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TuberculosisFASTNCT02355223

Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission

A study testing FAST in people with Tuberculosis, run by Brigham and Women's Hospital at 1 site in Peru.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tuberculosis
What is being tested?
FAST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11,060 participants
Where
1 sitePeru
Study dates
Aug 2016to Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Edward Nardell, MD contact

enardell@gmail.com

Dylan Tierney, MD contact

dtierney@partners.org

Peru1 site, 1 recruiting

  • Hospital Nacional Hipolito Unanue

    Lima

    Leo Llecca, MD, llecca_ses@pih.org

    Segundo Leon, sleon_ses@pih.org

    Recruiting

Other trials in Peru

About this study

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.

Read the 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.

Conditions
Tuberculosis
Being tested
FAST
Keywords
Tuberculosis, Infection Control, Transmission
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FASTOther

    See information in arm description

Study groups in NCT02355223
Study groupRoleWhat they receive
FAST ImplementationOtherThis 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.
Receives: Other: FAST

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 5 years

Secondary outcomes (3)

  1. 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

    Sensitivity and specificity of EBT and dCXR/CAD4TB will be calculated along with negative predictive value

    Measured: 5 years

  2. Costs and cost-effectiveness of FAST

    Cost effectiveness analysis

    Measured: 5 years

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

    Qualitative data collection using surveys and focus groups to assess acceptability and barriers

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2015 (estimated)
  2. Study startAug 2016
  3. Primary completionFeb 2020 (estimated)
  4. Study completionFeb 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11,060 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02355223
Sponsor's protocol ID
2014P002396
Acronym
FAST
Status last verified
Jan 2018
First submitted
28 Jan 2015
Last updated
12 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17194191

  • 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.

    PubMed 3235808

  • 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.

    PubMed 3364442

  • 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.

    PubMed 7661416

  • 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.

    PubMed 11266302

  • 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.

    PubMed 12095450

  • 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.

    PubMed 13683486

  • 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.

    PubMed 5296379

  • 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.

    PubMed 827837

  • 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.

    PubMed 25189547

Questions about this trial

What is this clinical trial studying?

A study testing FAST in people with Tuberculosis, run by Brigham and Women's Hospital at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Edward Nardell, MD (enardell@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of time to TB diagnosis and treatment for patients and TB infection rates in health care workers. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02355223, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.

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FAST Clinical Trial NCT02355223 | AzTrials