1. Early Bactericidal Activity Trial of Nitazoxanide for Pulmonary Tuberculosis.
- Author
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Walsh, KF, McAulay, K, Lee, MH, Vilbrun, SC, Mathurin, L, Jean Francois, D, Zimmerman, M, Kaya, F, Zhang, N, Saito, K, Ocheretina, O, Savic, R, Dartois, V, Johnson, WD, Pape, JW, Nathan, C, and Fitzgerald, DW
- Subjects
Orphan Drug ,Tuberculosis ,Lung ,Clinical Research ,Infectious Diseases ,Clinical Trials and Supportive Activities ,HIV/AIDS ,Rare Diseases ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Infection ,Good Health and Well Being ,Adult ,Antitubercular Agents ,Female ,Haiti ,Humans ,Male ,Microbial Sensitivity Tests ,Mycobacterium tuberculosis ,Nitro Compounds ,Sputum ,Thiazoles ,Tuberculosis ,Pulmonary ,Young Adult ,tuberculosis ,nitazoxanide ,bactericidal activity ,Microbiology ,Medical Microbiology ,Pharmacology and Pharmaceutical Sciences - Abstract
This study was conducted in treatment-naive adults with drug-susceptible pulmonary tuberculosis in Port-au-Prince, Haiti, to assess the safety, bactericidal activity, and pharmacokinetics of nitazoxanide (NTZ). This was a prospective phase II clinical trial in 30 adults with pulmonary tuberculosis. Twenty participants received 1 g of NTZ orally twice daily for 14 days. A control group of 10 participants received standard therapy over 14 days. The primary outcome was the change in time to culture positivity (TTP) in an automated liquid culture system. The most common adverse events seen in the NTZ group were gastrointestinal complaints and headache. The mean change in TTP in sputum over 14 days in the NTZ group was 3.2 h ± 22.6 h and was not statistically significant (P = 0.56). The mean change in TTP in the standard therapy group was significantly increased, at 134 h ± 45.2 h (P
- Published
- 2020