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Evaluation of a new portable test to help the diagnosis of tuberculosis

Evaluation of a complete technological solution (DNA extraction + qPCR) to help the diagnosis of tuberculosis at the point of care

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-288qb6h
Enrollment
Unknown
Registered
2024-10-10
Start date
2021-04-01
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

Pulmonary Tuberculosis

Interventions

This is an observational study which will collect two samples in a single time point from up to 500 participants suspected of tuberculosis infection. Sputum samples will be collected by the participan
E05.393.620.500.706
E01.370.225.880

Sponsors

Fundação Oswaldo Cruz
Lead Sponsor
Universidade Luterana do Brasil
Collaborator
Escola de Saúde Pública da Secretaria de Saúde do Estado do Rio Grande do Sul
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Be older than 18 years; be symptomatic suspecting of tuberculosis; to participate voluntarely; to produce at least 0.5 mL of sputum; both sexes shall be included

Exclusion criteria

Exclusion criteria: To have been previously infected with micobatérias não tuberculosas; not being able to produce the required sample volume

Design outcomes

Primary

MeasureTime frame
Determination of the sensitivity and specificity of the new diagnostic procedure relative to the standard techniques—

Secondary

MeasureTime frame
Evaluation of total cost effectiveness.;Evaluate the time to obtain the test result after sample collection—

Countries

Brazil

Contacts

Public ContactAlexandre Costa

Fundação Oswaldo Cruz

alexandre.costa@fiocruz.br+55-41-988952026

Outcome results

None listed

Source: REBEC (via WHO ICTRP)