|
 The
Emergency Department at Pennsylvania Hospital has developed
a robust and broad-ranging clinical research program. Administered
by Pamela
Henderson, BSN, RN, our research
projects include some that are based in the ED and others
in which the primary responsibility for the clinical care
of the patients is shared with other specialists.
Current projects
include:
| Study: |
A Randomized, Multicenter, Blinded
Study of the Efficacy and Safety of High-Dose (750mg),
Short-Course (3-5 days) Levofloxacin Therapy in Uncomplicated
and Complicated Acute Bacterial Exacerbation of Chronic
Bronchitis |
| Sponsor: |
Ortho-McNeil Pharmaceuticals |
| PAH
Investigators: |
Charles
V. Pollack, Jr., MA, MD, FACEP
Susan A. Gregory, MD, FACP, FACCP |
| Rationale: |
Levfloxacin given once daily has been
studied in multiple large clinical trials and doses
of 500mg once daily for seven days resulted in safe
and effective treatment of ABECB. Since levofloxacin
is a concentration-dependent killing antibacterial
it is expected that high-dose, short course treatment
will successfully treat ABECB. Several factors argue
in favor of reducing therapy to the shortest duration
that is effective and these include cost, improved
compliance, and the total number of potential adverse
events. An additional reason, however, may be equally
important. Years of antibacterial use have indicated
that resistance development is most closely associated
with the amount of drug used. Therefore, it is expected
that a higher dose, shorter course treatment will help
prevent the emergence of resistance.
This is a Phase 3B protocol in which patients with both uncomplicated
and complicated (the differentiation based on validated clinical criteria)
acute bacterial exacerbation of chronic bronchitis (ABECB) will be studied.
The primary objective of this study for the uncomplicated ABECB severity
group is to establish the clinical efficacy and safety of high-dose,
short-course levofloxacin compared to azithromycin.
The primary objective of this study for the complicated ABECB severity
group is to establish the clinical efficacy and safety of high-dose,
short-course levofloxacin compared to amoxicillin/clavulanate.
|
[back
to top]
| Study: |
An Epidemiological Observational Study
of Deep Vein Thrombosis (DVT) |
| Sponsor: |
Genecom |
| PAH
Investigators: |
Charles
V. Pollack, Jr., MA, MD, FACEP
Shane
Edward Ruckle, MD
Paul Anthony Andrulonis, Jr., MD |
| Rationale: |
DVT is a significant public health
problem with the potential both for significant morbidity
(DVT with loss of productivity, post-phlebitic syndrome)
and for mortality (pulmonary embolism). This study
is an epidemiological survey of approximately 7500
patients in comprehensive effort to establish a DVT
registry and to study DVT and its treatment. It will
provide historical data on patients, including demographic
information, risk factors and prophylaxis measures.
It will also provide direction for focusing the future
prevention initiatives.
Dr. Pollack serves on the Steering Committee of the DVT-FREE Initiative.
|
[back
to top]
| Study: |
Sixteenth Multicenter Airway Research
Collaboration (MARC-16) |
| Sponsor: |
Abbott Pharmaceuticals |
| PAH
Investigators: |
Charles
V. Pollack, Jr., MA, MD, FACEP
Shane
Edward Ruckle, MD
Paul
Anthony Andrulonis, Jr., MD |
| Rationale: |
Large-scale ED-based research on CAP
is lacking, despite at least 2 million CAP-related
visits to US EDs each year. Furthermore, much of the
existing pneumonia data ignores the research questions
pertinent to the ED population and the distinct characteristics
of practice in this setting. These characteristics
have significant impact on the use of care plans to
improve care. There is a pressing need to support ED-based
CAP research in a variety of topic areas, such as diagnosis
and treatment (e.g., utility of diagnostic tests, accuracy
of test interpretation, selection and timing of antimicrobial
treatments, admission and discharge criteria), prevention
(e.g., influenza vaccination and treatment), education,
and economic evaluation (e.g., drug choice and health
outcome, health care utilization, etc).
This study will evaluate the resistance patterns of Streptococcus pneumoniae
organisms cultured in sputum samples and evaluate the clinical response
to treatment with Biaxin XL.
