title: Mortality in a large tuberculosis treatment trial: modifiable and non-modifiable risk factors.
abstract: METHODS
  North America.
  
  
  OBJECTIVE
  Tuberculosis (TB) patients in North America often have characteristics that may increase overall mortality. Identifying modifiable risk factors would allow for improvements in outcome.
  
  
  METHODS
  We evaluated mortality in a large TB treatment trial conducted in the United States and Canada. Persons with culture-positive pulmonary TB were enrolled after 2 months of treatment, treated for 4 more months under direct observation, and followed for 2 years (total observation: 28 months). Cause of death was determined by death certificate, autopsy, and/or clinical observation.
  
  
  RESULTS
  Of 1075 participants, 71 (6.6%) died: 15/71 (21.1%) HIV-infected persons, and 56/1004 (5.6%) non-HIV-infected persons (P < 0.001). Only one death was attributed to TB. Cox multivariate regression analysis identified four independent risk factors for death after controlling for age: malignancy (hazard ratio [HR] 5.28, P < 0.0001), HIV (HR 3.89, P < 0.0001), daily alcohol (HR 2.94, P < 0.0001), and being unemployed (HR 1.99, P = 0.01). The risk of death increased with the number of independent risk factors present (P < 0.0001). Extent of disease and treatment failure/relapse were not associated with an increased risk of death.
  
  
  CONCLUSIONS
  Death due to TB was rare. Interventions to treat malignancy, HIV, and alcohol use in TB patients are needed to reduce mortality in this patient population.
authors.affiliation: Division of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee 37232, USA. timothy.sterling@vanderbilt.edu
authors.forename: T R
authors.initials: TR
authors.lastname: Sterling
authors.forename: Z
authors.initials: Z
authors.lastname: Zhao
authors.forename: A
authors.initials: A
authors.lastname: Khan
authors.forename: R E
authors.initials: RE
authors.lastname: Chaisson
authors.forename: N
authors.initials: N
authors.lastname: Schluger
authors.forename: B
authors.initials: B
authors.lastname: Mangura
authors.forename: M
authors.initials: M
authors.lastname: Weiner
authors.forename: A
authors.initials: A
authors.lastname: Vernon
mesh_terms: D000328:Adult; D000569:Americas / Q000453:epidemiology; D000995:Antitubercular Agents / Q000627:therapeutic use; D002170:Canada / Q000453:epidemiology; D002423:Cause of Death; D016009:Chi-Square Distribution; D023801:Directly Observed Therapy; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D016896:Treatment Outcome; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy / Q000401:mortality*
chemical_list: D000995:Antitubercular Agents