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March
2008: VOLUME
1, NUMBER 9
[Editor’s Note: Next week, we’ll be launching a survey via
e-mail; what you tell us will help shape future issues of eInfections
Review. Please look for the email, complete the survey, and enter to
win an iPod Shuffle from eInfections Review.]
Update
on New Antimicrobials
In
this Issue...
In the past few years, several
new antimicrobial agents have become available to treat a variety of
infections. An understanding of the indications and side-effects of
these new therapies as well as their advantages relative to older antimicrobial
agents is important for all providers. In this issue, we review two
new antibacterial agents (daptomycin and tigecycline), the echinocandin
class of antifungal agents, the role of rifaximin in the treatment and
prevention of travelers’ diarrhea, and retapamulin, a topical agent
for minor skin infections such as impetigo. |
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Course
Directors
John
G. Bartlett, MD
Professor of Medicine
Department of Medicine
The Johns Hopkins
University
School of Medicine
Baltimore, MD
Paul
G. Auwaerter, MD
Associate Professor
of Medicine
Clinical Director
Division of Infectious
Diseases
The Johns Hopkins
University
School of Medicine
Baltimore, MD
Sara
E. Cosgrove, MD, MS
Assistant Professor
of Medicine
Division of Infectious
Diseases
Director
Antibiotic Management
Program
Associate Hospital
Epidemiologist
The Johns Hopkins
University
School of Medicine
Baltimore, MD |
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GUEST
AUTHOR OF THE MONTH |
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Commentary
& Reviews: |
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Sara
E. Cosgrove, MD, MS
Assistant
Professor of Medicine
Division
of Infectious Diseases
Director
Antibiotic
Management Program
Associate
Hospital Epidemiologist
The Johns
Hopkins University
School
of Medicine
Baltimore,
MD |
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Guest
Faculty Disclosures
Sara
E. Cosgrove, MD, MS has disclosed that she has received grants
or research support from Merck and served on the Advisory Boards
for Ortho-McNeil, Cadence Pharmaceuticals, and Theravance/Astellas.
Unlabeled/Unapproved Uses
The author has indicated
that there will be reference to unlabeled or unapproved uses of the
drug retapamulin in the presentation.
Program
Directors' Disclosures |
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At
the conclusion of this activity, participants should be able to:
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Discuss
with colleagues the indications for and side effects of two new
antibiotics: daptomycin and tigecycline |
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Discuss
with colleagues the indication for and side effects of the echinocandin
class of antifungals |
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Discuss
with colleagues the indications for two new non-systemic antimicrobial
agents: rifaximin and retapamulin |
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COMPLETE
THE
POST-TEST
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1.
Click on the appropriate link
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Johns Hopkins on-line course, login. Otherwise, please register.
Step
3.
Complete the post-test and course
evaluation.
Step
4.
Print out your certificate.
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Daptomycin
is a novel lipopeptide antibiotic with rapid bactericidal activity
against Gram-positive organisms, particularly Staphylococcus aureus.
It was initially FDA-approved for the treatment of skin and soft tissue
infections at a dose of 4 mg/kg daily. The study by Fowler et al (reviewed
herein) demonstrates that daptomycin at a dose of 6 mg/kg daily is
not inferior to standard therapy, which is defined as antistaphylococcal
penicillins or vancomycin, both with initially combined low-dose gentamicin,
for the treatment of S. aureus bacteremia and right-sided
endocarditis. While antistaphylococcal penicillins (eg, oxacillin and
nafcillin) remain the antibiotics of first choice for methicillin-susceptible S.
aureus (MSSA) bacteremia and endocarditis, daptomycin is a reasonable
alternative to vancomycin for patients with MSSA bacteremia, severe
penicillin allergy, or MRSA bacteremia. Its major limitations include
an apparent propensity towards emergence of resistance during therapy
of some deep-seated or poorly debrided infections, and the lack of
information regarding efficacy and safety in patients with creatinine
clearances below 30 ml per minute. Its major advantage is its once
daily dosing.
