Diagnosis of Tuberculosis in People Living With HIV Clinical Trial
Official title:
Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM (FujiLAM) Test for the Diagnosis of Tuberculosis in People Living With HIV
| Verified date | January 2022 |
| Source | Foundation for Innovative New Diagnostics, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).
| Status | Completed |
| Enrollment | 1731 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Adult PLHIV (=18 years), irrespective of their CD4 count and antiretroviral therapy (ART) status, at risk of having pulmonary and/or extra-pulmonary TB - Inpatients: irrespective of TB symptoms - Outpatients: at least one of the symptoms suggestive of TB (as defined by WHO*) - written informed consent - willingness to have a trial follow-up visit at 2-3 and 6 months after enrolment (e.g. not planning to relocate) Exclusion Criteria: - Current anti-TB treatment * - Any anti-TB treatment within 60 days prior to enrolment - Any isoniazid preventive therapy within 6 months prior to enrolment * Patients starting anti-TB treatment at the time of enrolment will not be excluded from the trial provided that all trial specimens are collected before starting the 3rd dose of treatment. |
| Country | Name | City | State |
|---|---|---|---|
| Malawi | Malawi-Liverpool-Wellcome Trust Clinical Research Programme | Blantyre | |
| South Africa | CIDRI-Africa University of Cape Town | Cape Town | |
| Tanzania | Ifakara Health Institute | Dar es Salaam | |
| Thailand | The HIV Netherlands Australia Thailand Research collaboration | Bangkok | Bankok |
| Uganda | Infectious Diseases Institute | Kampala | |
| Vietnam | Viet Tiep Hospital | H?i Phòng | Le Chan |
| Zambia | Centre for Infectious Disease Research in Zambia | Lusaka |
| Lead Sponsor | Collaborator |
|---|---|
| Foundation for Innovative New Diagnostics, Switzerland | Centre for Infectious Disease Research in Zambia, Fujifilm, Ifakara Health Institute, Infectious Diseases Institute, Uganda, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, National Tuberculosis Control Programme, Omega Diagnostics, Swiss Tropical & Public Health Institute, The HIV Netherlands Australia Thailand Research Collaboration, Tuberculosis and Lung Disease Hospital in Hai Phong, University of Cape Town, Viet-Tiep Hospital |
Malawi, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS. | Day 1 | ||
| Primary | Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS. | Day 1 | ||
| Primary | Diagnostic yield, with 95% confidence interval, of FujiLAM test among eMRS positive patients and AlereLAM, Smear and Ultra (sputum, urine) as comparators (on Day 1 specimens). | Day 1 |