|
[back
to top]
| Study: |
Can Rapid Risk Stratification of Unstable
Angina Patients Suppress Adverse Outcomes with Early
Implementation of the ACC/AHA Guidelines: The CRUSADE
National Quality Improvement Initiative |
| Sponsor: |
Duke Clinical Research Institute |
| PAH
Investigators: |
Charles
V. Pollack, Jr., MA, MD, FACEP
Shane
Edward Ruckle, MD
Paul
Anthony Andrulonis, Jr., MD
Howard
L. Haber, MD, FACP, FACC |
| Rationale: |
The optimal evaluation and
management strategies for patients with acute
coronary syndrome
who do not have ST-segment elevation continue
to evolve. In response to an explosive increase
in studies of
these patients and their outcomes over the
past several years, the American College
of Cardiology (ACC) and
American Heart Association (AHA) published
in September of 2000 an extensive treatment
guideline for these
patients. Initial feedback from emergency
physicians, cardiologists, and hospitals
indicates that the guidelines
are not being closely followed. This is particularly
important in the care of patients objectively
identified as being “high risk”:
those with new ST-segment depression, an
extended duration or accelerated pace
of angina, sustained ventricular ectopy,
advanced age, or with elevated cardiac troponin
levels. CRUSADE is
a national quality improvement initiative
aimed at monitoring compliance with the ACC/AHA
guidelines,
for high-risk patients, over time. CRUSADE
hospitals will also be offered educational
materials (site reports,
comparative reports, educational conferences,
etc) to assist in improving compliance.
Dr. Pollack serves on the Executive Committee of the CRUSADE Initiative.
|
back
to top]
| Study: |
A Double-Blind, Placebo-Controlled,
Parallel, Multicenter Study on Extended VTE Prophylaxis
in Acutely Ill Medical Patients with Prolonged Immobilization |
| Sponsor: |
Aventis Pharmaceuticals |
| PAH
Investigators: |
Charles
V. Pollack, Jr., MA, MD, FACEP
Susan A. Gregory, MD, FACP, FACCP
Howard
L. Haber, MD, FACP, FACC
David
C. Chang, MD
Dara
G. Jamieson, MD
R.
Michael Buckley, Jr., MD
Judy
A. Somers, MD
Kathleen
Nasci, MD
Paul
Anthony Andrulonis, Jr., MD
Shane
Edward Ruckle, MD |
| Rationale: |
VTE is a major public health concern
in medically ill immobilized patients. In several other
studies, LMWH has been show to significantly reduce
the incidence of DVT, but it is likely that the standard
treatment duration of 10+/-4 days may be too brief
for some patients and that it is discontinued while
they are still at risk for DVT. An extension of the
prophylaxis may result in further risk reduction of
VTE in medically ill patients.
This study will evaluate the efficacy and safety of extended VTE prophylaxis
with enoxaparin for 28+/-4 days compared to placebo, both following 10+/-4
days of initial treatment with enoxaparin.
|
[back
to top]
| Study: |
Clinical Protocol for Evaluating
the Distribution of Albumin Cobalt (ACB‘)
Test Results in Patients with Conditions
Other Than Ischemic Heart
Disease |
| Sponsor: |
Ischemia Technologies |
| PAH
Investigators: |
Charles
V. Pollack, Jr., MA, MD, FACEP
Judy
A. Somers, MD
Kathleen
Nasci, MD
Paul
Anthony Andrulonis, Jr., MD
Shane
Edward Ruckle, MD |
| Rationale: |
There are well-accepted
biochemical markers for cardiac necrosis
which are used to aid
in the diagnosis of myocardial infarction.
However, there are no proven and accepted
biochemical markers
for ischemia. The Albumin Cobalt Binding
Test (ACB Test‘), is under investigation
as a biochemical marker for ischemia. Although
the sensitivity of the
ACB test in detecting ischemia-modified
albumin in patients with coronary ischemia
appears to be high,
the specificity requires further investigation.
This clinical study is designed to characterize
the distribution
of ACB Test results in individuals with
diseases other than ischemic heart disease,
with particular emphasis
on other ischemic conditions, and other
conditions which might masquerade as ischemic
heart disease or
acute cardiac ischemia.
*We expect to begin this protocol
in the near future.
|
[back
to top]
| Study: |
A Prospective, Open-Label, Randomized,
Parallel-Group Investigation to Evaluate the Safety
of Enoxaparin Versus Unfractionated Heparin in Subjects
who Present to the Emergency Department with Acute
Coronary Syndrome |
| Sponsor: |
Aventis Pharmaceuticals |
| PAH
Investigators: |
Charles
V. Pollack, Jr., MA, MD, FACEP
Shane
Edward Ruckle, MD
Paul
Anthony Andrulonis, Jr., MD |
| Rationale: |
This study will evaluate patients
who present to the ED and are diagnosed with non-ST
segment elevation ACS, including unstable angina and
non-ST-segment elevation MI. Therapy for these conditions
has evolved over the last decade and several studies
have shown the superiority of combined antiplatelet
and anticoagulant treatment over antiplatelet therapy
alone. Enoxaparin has been approved in the US for prevention
of ischemic complications in USA and non-Q-wave MI,
but it is not widely used in the ED setting. This study
will compare the efficacy and safety of enoxaparin
and unfractioned heparin in this patient population.
*We expect to begin this protocol in the near future.
Dr. Pollack is the national co-PI for RESCUE-ACS.
|
[back to top]
|
 |
