Nitazoxanide Antimicrobial Study

Information:

Type of Study Laboratory Research Study
Design Cohort
Project Site CWRU, Cleveland, Ohio
Sample Size 10-20 Subjects
Population Adults with no history of Tuberculosis disease or evidence of BCG scar
Study Period 2013

Goal of Study:

Treatment of tuberculosis is difficult, requiring long treatment regimens with multiple antibiotics.  Due to the prolonged treatment regimen with sometimes toxic regimens (making medication adherence difficult) and to mycobacterium tuberculosis’ ability to develop resistance, multidrug resistant tuberculosis is becoming more and more prevalent. New more effective, less toxic drugs to treat tuberculosis are urgently needed.  Nitazoxanide is an antibiotic that has been used mostly to treat gastrointestinal infections.  However, recent studies have suggested that nitazoxanide is effective against both replicating and non-replicating mycobacterial bacilli.  It also has a high barrier to resistance and is well tolerated.  In order to further define the effective serum concentrations of nitazoxanide and its main metabolite to kill mycobacterium tuberculosis, this study will use whole blood analysis to determine serum concentrations at which the growth of mycobacterium tuberculosis is prevented.

Objectives of Study:

  1. To determine the in vitro effectiveness of nitazoxanide (and its metabolite tizoxanide) to kill mycobacterium tuberculosis
  2. To determine the serum concentrations at which nitazoxanide and tizoxanide are able to kill mycobacterium tuberculosis
  3. To identify a mechanism of action for killing
  4. To identify the MIC of the drug

 

Published Papers:

Harausz EP, Chervenak KA, Good CE, Jacobs MR, Wallis RS, Sanchez-Felix M, Boom WH, TB Research Unit (TBRU) at Case Western Reserve University. Activity of nitazoxanide and tizoxanide against Mycobacterium tuberculosis in vitro and in whole blood culture.  Tuberculosis (edinb) 2016: 98:92-96. doi 10.1016/j.tube.2016.03.002.  Epub 2016 Mar 22. PMID: 27156623.