NCT02355223

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11,060

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

3.5 years

First QC Date

January 28, 2015

Last Update Submit

January 10, 2018

Conditions

Tuberculosis

Keywords

TuberculosisInfection ControlTransmission

Outcome Measures

Primary Outcomes (1)

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

    Time to diagnosis and Time to effective treatment initiation

    5 years

Secondary Outcomes (3)

  • 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

  • Acceptability of FAST, novel screening strategies, and health care worker testing for latent tuberculosis.

    5 years

Study Arms (1)

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.

Other: FAST

Interventions

FASTOTHER

See information in arm description

FAST Implementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nacional Hipolito Unanue

Lima, Peru

RECRUITING

Related Publications (10)

  • Joshi R, Reingold AL, Menzies D, Pai M. Tuberculosis among health-care workers in low- and middle-income countries: a systematic review. PLoS Med. 2006 Dec;3(12):e494. doi: 10.1371/journal.pmed.0030494.

    PMID: 17194191BACKGROUND

  • Brennen C, Muder RR, Muraca PW. Occult endemic tuberculosis in a chronic care facility. Infect Control Hosp Epidemiol. 1988 Dec;9(12):548-52. doi: 10.1086/645774.

    PMID: 3235808BACKGROUND

  • Kantor HS, Poblete R, Pusateri SL. Nosocomial transmission of tuberculosis from unsuspected disease. Am J Med. 1988 May;84(5):833-8. doi: 10.1016/0002-9343(88)90060-5.

    PMID: 3364442BACKGROUND

  • Moran GJ, McCabe F, Morgan MT, Talan DA. Delayed recognition and infection control for tuberculosis patients in the emergency department. Ann Emerg Med. 1995 Sep;26(3):290-5. doi: 10.1016/s0196-0644(95)70074-9.

    PMID: 7661416BACKGROUND

  • Willingham FF, Schmitz TL, Contreras M, Kalangi SE, Vivar AM, Caviedes L, Schiantarelli E, Neumann PM, Bern C, Gilman RH; Working Group on TB in Peru. Hospital control and multidrug-resistant pulmonary tuberculosis in female patients, Lima, Peru. Emerg Infect Dis. 2001 Jan-Feb;7(1):123-7. doi: 10.3201/eid0701.010117.

    PMID: 11266302BACKGROUND

  • Bonifacio N, Saito M, Gilman RH, Leung F, Cordova Chavez N, Chacaltana Huarcaya J, Vera Quispe C. High risk for tuberculosis in hospital physicians, Peru. Emerg Infect Dis. 2002 Jul;8(7):747-8. doi: 10.3201/eid0807.010506. No abstract available.

    PMID: 12095450BACKGROUND

  • ANDREWS RH, DEVADATTA S, FOX W, RADHAKRISHNA S, RAMAKRISHNAN CV, VELU S. Prevalence of tuberculosis among close family contacts of tuberculous patients in South India, and influence of segregation of the patient on early attack rate. Bull World Health Organ. 1960;23(4-5):463-510.

    PMID: 13683486BACKGROUND

  • Kamat SR, Dawson JJ, Devadatta S, Fox W, Janardhanam B, Radhakrishna S, Ramakrishnan CV, Somasundaram PR, Stott H, Velu S. A controlled study of the influence of segregation of tuberculous patients for one year on the attack rate of tuberculosis in a 5-year period in close family contacts in South India. Bull World Health Organ. 1966;34(4):517-32.

    PMID: 5296379BACKGROUND

  • Rouillon A, Perdrizet S, Parrot R. Transmission of tubercle bacilli: The effects of chemotherapy. Tubercle. 1976 Dec;57(4):275-99. doi: 10.1016/s0041-3879(76)80006-2.

    PMID: 827837BACKGROUND

  • 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.

    PMID: 25189547BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Edward Nardell, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Nardell, MD

CONTACT

enardell@gmail.com

Dylan Tierney, MD

CONTACT

dtierney@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 4, 2015

Study Start

August 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

PE(1)