Artificial Inteligent for Diagnosing Drug-Resistant Tuberculosis

CompletedOBSERVATIONAL
Enrollment

524

Participants

Timeline

Start Date

June 15, 2020

Primary Completion Date

September 30, 2020

Study Completion Date

October 2, 2020

Conditions
MDR TuberculosisResistance to Tuberculostatic Drugs
Interventions
DIAGNOSTIC_TEST

Rapid Molecular Drug-Resistant Tuberculosis Test

"GeneXpert MTB/RIF assay is a nucleic acid amplification (NAA) test which simultaneously detects DNA of Mycobacterium tuberculosis complex (MTBC) and resistance to rifampin (RIF) (i.e. mutation of the rpoB gene) in less than two hours. This system integrates and automates sample processing, nucleic acid amplification, and detection of the target sequences. The primers in the XpertMTB/RIF assay amplify a portion of the rpoB gene containing the 81 base pair core region. The probes are able to differentiate between the conserved wild-type sequence and mutations in the core region that is associated with rifampicin resistance. The output of this procedure is detected, undetected, or indeterminate."

OTHER

Artificial Intelligent Model

The artificial intelligent model is a model that developed from several associated factors with machine learning and deep learning method in order to classify the possibility of drug-resistant tuberculosis. The Artificial neural network will be built using deep learning software.

DIAGNOSTIC_TEST

Drug Susceptibility Test

This procedure uses Löwenstein-Jensen (LJ) medium to determine whether the isolates of M. tuberculosis are susceptible to anti-TB agents. Media containing the critical concentration of the anti-TB agent is inoculated with a dilution of a culture suspension (usually a 10-2 dilution of a MacFarland 1 suspension) and control media without the anti-TB agent is inoculated with usually a 10-4 dilution of a MacFarland 1 suspension. Growth (i.e. a number of colonies) on the agent-containing media is compared to the growth on the agent-free control media. The ratio of the number of colonies on the medium containing the anti-TB agent to the number of colonies (corrected for the dilution factor) on the medium without the anti-TB agent is calculated, and the proportion is expressed as a percentage. Provisional results for susceptible isolates may be read after 3-4 weeks of incubation; definitive results may be read after 6 weeks of incubation. Resistance may be reported within 3-4 weeks.

Trial Locations (5)

76115

Kanudjoso Djatiwibowo General Hospital, Balikpapan

76124

Wahidin Sudirohusodo General Hospital, Makassar

77113

Tarakan General Hospital, Tarakan

90132

Labuang Baji General Hospital, Makassar

Unknown

Balai Besar Kesehatan Paru Masyarakat, Makassar

All Listed Sponsors
collaborator

Chulalongkorn University

OTHER

lead

Hasanuddin University

OTHER

NCT04208789 - Artificial Inteligent for Diagnosing Drug-Resistant Tuberculosis | Biotech Hunter | Biotech Hunter