Tigecycline is a novel bacteriostatic
glycylcycline antibiotic derived from tetracyclines. It has a broad
spectrum of activity against most strains of staphylococci and streptococci
(including MRSA and vancomycin-resistant enterococci [VRE]), anaerobes,
and many Gram-negative organisms (with the exception of Proteus spp
and Pseudomonas aeruginosa). The studies by Babinchak et al
and Ellis-Grosse et al, reviewed in this issue, support the efficacy
of tigecycline for treatment of complicated intra-abdominal, skin, and
soft tissue infections. The major drawbacks of the drug when used for
its FDA-approved indications are its expense relative to other therapeutic
alternatives and the high incidence of nausea and vomiting associated
with its use. Caution should be exercised if tigecycline is used off-label
for highly resistant Gram-negative infections, given reports of high
failure rates for these pathogens.1 Although
not currently FDA-approved for community-acquired pneumonia, tigecycline
was found to be not inferior to levofloxacin. However, in data not yet
published, tigecycline failed to meet the criteria for non-inferiority
for treatment of hospital-associated and ventilator-associated pneumonia
when compared to imipenem-cilastatin.
The echinocandins (caspofungin,
mycafungin, and anidulafungin) are a novel class of intravenous antifungal
agents with excellent fungicidal activity against Candida albicans and
most other Candida species. The mean inhibitory concentration (MIC)
of echinocandins for C. parapsilosis isolates tend to be higher
than for other Candida species, and some experts recommend using caution
when using echinocandins to treat C. parapsilosis. The newer
echinocandins, mycafungin and anidulafungin, recently joined caspofungin
as FDA-approved agents for the treatment of candidemia; there are no
major differences between the three agents.2 The
study by Reboli et al (reviewed herein) demonstrates that one of the
agents, anidulafungin, was not inferior and perhaps superior to fluconazole
for the treatment of invasive candidiasis. This latter observation is
a matter of some controversy, given that fluconazole has been used successfully
for many years for the treatment of candidemia, has the benefit of being
relatively inexpensive, and available in a highly bioavailable oral
formulation. Nonetheless, the sickest patients with candidemia should
probably be treated initially with echinocandins, with a switch to fluconazole
after the patients stabilize.
Rifaximin is an oral, but non-absorbed,
derivative of rifamycin. It is FDA-approved for the treatment of non-invasive Escherichia
coli-associated travelers’ diarrhea at a dose of 200 mg, 3 times
daily, for 3 days. The study by DuPont et al, in this issue, shows that
it is also effective for prevention of travelers’ diarrhea in Mexico.
The advantage of rifaximin is that it provides a non-systemic antibiotic
option for treatment and prevention of travelers’ diarrhea, although
the cost of a longer course of therapy is considerable. However, rifaximin
should not be used if there is concern for systemic infection in a traveler
with diarrhea. Further, additional studies are needed to determine its
efficacy in persons traveling to Asia.
Retapamulin is a novel antibiotic
only available in topical formulation. It has activity against staphylococci
(including MRSA) and streptococci and does not appear to have cross-resistance
with other antibiotics, including mupirocin. It has been FDA-approved
for treatment of impetigo due to MSSA or S. pyogenes based
on a double-blind, randomized, placebo controlled study that included
children ≥ 9 months (78%) and adults (22%).3 Patients
with impetigo were randomized to receive retapamulin or placebo, both
applied twice daily for 5 days. In the clinical per protocol population,
retapamulin-treated patients had a 90% success rate versus a 36% success
for placebo-treated patients at the end of therapy. A similar difference
was seen at the follow-up visit 9 days after the end of treatment. In
the study by Parish et al in this issue, retapamulin was also found
to be effective therapy for secondarily infected dermatitis when compared
to systemic antimicrobial therapy using oral cephalexin. The use of
topical agents for minor skin infections allows for avoidance of systemic
antimicrobial therapy, which can be associated with side effects and
development of resistance.
The discovery and development
of antibiotics is one of the success stories of modern medicine. Countless
lives have been saved since the introduction of penicillin in the 1940's.
However, the past decade has witnessed impressive increases in rates
of resistance to antimicrobials in both the hospital and the community.
Unfortunately, the discovery, testing, and FDA approval of novel antimicrobial
agents has diminished dramatically during the same time period. Given
these developments, appropriate use of currently available antimicrobial
agents is increasingly important.
