Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation.

ABSTRACT:

Background

The APEKS-cUTI study demonstrated the non-inferiority of cefiderocol to imipenem-cilastatin in the primary endpoint of the composite of clinical and microbiological outcome in patients with complicated urinary tract infections (cUTIs). We piloted a structured patient interview (SPI) to evaluate clinical outcomes based on patient-reported symptoms while conducting this pivotal randomized, double-blind, phase-2 study. The objectives were to assess the value of the SPI, using its performance relative to physician assessment, and also to strengthen the value of patient-reported measures in conducting clinical trials for cUTI treatment.

Methods

In addition to the protocol-defined clinical and microbiological outcomes, patients randomized in the APEKS-cUTI study were in

SUBMITTER: Portsmouth S 

PROVIDER: S-EPMC8637798 | biostudies-literature | 2021 Jan-Dec

REPOSITORIES: biostudies-literature