CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,332 enrolled
Drug / intervention
PredicTB scoreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05122624
NCT05122624N/ACompleted

PredicTB: Validating a Clinical Risk Score for Early Management of Tuberculosis in Ugandan Primary Health Clinics

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Nov 17, 2021·Updated Jul 23, 2024

In Brief

A clinical study evaluating PredicTB score for Tuberculosis, Pulmonary. Completed, enrolled 3,332 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUganda

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 17, 2021
Enrollment StartNov 10, 2021
Primary CompletionJul 15, 2023
Study CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.6 years ago

Interventions

PredicTB scoreother

This is an easy-to-use clinical risk score designed to improve early management of tuberculosis in highly resource-constrained settings where same-day microbiological testing is unavailable. It consists of readily accessible demographic and clinical data and is scored from 1-10. We will train clinic staff in eight clinics (four study clinics and four comparison clinics) on the Ugandan standard of care for the diagnosis and treatment of TB. In addition, in the four study clinics, we will provide training on the PredicTB score.