Within 53 anti-infective trials, most of the trials (42, 77.8% of all anti-infective trials) used an NI margin of percentage difference between 10 to 20%.
In recent years, there have been at least 20 different peptides in several steps of development scheduled for anti-infective trials [ 23].
We observed in anti-infective drug trials, that most of them used a constant difference of 10 20% in treatment difference as their NI margin.
Although infections are a major concern in patients with primary systemic vasculitis, actual knowledge about risk factors and evidence concerning the use of anti-infective prophylaxis from clinical trials are scarce.
AHA: American Heart Association IEE, infective endocarditis; RCT, randomized control trial.
Since there are guidelines on the NI margin for anti-infective drugs, we assessed within these trials whether their NI margin was consistent with them.
Over the past 10 years, Dr. Benjamin's group has enrolled more premature infants, at more sites, in more clinical trials of off-patent anti-infectives under an IND than all other academic medical centers, pharmaceutical companies, and government agencies in the world, combined.
Proof-of-concept for the application of AMPs as novel anti-infectives has already been provided in clinical trials.
In the field of anti-infectives, the doses and regimens selected in clinical trials are increasingly informed by dose fractionation studies in animals (9, 10).
Granulomas are a hallmark and focus of infective and immunological processes during infection with Mycobacterium tuberculosis.
At the moment, clinical trials of vitamin D as an anti-infective agent have not demonstrated efficacy.
