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A Clinical Risk Score for Early Management of TB in Uganda

NCT05122624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3332

Last updated 2024-07-23

Study results available
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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.

Conditions

  • Tuberculosis, Pulmonary

Interventions

OTHER

PredicTB score

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • David W Dowdy, MD/PHD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2023-07-15
Completion
2024-02-29

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05122624 on ClinicalTrials.gov