References
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DAPTOMYCIN
FOR S. AUREUS BACTEREMIA AND RIGHT-SIDED ENDOCARDITIS |
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Fowler
VG, Boucher HW, Corey GR, et al, for the S. aureus Endocarditis
and Bacteremia Study Group. Daptomycin versus standard
therapy for bacteremia and endocarditis caused by Staphylococcus
aureus. N Engl J Med. 2006; 355:653-665.
(For non-journal subscribers, an additional fee may apply
for full text articles.) |
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In
an open-label randomized controlled trial, the authors studied adult
patients with S. aureus bacteremia with or without endocarditis
who were treated with either daptomycin (6 mg/kg daily) or standard
therapy consisting of initial low-dose gentamicin plus either an
antistaphylococcal penicillin or vancomycin. Patients were ineligible
for enrollment if they had a creatinine clearance <30 ml per minute,
osteomyelitis, potentially infected hardware, or pneumonia (daptomycin
is inactivated by pulmonary surfactant and cannot be used to treat
pneumonia). The primary outcome was treatment success 42 days after
therapy was completed.
Two-hundred-thirty-five
patients were included in the modified intent-to-treat analysis:
53 of the 120 (44%) patients who received daptomycin and 48 of 115
(42%) who received standard therapy were treatment successes. These
results met the prespecified criteria for non-inferiority of daptomycin
relative to standard therapy. Results were similar in the subgroups
of patients with complicated bacteremia, right-sided endocarditis,
and MRSA infection. Sixteen percent of patients who received daptomycin
failed because of persisting or relapsing S. aureus infection,
compared to 10% of patients who received standard therapy. Six of
the patients in the daptomycin group had emergence of resistance
to daptomycin and treatment failure; most of these patients had deep-seated
and/or undrained foci of infection. Fifteen percent of patients who
received standard therapy failed because of treatment-limiting adverse
events, compared to 7% of patients who received daptomycin. Most
of the additional failures in the standard therapy arm were attributable
to renal adverse events, likely due to the fact that 93% of these
patients received initial low dose gentamicin. Also of note is that
all patients with left-sided endocarditis caused by MRSA, regardless
of the agent that they received, failed therapy.
Daptomycin is not
inferior to standard therapy for the treatment of S. aureus bacteremia
and right-sided endocarditis. It should be used with caution in patients
with deep-seated infections (such as epidural abscess) or undrained
infections, given the risk of emergence of resistance to the drug.
Although daptomycin is in general well tolerated, patients should
be screened for muscle pain and have creatine kinase (CK) levels
checked at least weekly, as myopathy is a rare side-effect of the
drug. It should not be used to treat pneumonia because it is inactivated
by pulmonary surfactant. Finally, daptomycin has not been studied
in patients with creatinine clearances <30 ml per minute, including
patients on dialysis; if used in this population, the dose is 6 mg/kg
every other day, and patients should be monitored carefully for both
evidence of treatment failure and myopathy. |
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TIGECYCLINE
FOR INTRA-ABDOMINAL, SKIN, SOFT TISSUE, AND MULTIDRUG-RESISTANT GRAM-NEGATIVE
INFECTIONS |
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Babinchak
T, Ellis-Grosse E, Dartois N, et al. The efficacy and safety
of tigecycline for the treatment of complicated intra-abdominal
infection: analysis of pooled clinical trial data. Clin
Infect Dis. 2005; 41:S354-S367.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
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Ellis-Grosse
EJ, Babinchak T, Dartois N, et al. The efficacy and safety
of tigecycline in the treatment of skin and skin-structure infections:
results of 2 double-blind phase 3 comparison studies with vancomycin-aztreonam. Clin
Infect Dis. 2005; 41:S341-S353.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
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Babinchak
et al pooled data from 2 doubled-blind, randomized controlled trials
comparing tigecycline to parenteral imipenem-cilastatin for complicated
intra-abdominal infections, defined as post-operative abscess, perforated
appendix ± abscess, perforated diverticulitis ± abscess, complicated
cholecystitis (with perforation, empyema, or gangrene), perforated gastric
or duodenal ulcer, or small or large intestine perforation ± abscess.
All patients were required to undergo a surgical procedure in addition
to antibiotics. Antibiotics were given for 5 to 14 days. The primary
endpoint was clinical response 12 – 42 days after therapy. Patients
in the microbiologically-evaluable modified intent-to-treat population
(n=1262) received a mean of 8 days of therapy. Clinical cure rates were
86% for both tigecycline and imipenem-cilastatin. Tigecycline therapy
was more often associated with nausea (24% vs 19%) and vomiting (19%
vs 14%).
Ellis-Grosse et al pooled data
from 2 doubled-blind, randomized controlled trials comparing tigecycline
to vancomycin plus aztreonam in hospitalized adults with complicated
skin and skin structure infections that involved deep soft tissue, including
cellulitis at least 10 cm in width or length, required surgery, or were
associated with significant underlying disease such as diabetes, peripheral
vascular disease, or venous insufficiency. Antibiotics were given up
to 14 days. The primary endpoint was clinical response at the test-of-cure
visit. Patients in the clinically-evaluable population (n=833) received
a mean of 8 days of therapy. The most common diagnosis was deep tissue
infection with cellulitis, occurring in two-thirds of patients. Only
a small number of patients had MRSA infections. Clinical cure rates
were 87% for tigecycline and 89% for vancomycin plus aztreonam. Tigecycline
therapy was more often associated with nausea (35% vs 8%) and vomiting
(20% vs 4%).
These studies supported FDA approval
of tigecycline for skin and soft tissue infections and complicated intra-abdominal
infections, and demonstrated that tigecycline is reasonable single-agent
therapy for these infections, provided that there is not a strong suspicion
for P. aeruginosa (given this agent’s lack of activity against
that organism). Because tigecycline is a novel agent, there was initial
excitement that it may be useful in the treatment of infections due
to highly resistant Gram-negative organisms such as Acinetobacter
baumanii; however, experience in this area has been disappointing.
Tigecycline has low mean peak serum concentrations and poor urinary
penetration, making it a suboptimal choice for bacteremia and urinary
tract infections. Clinical failures have also been associated with higher
pre-therapy MICs of implicated organisms, as well as with the emergence
of resistance during therapy. Salvage therapy using tigecycline for
multidrug-resistant Gram-negative infections and VRE infections should
be done with caution and in consultation with an infectious diseases
specialist. |
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ECHINOCANDINS
FOR INVASIVE CANDIDIASIS |
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Reboli
AC, Rotstein C, Pappas PG, et al, for the Anidulafungin Study Group. Anidulafungin
versus fluconazole for invasive candidiasis. N Engl
J Med. 2007:356:2472-2482.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
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Reboli
and colleagues performed a randomized, double-blind trial comparing
anidulafungin with fluconazole for treatment of invasive candidiasis
(either candidemia or Candida spp. isolated from a sterile
site). Patients received anidulafungin or fluconazole (800 mg IV initially,
then 400 mg daily) for 14 – 42 days, and could be switched to
oral fluconazole after 10 days in both arms of the study. Patients were
excluded if they had recent prophylactic azole therapy, endocarditis,
osteomyelitis, meningitis, or C. krusei infection (the organism
is intrinsically resistant to fluconazole). The primary endpoint was
clinical and microbiological response at the end of IV therapy.
Two-hundred-forty-five patients
were included in the modified intention-to-treat analysis. The majority
of patients had candidemia (89%). Median duration of IV treatment was
14 days in the anidulafungin group and 11 days in the fluconazole group;
median duration of oral fluconazole was 7 days in the anidulafungin
group and 5 days in the fluconazole group. Ninety-six of 127 (76%) patients
who received anidulafungin and 71 of 118 (60%) patients who received
fluconazole had clinical and microbiological response at the end of
IV therapy. These results met the prespecified criteria for non-inferiority
of anidulafungin relative to fluconazole therapy; there was a significantly
greater response rate in the anidulafungin group. Patients in the fluconazole
group were more likely to have elevated transaminases relative to those
in the anidualafungin group (7% vs 2%).
