A team of University of South Florida researchers hopes to treat severe staph infections
in the hospital and home by using a simpler and more efficient technique with far
less stress to patients than traditional treatment.
The treatment tested use of an antibiotic called dalbavancin — also known under its
brand name, Dalvance — as a possible alternative to antibiotics that must be administered
intravenously over weeks and even months. The drug shows promise in fighting Staphylococcus
aureus bacteria, the leading cause of death by bloodstream infections worldwide.
The study included evaluating patients with MRSA, or Methicillin-resistant Staphylococcus
aureus, an especially severe form of staph infections that resist treatment with many
standard antibiotics.
The multi-site study, published today in the Journal of the American Medical Association, found dalbavancin to be as safe and effective as the current standard of care for
treatment of complicated staph infections, said Kami Kim, MD, professor of medicine
and director of the Division of Infectious Disease and International Medicine in the
USF Health Morsani College of Medicine.
“Severe staph needs to be treated for a prolonged period, and we have a new choice
for the final weeks of treatment that doesn’t require an indwelling line and is more
convenient for patients,’’ Dr. Kim said. “In the past, some of these patients would
have to stay in the hospital for their duration of treatment because there were no
safe options to treat outside a hospital setting.’’
Along with its medical potential, the new option takes only 30 minutes to administer
intravenously and could significantly reduce treatment costs, Dr. Kim added.
“This should decrease the length of stay in the hospital, especially for individuals
who don’t have health care coverage,’’ Dr. Kim said. “So, we have an alternative that
should be safe, effective and more convenient for patients. It should also decrease
costs and increase hospital capacity because of shorter lengths of stays.’’
USF and Tampa General Hospital were one site for a national clinical trial funded by the National Institutes of Health and conducted by Duke University Clinical
Research Center and other academic medical centers across the country via the Antibacterial Resistance Leadership Group.
Dr. Kim served as site principal investigator at USF-TGH and is a co-author of the
JAMA article. She also is medical director of infectious disease at Tampa General
Hospital.
Dr. Kim recruited patients with serious staph who needed treatment, often four times
a day for six to eight weeks. They required a catheter and monitoring by a health
care provider. This demanding process can lead to additional infections and requires
frequent lab tests to monitor toxicities. Prolonged intravenous antibiotics can lead
to various complications, such as secondary infections and clots in the line, which
limit normal activities, such as swimming or bathing.
“The subjects we recruited (for dalbavancin) were delighted that they only needed
two more injections and could go home without an IV,’’ Dr. Kim said. “Of course, we
still monitored the subjects for the study, but in between these check-ins they could
go about their normal life.’’
Another USF Health professor of Infectious Disease, Kartik Cherabuddi, MD, chief hospital
epidemiology officer at Tampa General, also is a co-author of the JAMA paper.
“Complicated Staph aureus infections often strike people in their prime and have high
mortality,” said Dr. Cherabuddi. “Weeks of IV antibiotics, the usual treatment, are
difficult and risky, and this trial data shows Dalbavancin works just as well and
offers a practical alternative. It may improve patient compliance and outcomes in
real world practice.”
Dalbavancin is a long-acting cousin of vancomycin, a powerful “antibiotic of last
resort” often used when other antibiotics have failed. Dalbavancin is used to treat
acute bacterial skin and skin structure infections.
Because staph is a serious condition and not all infections are cured, hospitals will
need to choose, educate and monitor patients carefully.
“We hope there won’t be complications,’’ Dr. Kim said. “But patients will need to
maintain contact with their physicians to ensure they are cured.’’
While the study didn’t show dalbavancin to be superior to conventional therapy (the
control arm), it did show that using the drug in the final weeks of treatment is an
effective alternative. Patients got “usual” therapy while in the hospital until their
blood cultures were no longer positive.
In trials, the drug has shown high microbiologic success rates among trial subjects
with staph, and high clinical success rates within existing observational cohorts,
the team said. While the Food and Drug Administration has approved dalbavancin for
certain acute bacterial skin infections, it has yet to endorse it for the treatment
of complicated staph.
The medical team hypothesized that dalbavancin will be approved because of its similar
clinical efficacy to standard treatment with fewer adverse effects. Currently, an
individual dose of the drug is relatively expensive, Dr. Kim added, but most insurance
will pay if the drug is approved for more clinical indications.
“We don’t know if it will be approved for this, but hopefully it will,’’ Dr. Kim said.
“We’ll need to develop the infrastructure so that patients are followed and supported
as outpatients.’’
Photo by Ryan Rossy, USF Health Communications
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