Newer, shorter-course antibiotic shows similar effectiveness for treating skin infection

February 12, 2013

Treatment with a newer antibiotic, tedizolid phosphate, once daily for 6 days was statistically noninferior (no worse than) in efficacy to the antibiotic linezolid twice daily for 10 days for both early (at day 2 to 3) and sustained (at day 11) clinical responses in patients with acute bacterial skin and skin structure infections, according to a study appearing in the February 13 issue of JAMA.

" available for treatment of complicated skin and skin structure infections (SSSIs) are generally efficacious, but and adverse effects limit their use. Linezolid, an oxazolidinone [a class of antibiotics], is the only approved for complicated SSSI caused by methicillin-resistant Staphylococcus aureus (MRSA)," according to background information in the article. Sporadic outbreaks of linezolid- of MRSA have been reported. Acute bacterial skin and skin structure infections (ABSSSIs) can be life-threatening and may require surgery and hospitalization. "Increasingly, ABSSSIs are associated with drug-, and many have adverse effects restricting their use. Tedizolid is a novel oxazolidinone in development for the treatment of ABSSSIs."

Philippe Prokocimer, M.D., of Trius Therapeutics Inc., San Diego, and colleagues conducted a study to establish the noninferiority of tedizolid phosphate vs. linezolid in treating ABSSSIs and compare the safety of the 2 agents. The phase 3, randomized trial was conducted from August 2010 through September 2011 at 81 study centers in North America, Latin America, and Europe. The intent-to-treat analysis set consisted of data from 667 adults ages 18 years or older with ABSSSIs treated with tedizolid phosphate (n = 332) or linezolid (n = 335). Patients were randomized to a 200 mg once daily dose of oral tedizolid phosphate for 6 days or 600 mg of oral linezolid every 12 hours for 10 days. The primary efficacy outcome was early clinical response at the 48- to 72-hour assessment (no increase in lesion surface area from baseline and oral temperature of 99.7°F or less, confirmed by a second temperature measurement within 24 hours). A 10 percent noninferiority margin was predefined.

The researchers found in the primary efficacy intent-to-treat (ITT) analysis, the response rates at the 48- to 72-hour assessment were 79.5 percent of 332 patients in the tedizolid phosphate group and 79.4 percent of 335 patients in the linezolid group. Sustained clinical treatment response rates at the end of treatment (day 11) were similar in the tedizolid phosphate and linezolid groups in the ITT analysis set (69.3 percent vs. 71.9 percent, respectively). Investigator-assessed clinical treatment response at the post-therapy evaluation (PTE) visit was also similar in the tedizolid phosphate and linezolid groups in the ITT analysis set (85.5 percent vs. 86.0 percent, respectively).

"Of particular interest are the similar treatment response rates in the tedizolid phosphate group (78.0 percent) and in the linezolid group (76.1 percent) in the sensitivity analysis that was based on the Foundation for the National Institutes of Health recommended outcome (≥ 20 percent decrease in lesion area)," the authors write.

Also, the researchers found that the rate at the PTE (7 to 14 days after completing therapy) was high (85 percent) for 178 patients infected with MRSA and similar in both the tedizolid phosphate and linezolid treatment groups.

Treatment-emergent adverse events (mostly mild or moderate) occurred in 40.8 percent of patients in the tedizolid phosphate group and 43.3 percent of patients in the linezolid group. The overall incidence of serious adverse events was low and similar between groups.

"A short course of tedizolid phosphate was statistically noninferior to a 10-day course of linezolid for both early and sustained clinical responses in patients with ABSSSIs. Results were consistent for primary and sensitivity analyses, using either objective criteria or investigators' assessments, and treatment response rates were concordant for early and late time points," the authors conclude.

Explore further: Antibiotic linezolid an effective option for treating patients with MRSA infection

More information: JAMA 2013;309(6):559-569

Related Stories

Antibiotic linezolid an effective option for treating patients with MRSA infection

May 16, 2011
The antibiotic linezolid may be more effective than vancomycin in treating ventilated patients who develop methicillin-resistant Staphylococcus aureus (MRSA) pneumonia as a result of their ventilation, according to a study ...

Antibiotic shows promise in treating extensively drug-resistant tuberculosis

October 18, 2012
When tested in patients hospitalized with extensively drug-resistant tuberculosis (XDR-TB) unresponsive to previous treatment, linezolid, an antibiotic used to treat severe bacterial infections, proved largely effective when ...

Study: Optimal treatment duration for MRSA-related pneumonia

October 19, 2012
The national practice guideline for treating MRSA-related pneumonia is seven to 21 days. A Henry Ford Hospital study found that effective treatment can be done in half the time.

Study evaluates antibiotic option for treating bladder infection in women

February 7, 2012
Short-term use of the antibiotic cefpodoxime for the treatment of women with uncomplicated cystitis (bladder infection) did not meet criteria for noninferiority for achieving clinical cure compared with ciprofloxacin, a drug ...

Kidney drugs hampered by high blood phosphate

August 18, 2011
High blood phosphate levels can set chronic kidney disease (CKD) patients on a rapid path to kidney failure, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). To ...

Recommended for you

Male hepatitis B patients suffer worse liver ailments, regardless of lifestyle

July 25, 2017
Why men with hepatitis B remain more than twice as likely to develop severe liver disease than women remains a mystery, even after a study led by a recent Drexel University graduate took lifestyle choices and environments ...

Researchers report new system to study chronic hepatitis B

July 25, 2017
Scientists from Princeton University's Department of Molecular Biology have successfully tested a cell-culture system that will allow researchers to perform laboratory-based studies of long-term hepatitis B virus (HBV) infections. ...

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

Research examines lung cell turnover as risk factor and target for treatment of influenza pneumonia

July 24, 2017
Influenza is a recurring global health threat that, according to the World Health Organization, is responsible for as many as 500,000 deaths every year, most due to influenza pneumonia, or viral pneumonia. Infection with ...

Scientists propose novel therapy to lessen risk of obesity-linked disease

July 24, 2017
With obesity related illnesses a global pandemic, researchers propose in the Journal of Clinical Investigation using a blood thinner to target molecular drivers of chronic metabolic inflammation in people eating high-fat ...

Raccoon roundworm—a hidden human parasite?

July 24, 2017
The raccoon that topples your trashcan and pillages your garden may leave more than just a mess. More likely than not, it also contaminates your yard with parasites—most notably, raccoon roundworms (Baylisascaris procyonis).

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.