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| Name | Class |
|---|---|
| Hospital Nacional Hipólito Unanue | UNKNOWN |
| Socios En Salud Sucursal, Peru | OTHER |
| Hospital Nacional Arzobispo Loayza | OTHER |
| Hospital Nacional Sergio Bernales |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAST | Other | See information in arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | Sensitivity and specificity of EBT and dCXR/CAD4TB will be calculated along with negative predictive value | 5 years |
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Inclusion Criteria (for patients):
Exclusion Criteria (for patients):
Inclusion Criteria (for health care workers):
Exclusion Criteria (for health care workers):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward Nardell, MD | Contact | enardell@gmail.com | ||
| Dylan Tierney, MD | Contact | dtierney@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Edward Nardell, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional Hipolito Unanue | Recruiting | Lima | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17194191 | Background | 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. | |
| 3235808 | Background | 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. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| UNKNOWN |
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| Costs and cost-effectiveness of FAST |
Cost effectiveness analysis |
| 5 years |
| 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 |
| 3364442 | Background | 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. |
| 7661416 | Background | 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. |
| 11266302 | Background | 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. |
| 12095450 | Background | 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. |
| 13683486 | Background | 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. |
| 5296379 | Background | 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. |
| 827837 | Background | 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. |
| 25189547 | Background | 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. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |