Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
None listed
Sponsors
Foundation for Innovative New Diagnostics
Eligibility
Inclusion criteria
Inclusion criteria: Aged 18 years or more Clinical suspicion of pulmonary TB including cough >=2 weeks and any other symptom typical of pulmonary TB listed below Fever Malaise Recent weight loss Night sweats Contact with active case Haemoptysis Chest pain Loss of appetite
Exclusion criteria
Exclusion criteria: Unwilling or unable to provide informed consent Unwilling to provide two sputum specimens at enrolment Patients with only extra-pulmonary TB signs & symptoms Receipt of any dose of TB treatment within 6 months prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy for MTB detection: clinical sensitivity and specificity by smear-status measured against mycobacterial culture as the reference standard. Diagnostic accuracy for RIF/INH detection: clinical point estimates of sensitivity and specificity measured against a composite reference standard of phenotypic DST and targeted sequencing Timepoint: seven days | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy for MTB detection: clinical point estimates of sensitivity and specificity measured against mycobacterial culture as the reference standard by subgroup. Operational characteristics: description of operator experience with the assays through daily observed usage anduser appraisal questionnaires Timepoint: 42 days | — |
Countries
Germany, India, Republic of Moldova, South Africa
Contacts
Public ContactDr Jyotirmayee Turuk
ICMR Regional Medical Research Centre, Bhubaneswar
Outcome results
None listed