Towards the end of the project, the goal is to use the data collected from the Phase IIb Randomized Clinical Trial to generate the correspondent set of in silico models, in other words, the virtual patients to represent each individual enrolled in the trial, for a total of 140 profiles, 90 for the drug sensitive cohort and 50 for the multi-drug resistant cohort.
As of early January 2023, the partners from the University of Catania were able to generate the first 90 in silico models corresponding to the 90 enrolled patients for the drug sensitive cohort, by using the immunological parameters and the bacterial load detected through the active phase of the study.
These generated in silico models have been then used as input for the UISS- TB computational modelling framework to predict:
the percentage of patients with sputum culture negative at time frame up to week 2;
the acid-fast bacilli smear grade at time frame of the primary endpoint and at the end of the active phase.
The same process will be applied to to generate the remaining 50 in silico models corresponding to the MDR patients as soon as the data will be provided by the CRO handling the trial.