Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission
NCT ID: NCT02355223
Last Updated: 2018-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
11060 participants
INTERVENTIONAL
2016-08-31
2020-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Epidemiology of MDR-TB in Peru
NCT00676754
Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation
NCT02231229
Integrated Discovery and Development of Innovative TB Diagnostics
NCT06624501
Performance Evaluation of TB Breath- and Cough-testing Platforms
NCT03025516
Effectiveness of Active Case Finding of Household Contacts in a Routine Tuberculosis (TB) Control Program
NCT02174380
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FAST Implementation
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.
FAST
See information in arm description
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FAST
See information in arm description
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Nacional Hipólito Unanue
UNKNOWN
Socios En Salud Sucursal, Peru
OTHER
Hospital Nacional Arzobispo Loayza
OTHER
Hospital Nacional Sergio Bernales
UNKNOWN
Brigham and Women's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Edward Anthony Nardell, MD
Associate Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edward Nardell, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Nacional Hipolito Unanue
Lima, , Peru
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014P002396
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.