FDA Advises on Clinical Trials for Uncomplicated UTI Treatments

The FDA invited comments from stakeholders on a new draft guidance for clinical trial designs and drug development programs to support indications for uncomplicated urinary tract infection (uUTI) treatments.

The clinical trial population consists of female patients with uUTIs with a preapproval safety database of at least 880 patients at the treatment’s proposed dose and duration. The size of the database should be discussed with the agency during clinical development.

Patients showing signs of systemic illness, such as a fever greater than 100.4 Fahrenheit, shaking chills or other clinical manifestations suggestive of uUTI should be excluded, as well as patients being treated with other antibacterial drugs effective in treating uUTI.