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CLINICAL SYMPTOMS AND MICROBIOLOGICAL OUTCOMES IN TUBERCULOSIS TREATMENT TRIALS

Bark, Charles
http://rave.ohiolink.edu/etdc/view?acc_num=case1307630776

Abstract Details

2011, Master of Sciences, Case Western Reserve University, Epidemiology and Biostatistics.
During a recent Federal Drug Administration workshop on tuberculosis trials, questions were raised regarding the use of bacteriologic surrogate endpoints. FDA scientists asked if these endpoints reflect changes in patients’ clinical symptoms. We analyzed data from an international TB treatment trial that included 394 subjects. The percentage of subjects with self-reported symptoms at baseline ranged from 30% for dyspnea to 81% for cough. Most symptoms decreased rapidly during therapy with near resolution by the end of therapy. Cough resolved more slowly, and 13% of patients reported cough at six months. Among the 16 subjects with microbiological relapse, symptoms returned with significant increases in the proportion with fever and cough. Cough was most frequent, occurring in 75% of subjects who relapsed but only 12% who did not. Our data support the continued use of bacteriologic endpoints as surrogate measures of the relief of symptoms and favorable clinical outcomes in TB trials.
Alfred Rimm, PhD (Committee Chair)
John Johnson, MD (Committee Member)
O'Brien Ralph, PhD (Committee Member)
30 p.
Medicine
tuberculosis; symptoms; surrogate endpoints

Recommended Citations

Citations

  • Bark, C. (2011). CLINICAL SYMPTOMS AND MICROBIOLOGICAL OUTCOMES IN TUBERCULOSIS TREATMENT TRIALS [Master's thesis, Case Western Reserve University]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=case1307630776

    APA Style (7th edition)

  • Bark, Charles. CLINICAL SYMPTOMS AND MICROBIOLOGICAL OUTCOMES IN TUBERCULOSIS TREATMENT TRIALS. 2011. Case Western Reserve University, Master's thesis. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=case1307630776.

    MLA Style (8th edition)

  • Bark, Charles. "CLINICAL SYMPTOMS AND MICROBIOLOGICAL OUTCOMES IN TUBERCULOSIS TREATMENT TRIALS." Master's thesis, Case Western Reserve University, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=case1307630776

    Chicago Manual of Style (17th edition)

case1307630776
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© 2011, all rights reserved.
This open access ETD is published by Case Western Reserve University School of Graduate Studies and OhioLINK.