Introduction: The production and release of new antibiotics is rare and should be celebrated by clinicians. As antibiotic resistance continues to mount, our options narrow and, in turn, our patients suffer. Recently, the NEJM published two articles on a new antibiotic that was recently FDA approved - omadacycline. The articles compared omadacycline to moxifloxacin in the treatment of community acquired pneumonia (CAP) and to linezolid in the treatment of skin and soft tissue infections. Both studies yielded promising results for the new drug which should be cause of excitement. However, significant biases, methodological flaws and poor selection of comparator treatments should temper our excitement.
Both studies tested the new antibiotic in a non-inferiority set up. Non-inferiority studies seem to be increasingly prevalent in the literature and because they serve an important purpose, it’s important for us to understand them and also to understand why this approach is used and why it may not be appropriate....Read More