NCT05122624Completed
A Clinical Risk Score for Early Management of TB in Uganda
PredicTB: Validating a Clinical Risk Score for Early Management of Tuberculosis in Ugandan Primary Health Clinics
Source: ClinicalTrials.gov · Last updated 23 Jul 2024
Brief summary (registry, in English)
Although curative treatment exists, tuberculosis (TB) remains the leading cause of infectious mortality worldwide - often because people seek care for TB symptoms in highly resource-constrained clinics that cannot provide same-day diagnostic testing. The research team has developed an easy-to-use clinical risk score that, if implemented in these settings, might help clinicians identify patients at high risk for TB and thereby start treatment for those patients on the same day. This study will investigate the effectiveness and implementation of this score in four peri-urban clinics in Uganda, providing critical pragmatic data to inform (or halt) the design of a definitive large-scale cluster randomized trial.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 3332 (actual)
- First submitted
- 1 Nov 2021
- Start date
- 10 Nov 2021
- Primary completion date
- 15 Jul 2023
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Diseases
- Tuberculosis
- NCT number
- NCT05122624
What you commit to
- Study type: Interventional
- Participants enrolled: 3332
- From 10 Nov 2021 to the primary completion date, 15 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age \< 15 years old
Who the study is looking for
- All adult patients submitting sputum for a new diagnosis of pulmonary TB in the four study clinics and four comparison clinics between month -6 and month 18 will have their records abstracted by study staff.
- Starting in the 13th month after PredicTB implementation (i.e., after the 12-month post-implementation period has ended), study staff will position themselves in the four study clinics for purposes of recruiting and enrolling adult patients submitting sputum for a new diagnosis of pulmonary TB. No exclusions will be made except for age (as above), and we will seek to enroll all consecutive patients until our target sample size (25 participants per clinic, total n = 100) has been reached.
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Makerere University Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.