference
calls will be scheduled for the current and future working groups and we invite all comments and
thoughts on how to best achieve our goals.
Sincerely,
Bill Steinbach
On behalf of the Pediatric Fungal Network