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Impact assessment of molecular tests for drug resistant tuberculosis diagnosis in Brazil

Policy Relevant Outcomes from Validating Evidence on Impact of Line Probe Assay and MTB/RIF on Presumptive Diagnosis of DR-TB in Brazil

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-4rprbd
Enrollment
Unknown
Registered
2014-04-02
Start date
2011-10-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant Tuberculosis

Interventions

Three hundred and fifty one ( 351 ) patients suspected of resistant tuberculosis to at least one anti - TB drug, which reach the five ( 5 ) Health Units participants will be subjected to the following
Other

Sponsors

Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro
Lead Sponsor
Centro de Referência Professor Hélio Fraga
Collaborator
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Collaborator
Hospital Sanatório Partenon
Collaborator
Instituto Clemente Ferreira
Collaborator
Instituto Estadual de Doenças do Tórax Ary Parreiras
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Age over 18 years; individuals or their legal representatives who sign the Consent Free and Clear; TB resistant suspected cases defined by the presence of history of previous treatment for TB; patients hospitalized in referral centers for TB at least once in the past 2 years; staying in nursing homes / hostels; homeless population; drug / alcohol abusers; HIV seropositive individuals and contacts of tuberculosis resistant patients positive smear

Exclusion criteria

Exclusion criteria: Pregnant; refusal to participate in any phase of the study; patients with resistant tuberculosis confirmed by culture and with appropriate treatment in progress; patients with tuberculosis results from another laboratory that will used by the physician to initiate anti tuberculosis treatment; extra-pulmonary TB suspected patients (without sputum sample) and permanent patients in police and prisons

Design outcomes

Primary

MeasureTime frame
Evaluate the cost effectiveness of diagnostic tests by analysis of the time interval between the collect of sputum smaear to detect TB cases and the early adoption of appropriate strategy in anti-TB treatment

Secondary

MeasureTime frame
To evaluate the proportion of culture conversion in the 6th. month after to collect of sputum

Countries

Brazil

Contacts

Public ContactAfrânio Kritski

Universidade Federal do Rio de Janeiro

kritskia@gmail.com+55 (21) 2562-2426

Outcome results

None listed

Source: REBEC (via WHO ICTRP)