Our TB Clinical Research Group at Boston University School of Medicine’s Pulmonary Center is engaged in multi-center consortium studies, investigator-initiated local research studies, and educational efforts locally, regionally and nationally.
TB Trials Consortium
Our site has been very active within the Centers for Disease Control’s Tuberculosis Trials Consortium (TBTC), actively enrolling patients in both latent and active TB treatment trials. We have been active in TBTC committees and in meetings:
- John Bernardo, MD
Site Principal Investigator, TBTC Human Studies Research Committee, TBTC Study 28 Protocol Development Team
- Jussi Saukkonen, MD
Site Co-investigator, TBTC Core Sciences Group (current),
Chair, Recruitment and Retention Committee (past)
- Robert Horsburgh, MD
Site Co-investigator, TBTC Executive Advisory Group, Chair, Publications Committee
- Claire Murphy, RN, MSN, NP
Study Coordinator, Training Advisory Group (current), Internal Quality Control Committee (past)
- Denise Curran, RN
Current TBTC trials in which we are enrolling include:
- Study 26: Isoniazid/Rifapentine weekly for 3 months vs. Isoniazid daily for 9 months for treatment of Latent TB Infection.
- Study 26A: Hepatotoxicity and Viral Hepatitis sub-study for Study 26
- Study 26B: Hypersensitivity sub-study for Study 26
- Study 29: Evaluation of a rifapentine-containing regimen for intensive phase treatment of pulmonary Tuberculosis.
The TBTC website at CDC is at: http://www.cdc.gov/nchstp/tb/tbtc/introduction.htm
TB Epidemiologic Studies Consortium
We also are active in CDC’s Tuberculosis Epidemiologic Studies Consortium (TBESC). In partnership with Massachusetts Department of Public Health, Dr Bernardo, who also serves on the Diagnostics Working Group and the Human Subjects Research Group, and Dr Horsburgh, who also serves on the Research Committee, are active within the TBESC infrastructure.
Current TBESC studies in which we are participating include:
- Task Order 8: An analysis of molecular epidemiology of multi-drug resistant M.tuberculosis in the United States
- Task Order 9: Enhanced surveillance to identify missed opportunities for TB prevention in foreign-born populations in US and Canada
- Task Order 12: Assessing the tuberculosis (TB) knowledge, attitudes, beliefs, and practices among private providers serving foreign-born populations at Risk for TB
- Task Order 13: Prospective cohort study of risk factors for acceptance of, adherence to, and toxicity from treatment for LTBI
- Task Order 16: African Refugee Women’s Health Improvement Project
The TBESC website at CDC is at: http://www.cdc.gov/nchstp/tb/TBESC/TOC.htm
Other national projects:
Dr. Bernardo is the President (2006) of this organization, dedicated to control of tuberculosis in the United States.
National TB Nurses Consultant Coalition
Claire Murphy, RN, MSN, NP is Chair of the Education and Research Committees.
American Thoracic Society
Dr. Jussi Saukkonen is the Chair of the Working Group on Hepatotoxicity of Anti-tuberculosis Therapy, which has completed a document for the ATS.
Investigator-initiated local studies
Several studies are on-going; these include
- Predictors of failure to complete isoniazid for treatment for latent TB infection: a survey study of patients.
- Predictors of Active TB Among Asymptomatic Tuberculin Skin Test Positive Individuals with Upper Lobe Fibrosis.
- TB contact investigation: Evaluation, treatment and outcomes in children less than 5 years of age in Massachusetts.
- Provision of TB Services to Boston’s Homeless: Public Health/Private Domain
- Community-based TB prevention in Massachusetts’ Haitian communities
- Saukkonen, J.J.,D. Cohn, F. Gordin, R. Jasmer,J. Jereb, C. Nolan, D. Nunes, C. Peloquin,
S. Shenker, T. Sterling, D.Strader, R. Venkataramanan. Hepatotoxicity of Anti-Tuberculous Therapy. In press.
- Jasmer, R.M.., L. Bozeman, M.D. Cave, J.J. Saukkonen, K.Schwartzman, B. Metchock, W. Burman Genotyping of Mycobacterium tuberculosis to Distinguish Treatment Failure or Relapse from Reinfection. American Journal of Respiratory and Critical Care Medicine 2004 Dec 15;170(12):1360-6.
