Evaluantion of a new rapid diagnostic test to indetify patients with resistance for tuberculosis´ drugs in Brazil

Not Applicable

• Conditions: Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Special screening examination for respiratory tuberculosis; A00-B99

• Registration Number: RBR-3jpsv2
• Lead Sponsor: Programa Nacional de Controle da Tuberculose CGPNCT / DEVIT Secretaria de Vigilância em Saúde/Ministério da Saúde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Clinical sample from patients with probable drug-resistant pulmonary tuberculosis (TB) according to Brazilian Ministry of Health Standards; Xpert MTB/RIF test positive to sputum sample submitted to LPA-1 test and routine diagnostic procedures (culture and antimicrobial susceptibility test in liquid medium); Sample from patient who has not received treatment regimen for TB sensitive drug or TB-DR/MDR for more than 7 days of the past 30 days; Sample from subject with HIV serological test (positive or negative; if the last documented negative HIV test was performed more than three months before the screening visit, the current serological status should be assessed); Sample from subject aged 18 years or older; Samples from subject with a Karnofsky score of 60 or greater at screening; Subject able to provide their consent by signing in the Informed Consent Form (ICF)

Exclusion Criteria

Samples from patients unwilling to take an HIV test if there is no documented HIV test result within three month; Samples from patients deprived of their liberty; Samples from patients whose Information about whether or not to start anti-TB treatment is not present in the medical records / forms of the participating Health Units or in the notification form; Lung samples with a positive result by Xpert MTB / RIF, in which culture or TS were not performed; Samples from patients with inconclusive results on the LPA1 and /or LPA2 tests; Samples from patients with Mycobacterium tuberculosis (MBT) isolates that do not grow or contaminate in the TS and those identified as non-tuberculous mycobacteria (NTM)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the diagnostic accuracy of the LPA-1 test to detect resistance to rifampicin (RIF) and isoniazid (INH) among individuals submitted to TB-DR or sensitive investigation, using phenotypic drug susceptibility testing (DST).<br>;Compare the diagnostic accuracy of the LPA-1 test with the gold standard, the phenotypic DST, for the detection of RIF resistance.;Assess the diagnostic accuracy of LPA-1 tests in the diagnosis of INH resistance, using phenotypic DST as the gold standard;Assess the diagnostic accuracy of LPA-2 tests in the diagnosis of resistance to capreomycin, amikacin and fluoroquinolones using phenotypic DST as the gold standard

Secondary Outcome Measures

Name	Time	Method
Assess the time elapsed between screening until detection of TB resistant to RIF and TB- MDR, using the result release date in the Laboratory Environment Manager ;Assess the time elapsed between the detection of TB resistant to RIF and MDR-TB, and the begginning of the appropriate treatment;Evaluate the principal difficulties and the facilities to implement a quality system in the participants laboratories, using five indicators to medium and long terms.