FujiLAM Prospective Evaluation Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1731 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-13

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Computer Aided Screening for Tuberculosis in Low Resource Environments

NCT04545164

Tuberculosis Infection HIV Infections

COMPLETED NA

Feasibility of a Lateral Flow Urine Lipoarabinomannan (LAM) Test for Diagnosis of Tuberculosis

NCT01525134

Tuberculosis Tuberculosis, Pulmonary Tuberculosis, Miliary

UNKNOWN NA

Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients

NCT06709157

Tuberculosis

NOT_YET_RECRUITING

TB-LAM in the Diagnosis of TB

NCT04600232

HIV Infections Tuberculosis Non-Tuberculous Mycobacterial Pneumonia

UNKNOWN NA

Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3

NCT02057796

HIV-1 Infection

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diagnosis of Tuberculosis in People Living With HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fujifilm SILVAMP TB LAM

Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Omega VISITECT® CD4 Advanced Disease test

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No