Assessing Diagnostics At Point-of-care for Tuberculosis
Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and l
| Condition(s) | Tuberculosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests. |
| Who can participate | Novel TB triage and diagnostic tests: Inclusion Criteria- The investigators will include non-hospitalized adults (age ≥ 12 years) with either: 1. cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups; OR 2. risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below: Positive TB screening definitions by risk factor: 1. People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) \>5 mg/dL OR abnormal chest x-ray (CXR) |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | University of California, San Francisco |
| Locations | Abuja, Nigeria; Dasmariñas, Philippines; Lusaka, Zambia |
| Start date | 2023-08-28 |
| NCT ID | NCT05941052 |
| Official listing | https://clinicaltrials.gov/study/NCT05941052 |