BACKGROUND
Extensively drug-resistant tuberculosis (XDR-TB) continues to be a serious threat to global public health, due in part to the lack of accurate and efficient diagnostic devices for XDR-TB. A prospective clinical study in an intended-use cohort was designed to evaluate the Akonni Biosystems XDR-TB TruArray® and Lateral Flow Cell (XDR-LFC), which has the potential to address this gap in TB diagnostics.
OBJECTIVE
The objective of this publication is to share documentation of the study conceptualization and design that is replicable and of use to the scientific community.
METHODS
This clinical study was conducted in three phases, the first to observe changes in bacterial load and culture positivity in patient sputa over time and better understand the diversity of prospective clinical samples, the second to prospectively collect clinical samples for sensitivity and specificity testing of the Akonni Biosystems XDR-LFC device, and the third to explore anti-TB drug concentrations in serum over the course of DR-TB treatment.
RESULTS
The methodology described includes the study design, laboratory sample handling, data collection, and human subjects protection elements of the clinical study to evaluate a potential new XDR-TB diagnostic device. The complex systems implemented facilitated thorough clinical data collection for objective evaluation of the device. This trial is closed to recruitment. Follow-up data collection and analysis are in progress.
CONCLUSIONS
This publication outlined the methods used in a prospective cohort study to evaluate a device to rapidly detect XDR-TB. The documentation of this clinical study design may be of use to other researchers with similar goals.
Characteristics analysis for clinical study design relating to COVID-19 based on the database of ClinicalTrials.gov