- Saukkonen, J.J. Rifampin and Pyrazinamide from Clinical Trial to General Practice. Clinical Infectious Diseases. 2004. Aug 15;39(4):566-8.
- R.M. Jasmer, D. C. Snyder, J. J. Saukkonen., P. C. Hopewell, J. Bernardo, M. D. King., L. M. Kawamura M.D., and C. L. Daley . Short-Course Rifampin and Pyrazinamide Compared with Isoniazid for Latent Tuberculosis Infection: A Cost-Effectiveness Analysis Based on a Multicenter Clinical Trial. Clinical Infectious Diseases, 2004. 38: 363-369.
- R. Jasmer, J.J. Saukkonen, H. M. Blumberg, C. L. Daley, J. Bernardo, E. Vittinghoff, M. King, L. M. Kawamura, and P. Hopewell. Short-Course Rifampin and Pyrazinamide Compared with Isoniazid for Latent Tuberculosis Infection: A Multicenter, Prospective, Randomized, Controlled Trial. Annals of Internal Medicine 137:640-647, 2002.
- Saukkonen, J.J., M. Thomas, R. Strieter, M. Burdick, Bazydlo, B., J. Keane, H. Kornfeld. 2002. ?-Chemokines Are Induced by Mycobacterium tuberculosis and Inhibit Its Growth. Infection and Immunity 70(4):1684-93.
- Jones, B., K. Heldwein, T. Means, J. Saukkonen, M. Fenton. Differential roles of toll like receptors in the elicitation of pro-inlfammatory responses by macrophages. Annals of RheumaticDiseases. 60 (Suppl 3): III6-III12
- Lerman SJ, Bernardo J, Daly JS, Husson R. Tuberculosis prevention in college students. J Am Coll Health. 2004 Sep-Oct;53(2):53-8.
- Raffetto JD, Bernardo J, Menzoian JO. Aortobifemoral graft infection with Mycobacterium tuberculosis: treatment with abscess drainage, debridement, and long-term administration of antibiotic agents. J Vasc Surg. 2004 Oct;40(4):826-9.
- Hsu K, Christiansen D, O’Connor D, Bernardo J, Hacker K. Self-assessment of tuberculosis infection risk by urban adolescents. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1227-31.
- Burman W, Breese P, Weis S, Bock N, Bernardo J, Vernon A; Tuberculosis Trials Consortium. The effects of local review on informed consent documents from a multicenter clinical trials consortium. Control Clin Trials. 2003 Jun;24(3):245-55.
- Mazurek GH, LoBue PA, Daley CL, Bernardo J, Lardizabal AA, Iademarco MF.
Detection of Mycobacterium tuberculosis infection by whole-blood interferon-gamma release assay. Clin Infect Dis. 2003 May 1;36(9):1207-8.
- Miller AC, Butler WR, McInnis B, Boutotte J, Etkind S, Sharnprapai S, Bernardo J, Driscoll J, McGarry M, Crawford JT, Nardell E. Clonal relationships in a shelter-associated outbreak of drug-resistant tuberculosis: 1983-1997. Int J Tuberc Lung Dis. 2002 Oct;6(10):872-8.
- Mazurek GH, LoBue PA, Daley CL, Bernardo J, Lardizabal AA, Bishai WR, Iademarco MF, Rothel JS. Comparison of a whole-blood interferon gamma assay with tuberculin skin testing for detecting latent Mycobacterium tuberculosis infection. JAMA. 2001 Oct 10;286(14):1740-7.
