Tuberculosis
Conditions
Interventions
This is a non-randomized controlled study, with two parallel groups. Intervention group: 120 people diagnosed with drug-resistant tuberculosis and their doctors will receive a whole genome sequencing
E05.393.760.700.825
Sponsors
Instituto de Ciências Biomédicas da Universidade de São Paulo - ICB/USP
Instituto de Ciências Biomédicas da Universidade de São Paulo - ICB/USP
Eligibility
Inclusion criteria
Inclusion criteria: Both sexes. Be a patient of at least one of the six medical centers participating in this study during the data collection period. Patients with treatment failure or relapse in whom antimicrobial resistance is suspected, but diagnostic resistance tests have not been performed or who have a negative result for rifampicin resistance on the Xpert® MTB/RIF Ultra. Patients with a positive test for rifampicin resistance by Xpert® MTB/RIF Ultra. Patients with a negative test for resistance to rifampicin by the Xpert® MTB/RIF Ultra, but positive for resistance to any of the first-line drugs by the Hain ribbon genotypic tests (GenoType MTBDR). Patients with relapse and previous diagnosis of resistant Tuberculosis
Exclusion criteria
Exclusion criteria: Extrapulmonary tuberculosis at the time of diagnosis or diagnosed during the study. Negative culture. Co-infection with nontuberculous mycobacteria. Patients who change treatment centers during the study. Patients who wish to abandon the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe a higher proportion of individuals cured of resistant tuberculosis, according to information from the medical records, in the intervention group than in the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe a lower proportion of individuals dying from resistant tuberculosis, according to information from the medical records, in the intervention group than in the control group.;It is expected to observe a lower proportion of individuals dying from any cause, according to information from the medical record, in the intervention group than in the control group.;It is expected to observe a lower proportion of individuals who changed treatment due to adverse events in the intervention group, according to information in the medical record, than in the control group.;It is expected to observe a lower proportion of individuals who changed treatment due to antimicrobial failure/resistance in the intervention group, according to information in the medical record, than in the control group.;It is expected to observe a lower proportion of individuals with relapse in the intervention group, according to information in the medical record, than in the control group.;It is expected to observe a lower proportion of treatment abandonment in the intervention group, according to information in the medical record, than in the control group;It is expected to observe a higher proportion of completed treatments in the intervention group, according to information in the medical record, than in the control group.;It is expected to see some changes in treatments in the intervention group based on the results of the SGC;It is expected to observe a faster negative conversion of sputum culture in the intervention group, according to information in the medical record, than in the control group.;It is expected to observe a shorter time between the diagnosis of drug-resistant tuberculosis and the start of treatment in the intervention group, according to information in the medical record, than in the control group;It is expected that the intervention group will be treated for a shorter time with ineffective drugs, according to information in the medical record, than the contr | — |
Countries
Brazil
Contacts
Public ContactAna Guimarães
Universidade de São Paulo
Outcome results
None listed