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MDR Tuberculosis clinical trials

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NCT ID: NCT04208789 Completed - Clinical trials for Resistance to Tuberculostatic Drugs

Artificial Inteligent for Diagnosing Drug-Resistant Tuberculosis

Start date: June 15, 2020
Phase:
Study type: Observational

Title: Artificial Neural Network as Diagnostic Tools For Rifampicin-Resistant Tuberculosis In Indonesia. A Predictive Model Study and Economic Evaluation. Background: Drug-resistant tuberculosis has become a global threat particularly in Indonesia. The need to increase detection, followed by appropriate treatment is a concern in dealing with these cases. The rapid molecular test (specifically for detecting rifampicin-resistant) is now being utilized in health care service, particularly at primary care level with some challenges including the lack of quality control (including how to obtained and treat the specimen properly prior to the examination) which then, affect the reliability of the results. Drug-Susceptibility Test (DST) is still, the gold standard in diagnosing drug-resistant tuberculosis but this procedure is time-consuming and costly. The artificial intelligent including data exploration and modeling is a promising method to classify potential drug-resistant cases based on the association of several factors. Objective : 1. To develop a model using an artificial intelligence approach that is able to classify the possibility of rifampicin-resistant tuberculosis. 2. To assess the diagnostic ability and the accuracy of the model in comparison to existing rapid test and the gold standard 3. To evaluate the cost-effectiveness evaluation of Artificial Neural Network model in Web-Based Application in comparison with the standard diagnostic tools Methodology 1. A cross-sectional study involving all suspected drug-resistant tuberculosis cases that being referred to the study center to undergo rapid molecular test and DST test over the past 5 years. 2. A comprehensive, retrospective medical records assessment and tuberculosis individual report will be performed to obtain a variable of interest. 3. Questionnaire assessment for confirmation of insufficient information. 4. Model Building through machine learning and deep learning procedure 5. Model Validation and testing using training data set and data from the different study center Hypothesis : Artificial Intelligent Model will yield a similar or superior result of diagnostic ability compare the Rapid Molecular Test according to the Drug-Susceptibility Test. (Superiority Trial)