Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission

Tuberculosis Clinical Trial

— FAST  

Official title:

Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02355223
• Other study ID #: 2014P002396
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2015
• Last updated: January 10, 2018
• Start date: August 2016
• Est. completion date: February 2020

Study information

• Verified date: January 2018
• Source: Brigham and Women's Hospital
• Contact: Edward Nardell, MD
• Email: enardell[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). It is anticipated that this will decrease time to effective treatment initiation and also decrease transmission of TB to health care workers.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11060
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• FAST
See information in arm description

Locations

Country	Name	City	State
Peru	Hospital Nacional Hipolito Unanue	Lima

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Hospital Nacional Arzobispo Loayza, Hospital Nacional Hipólito Unanue, Hospital Nacional Sergio Bernales, Socios En Salud Sucursal, Peru

Country where clinical trial is conducted

Peru, 

References & Publications (10)

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;23:463-510. — View Citation

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. — View Citation

Brennen C, Muder RR, Muraca PW. Occult endemic tuberculosis in a chronic care facility. Infect Control Hosp Epidemiol. 1988 Dec;9(12):548-52. — View 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. — View Citation

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. Review. — View Citation

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. — View Citation

Kantor HS, Poblete R, Pusateri SL. Nosocomial transmission of tuberculosis from unsuspected disease. Am J Med. 1988 May;84(5):833-8. — View Citation

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. — View Citation

Rouillon A, Perdrizet S, Parrot R. Transmission of tubercle bacilli: The effects of chemotherapy. Tubercle. 1976 Dec;57(4):275-99. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	5 years
Secondary	Costs and cost-effectiveness of FAST	Cost effectiveness analysis	5 years
Secondary	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	5 years