This study demonstrates that
an echinocandin – anidulafungin – is not inferior to fluconazole in
the therapy of invasive candidiasis and is perhaps superior. Although
MICs of fluconazole for C. glabrata tend to be higher that
those for other Candida species, this did not seem to be a
reason for the additional fluconazole failures in the study. Instead,
the greatest difference was in outcomes of patients with C. albicans:
81% of anidulafungin patients had successful outcomes compared to 62%
of fluconazole patients. Although this finding may be due to subtle
differences in the two groups of patients (e.g. patients in the fluconazole
arm had more non-candidemia infections, less frequent removal of central
venous catheters, and there were more patients on immunosuppressive
therapy), the result is striking. Most experts now recommend the use
of echinocandins as first line therapy for patients with prior exposure
to fluconazole and in critically ill patients, a recommendation supported
by the results of this study. However, once a patient has had good clinical
response and has stabilized, a switch to oral fluconazole remains a
reasonable choice. Echinocandins do not penetrate well into the central
nervous system; thus, a complete ophthalmologic exam to assess for endophthalmitis,
recommended for all patients with candidemia, is of particular importance
in echinocandin-treated patients |
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RIFAXIMIN
FOR PREVENTION OF TRAVELERS’ DIARRHEA |
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DuPont
HL, Jiang Z, Okhuysen PC, et al. A randomized, double-blind,
placebo-controlled trial of rifaximin to prevent travelers’ diarrhea. Ann
Intern Med. 2005; 142:805-812.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
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DuPont
et al performed a randomized, double-blind, placebo-controlled trial
of rifaximin vs placebo for the prevention of travelers’ diarrhea in
adults. Participants were US students attending classes in Guadalajara,
Mexico, and living in local homes who presented to clinic with diarrhea.
They were assigned to 1 of 4 treatment groups for 2 weeks: rifaximin
200 mg daily, rifaximin 200 mg twice daily, rifaximin 200 mg 3 times
daily, or placebo 3 times daily. Participants kept a daily diary of
symptoms and if they developed diarrhea, stool specimens were collected.
The primary outcome measure was occurrence of diarrhea.
Two-hundred-ten patients were
evaluable. Rates of diarrhea were similar in all 3 rifaximin arms and
23 of 156 (15%) of these patients experienced diarrhea. In contrast,
29 of 54 (54%) of placebo-treated patients had diarrhea. Rifaximin provided
72% protection against traveler’s diarrhea. Rifaximin also protected
against mild diarrhea and non-diarrheal intestinal symptoms. No significant
adverse events were noted in any study arm. The majority of stool isolates
in all groups were enterotoxigenic E. coli. The MIC50 and
MIC90 for
coliform bacteria and Enterococcus spp were one dilution higher
in the rifaximin groups than in the placebo groups.
This study demonstrates that
rifaximin is beneficial for the prevention of travelers’ diarrhea. Given
the immediate (~ 24 hours of incapacitation) and long-term (persistent
irritable bowel symptoms in up to one-third of persons) consequences
of travelers’ diarrhea, such preventive strategies may be reasonable.
The advantage of rifaximin is that it is not absorbed and thus individuals
are not put at risk for the toxicities associated with systemic antibiotic
use, such as antibiotic resistance and antibiotic-associated diarrhea.
However, the finding in this study that there were small increases in
the MICs of rifaximin for stool flora deserves further attention. The
authors of the study also point out that while the drug seems to prevent
infections in Mexico, where most travelers’ diarrhea is caused by E.
coli, its efficacy in Asia, where pathogens such as Shigella, Salmonella and Campylobacter species
are more prevalent, has not been determined. |
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TOPICAL
RETAPAMULIN FOR IMPETIGO AND INFECTED DERMATITIS |
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Parish
LC, Jorizzo JL, Breton JJ, et al. Topical retapamulin ointment
twice daily for 5 days versus oral cephalexin twice daily for 10
days in the treatment of secondarily infected dermatitis: results
of a randomized controlled trial. J Am Acad Dermatol. 2006;
55:1003-1013.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
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Parish
et al performed a randomized, double-blind, double-dummy non-inferiority
trial to compare topical retapamulin for 5 days to oral cephalexin twice
a day for 10 days for the treatment of secondarily infected dermatitis
to determine if retapamulin can be used in lieu of systemic antimicrobials.
Patients (children ≥ 9 months and adults) had to have atopic dermatitis,
psoriasis, or allergic contact dermatitis, plus evidence of secondary
infection. The primary endpoint was the clinical response at follow-up
7-9 days after the end of therapy.
