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Clinical Question
How effective is omadacycline compared with moxifloxacin for the treatment of community-acquired pneumonia?
Bottom line
This new, very expensive antibiotic is no worse (or better) than an older and cheaper respiratory fluoroquinolone for treating community-acquired pneumonia (CAP). Another trial in the same issue of the journal shows the same result for the treatment of skin and skin structure infections, with omadacycline being noninferior to linezolid. 1b-
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Inpatient (ward only)
Synopsis
Omadacycline is in a new class of antibiotics called aminomethylcyclines, which are related to tetracyclines and have a similar spectrum. In vitro, they are effective against most common causes of CAP, including mycoplasma, legionella, and chlamydia pneumonia. These researchers identified 774 adults with lower respiratory symptoms, abnormal vital signs, and radiographically confirmed pneumonia who were admitted to the hospital (but not the intensive care unit). Based on the Pneumonia Severity Index, most of the patients would be classified as having moderate to severe pneumonia. Their mean age was 62 years, 56% were men, less than 10% were non-white, and only 14% had mild to moderate chronic obstructive pulmonary disease. Patients were randomized, with allocation concealed, to receive either omadacycline 100 mg intravenously (IV) every 12 hours for 2 doses, then 100 mg IV once daily, with the option to switch to 300 mg orally once daily after at least 3 days of IV therapy, or to moxifloxacin 400 mg IV once daily, with the option to switch to 400 mg orally after at least 3 days of IV therapy. The authors sliced and diced the study population into intention-to-treat versus per protocol analyses, and by risk class. In each case, there was no difference in the likelihood of early clinical response or overall clinical response at the end of therapy. The differences in response rates, in addition to not being statistically significant, were also not clinically significant, in the range of 2% to 3% for most outcomes. Serious adverse events were similar between groups, and there were 8 deaths in the omadacycline group and 4 in the moxifloxacin group (nonsignificant).
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA