Questions

Hi Everyone!  Since there have been some eligibility and exclusion questions I wanted to share with you all the questions and answers.

Is a subject with enterococcus eligible?
As per Protocol version 2.1, Section 8.5.3.1.1, these subjects are eligible as long as they have not been previously treated with Levofloxacin. Only coagulase-negative Staphylococcus and non-Group D Streptococci are considered non - pathogenic for cUTI in this study. Further, subjects with only Staphylococcus aureus isolated from the baseline urine culture, must be discontinued from study drug.

What happens to a subject that is found to have a bacterial organizm that is resistant to Levo or CXA201 (confirmed at baseline culture report)?
As per Protocol version 2.1, Section 8.5.6.1, if an organism found to be resistant to 1 or both study drugs is isolated from the urine, the Investigator should use their clinical judgement (primarily based on the individual subject's response to therapy) to determine whether the subject should remain on study drug therapy. See Section 8.5.6.1 for more details

The protocol has been broken out by section for your convience and easy access.  You can find it the Study Library. 

I am so excited to be receiving these questions and encourage them. Do not hesitate to reach out to us for any reason at all~  I look forward to hearing from you!

Submitted by Diana Vergato