Clinical trial NCT02355223: Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission
Official title: Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Keywords: Tuberculosis
Infection Control
Transmission
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Nacional Hipólito Unanue
name: Socios En Salud Sucursal, Peru
name: Hospital Nacional Arzobispo Loayza
name: Hospital Nacional Sergio Bernales
First posted: 2015-02-04
Enrollment: 11060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of time to TB diagnosis and treatment for patients and TB infection rates in health care workers.
timeFrame: 5 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
measure: Costs and cost-effectiveness of FAST
timeFrame: 5 years
measure: Acceptability of FAST, novel screening strategies, and health care worker testing for latent tuberculosis.
timeFrame: 5 years
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Hospital Nacional Hipolito Unanue
Study officials:
affiliation: Brigham and Women's Hospital
name: Edward Nardell, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Dharmadhikari AS, Mphahlele M, Venter K, Stoltz A, Mathebula R, Masotla T, van der Walt M, Pagano M, Jensen P, Nardell E. Rapid impact of effective treatment on transmission of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2014 Sep;18(9):1019-25. doi: 10.5588/ijtld.13.0834.