Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission (FAST)

January 10, 2018 updated by: Edward Anthony Nardell, MD, Brigham and Women's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

11060

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (for patients):

  • adult (≥ 18 years) patients who are receiving care in the emergency department or being admitted for inpatient care from any other hospital area
  • patient presenting with cough or TB risk factors of prior or current TB diagnosis and/or contact of an individual with TB
  • able to participate by providing a sputum sample and/or exhaled breath test sample

Exclusion Criteria (for patients):

  • no specific exclusion criteria at initial screening if the patient meets the above inclusion criteria.

Inclusion Criteria (for health care workers):

  • being an employee or intern at Hospital Nacional Hipolito Unanue (HNHU), Hospital Nacional Arzobispo Loayza (HNAL) or Hospital Nacional Sergio Bernales (HNSB) and deemed to be at risk of exposure to tuberculosis based on line of work
  • age ≥ 18 years
  • willing and able to provide informed consent for participation

Exclusion Criteria (for health care workers):

  • no specific exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FAST Implementation
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.
Other: FAST
See information in arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 5 years
Sensitivity and specificity of EBT and dCXR/CAD4TB will be calculated along with negative predictive value
5 years
Costs and cost-effectiveness of FAST
Time Frame: 5 years
Cost effectiveness analysis
5 years
Acceptability of FAST, novel screening strategies, and health care worker testing for latent tuberculosis.
Time Frame: 5 years
Qualitative data collection using surveys and focus groups to assess acceptability and barriers
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Socios En Salud Sucursal, Peru
Hospital Nacional Arzobispo Loayza
Hospital Nacional Hipólito Unanue
Hospital Nacional Sergio Bernales

Investigators

  • Principal Investigator: Edward Nardell, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P002396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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