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Clinical Trials/NCT02355223
NCT02355223UnknownNot Applicable

Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission

Brigham and Women's Hospital1 site in 1 country11,060 target enrollmentStarted: August 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
11,060
Locations
1
Primary Endpoint
Reduction of time to TB diagnosis and treatment for patients and TB infection rates in health care workers.

Study Overview

Brief Summary

The study is designed to evaluate the clinical impact of a novel strategy for tuberculosis (TB) infection control known as FAST (Find cases Actively based on cough surveillance, Separate temporarily, and Treat effectively). It is anticipated that this will decrease time to effective treatment initiation and also decrease transmission of TB to health care workers.

Detailed Description

There is longstanding evidence that tuberculosis (TB) transmission is not from TB patients on effective treatment, but from unsuspected cases, and cases with unsuspected drug resistance. This study seeks to investigate the implementation of a refocused TB transmission control approach that we call FAST (Find cases Actively based on cough surveillance, Separate temporarily, and Treat effectively based on molecular drug-susceptibility testing [DST]). We will conduct this study at Hospital Nacional Hipólito Unanue in Lima, Peru. Our hypothesis is that FAST will reduce delays in identifying infectious TB patients (and unsuspected drug resistance) entering the hospital, facilitate timely effective therapy, and thereby reduce the risk of TB transmission in a cost-effective manner. We will assess the impact of FAST on TB transmission by evaluating IGRA conversions among health care workers at the intervention site, Hospital Nacional Hipolito Unanue (HNHU), and two control sites, Hosptial Nacional Arzobispo Loayza (HNAL) and Hospital Nacional Sergio Bernales (HNSB). We will also evaluate acceptability and barriers to/facilitators of FAST, novel screening strategies, and health care worker IGRA testing using a mixed methods approach.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

FAST Implementation

Other

This single center study will consist of introducing a TB screening program called FAST (Find cases Actively, Separate safely, and Treat Effectively) within the hospital among patients presenting for care who have cough or TB risk factors, and testing them for tuberculosis using a combination of rapid screening and diagnostics tools. The study will evaluate the process of implementation as well as the impact on reducing tuberculosis transmission to health care workers over successive years.

Intervention: FAST (Other)

Outcomes

Primary Outcomes

Reduction of time to TB diagnosis and treatment for patients and TB infection rates in health care workers.

Time Frame: 5 years

Time to diagnosis and Time to effective treatment initiation

Secondary Outcomes

  • Acceptability of FAST, novel screening strategies, and health care worker testing for latent tuberculosis.(5 years)
  • Sensitivity and specificity of a novel exhaled breath test (EBT) and digital chest X-ray with computer assisted detection (dCXR/CAD4TB) as "rule-out" screening tests for tuberculosis in coughing patients(5 years)
  • Costs and cost-effectiveness of FAST(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Edward Anthony Nardell, MD

Associate Physician

Brigham and Women's Hospital

Study Sites (1)

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