- Polesky A, Farber HW, Gottlieb DJ, Park H, Levinson S, O’Connell JJ, McInnis B, Nieves RL, Bernardo J. Rifampin preventive therapy for tuberculosis in Boston’s homeless. Am J Respir Crit Care Med. 1996 Nov;154(5):1473-7.
- Mtei L, Matee M, Herfort O, Bakari M, Horsburgh CR, Waddell R, Cole BF, Vuola JM, Tvaroha S, Kreiswirth B, Pallangyo K, von Reyn CF. High rates of clinical and subclinical tuberculosis among HIV-infected ambulatory subjects in Tanzania.
Clin Infect Dis. 2005 May 15;40(10):1500-7. Epub 2005 Apr 12.
- Horsburgh CR Jr. Priorities for the treatment of latent tuberculosis infection in the United States. N Engl J Med. 2004 May 13;350(20):2060-7.
- Stratford D, Chamblee S, Ellerbrock TV, Johnson RJ, Abbott D, Reyn CF, Horsburgh CR. Integration of a participatory research strategy into a rural health survey.
J Gen Intern Med. 2003 Jul;18(7):586-8.
- Fisk TL, Hon HM, Lennox JL, Fordham von Reyn C, Horsburgh CR Jr.
Detection of latent tuberculosis among HIV-infected patients after initiation of highly active antiretroviral therapy. AIDS. 2003 May 2;17(7):1102-4.
- Benator D, Bhattacharya M, Bozeman L, Burman W, Cantazaro A, Chaisson R, Gordin F, Horsburgh CR, Horton J, Khan A, Lahart C, Metchock B, Pachucki C, Stanton L, Vernon A, Villarino ME, Wang YC, Weiner M, Weis S; Tuberculosis Trials Consortium. Rifapentine and isoniazid once a week versus rifampicin and isoniazid twice a week for treatment of drug-susceptible pulmonary tuberculosis in HIV-negative patients: a randomised clinical trial. Lancet. 2002 Aug 17;360(9332):528-34.
- Vernon A, Burman W, Horsburgh CR. Another step on the path to better TB therapies. Int J Tuberc Lung Dis. 2002 Jan;6(1):1-2.
- von Reyn CF, Horsburgh CR, Olivier KN, Barnes PF, Waddell R, Warren C, Tvaroha S, Jaeger AS, Lein AD, Alexander LN, Weber DJ, Tosteson AN.
Skin test reactions to Mycobacterium tuberculosis purified protein derivative and Mycobacterium avium sensitin among health care workers and medical students in the United States. Int J Tuberc Lung Dis. 2001 Dec;5(12):1122-8.
- Horsburgh CR Jr, Feldman S, Ridzon R; Infectious Diseases Society of America.
Practice guidelines for the treatment of tuberculosis. Clin Infect Dis. 2000 Sep;31(3):633-9. Epub 2000 Oct 4.
- Horsburgh CR Jr. A large, simple trial of a tuberculosis vaccine.
Clin Infect Dis. 2000 Jun;30 Suppl 3:S213-6.
- Horsburgh CR Jr. The global problem of multidrug-resistant tuberculosis: the genie is out of the bottle. JAMA. 2000 May 17;283(19):2575-6.
- Lein AD, von Reyn CF, Ravn P, Horsburgh CR Jr, Alexander LN, Andersen P. Cellular immune responses to ESAT-6 discriminate between patients with pulmonary disease due to Mycobacterium avium complex and those with pulmonary disease due to Mycobacterium tuberculosis. Clin Diagn Lab Immunol. 1999 Jul;6(4):606-9.
- Dobos KM, Quinn FD, Ashford DA, Horsburgh CR, King CH. Emergence of a unique group of necrotizing mycobacterial diseases. Emerg Infect Dis. 1999 May-Jun;5(3):367-78. Review.
- Horsburgh CR Jr. What it takes to control tuberculosis. Am J Public Health. 1998 Jul;88(7):1015-6.