Four-hundred-seventy-six patients
were in the per-protocol clinical population and returned for a follow-up
visit; 275 of 320 (86%) of patients treated with retapamulin and 140
of 156 (90%) of patients treated with cephalexin had treatment success
at the follow-up visit. Results were similar in the intent to treat
analysis. Very few adverse events were reported that were felt to be
related to the study medications. The majority of patients in both treatment
groups reported that they preferred a topical therapy to an oral therapy
(61% in the retapamulin arm and 57% in the cephalexin arm).
This study demonstrates that
for patients with secondarily infected dermatitis, topical retapamulin
for 5 days was not inferior to oral cephalexin for 10 days and that
patients preferred topical therapy. In an era of increasing antimicrobial
resistance, avoidance of systemic antimicrobials whenever possible is
critically important and can be facilitated by the use of retapamulin
and other topical treatment approaches. Recent attention to community-acquired
MRSA skin infections has only heightened concern in patients and providers,
and has presumably led to more systemic antimicrobial use, even for
minor infections (such as impetigo and infected dermatitis) that in
most cases do not require systemic antibiotic therapy. Although retapamulin
is not FDA-approved for MRSA infections (only MSSA infections), it has in
vitro activity against MRSA and would likely be adequate therapy
for minor MRSA skin infections. Hopefully, additional studies will be
performed to address its efficacy against MRSA. |
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Johns Hopkins University School of Medicine is accredited by The
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activity has been developed for the Primary Care Physician, Internist,
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| Learning
Objectives — back
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At
the conclusion of this activity, participants should be able to:
|
|
Discuss
with colleagues the indications for and side effects of two new
antibiotics: daptomycin and tigecycline |
|
|
|
Discuss
with colleagues the indication for and side effects of the echinocandin
class of antifungals |
|
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|
Discuss
with colleagues the indications for two new non-systemic antimicrobial
agents: rifaximin and retapamulin |
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| Internet
CME Policy — back
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The
Office of Continuing Medical Education (CME) at The Johns Hopkins
University School of Medicine is committed to protect the privacy
of its members and customers. The Johns Hopkins University SOM CME
maintains its Internet site as an information resource and service
for physicians, other health professionals and the public.
Continuing Medical
Education at The Johns Hopkins University School of Medicine will
keep your personal and credit information confidential when you participate
in a CME Internet based program. Your information will never be given
to anyone outside of The Johns Hopkins University School of Medicine's
CME program. CME collects only the information necessary to provide
you with the services that you request. |
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As
a provider accredited by The ACCME, it is the policy of The Johns
Hopkins University School of Medicine to require the disclosure
of the existence of any significant financial interest or any other
relationship a faculty member or a provider has with the manufacturer(s)
of any commercial product(s) discussed in an educational presentation.
The Program Directors reported the following:
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John
G. Bartlett, MD has disclosed that he has served on
the HIV Advisory Board for GlaxoSmithKline, Abbott, Bristol-Myers
Squibb, Pfizer and Tibotec. He is also on the Policy Board for
Johnson & Johnson. |
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Paul
G. Auwaerter, MD has disclosed that he has served as
a consultant for Novartis, Pfizer, Ortho-McNeil, Schering-Plough,
and Genzyme. He is on the Speakers' Bureau for Schering-Plough
and has also disclosed that he is a Stock Shareholder for Johnson &
Johnson. |
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Sara
E. Cosgrove, MD, MS has disclosed that she has received
grants or research support from Merck and served on the Advisory
Boards for Ortho-McNeil, Cadence Pharmaceuticals, and Theravance/Astellas. |
Guest
Author Disclosures |
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opinions and recommendations expressed by faculty and other experts
whose input is included in this program are their own. Use of The
Johns Hopkins University School of Medicine name implies review
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prescribing information of specific drugs or combination of drugs,
including indications, contraindications, warnings and adverse effects
before administering pharmacologic therapy to patients. |
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©
2008 JHUSOM and eInfections Review
Created by DKBmed. |
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COMPLETE
THE
POST-TEST
Step
1.
Click on the appropriate link below. This
will take you to the post-test.
Step
2.
If you have participated in a Johns Hopkins
on-line course, login. Otherwise, please register.
Step
3.
Complete the post-test and course evaluation.
Step
4.
Print out your certificate.
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