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Early Bactericidal Activity Trial of Nitazoxanide for Pulmonary Tuberculosis.
- Source :
-
Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2020 Apr 21; Vol. 64 (5). Date of Electronic Publication: 2020 Apr 21 (Print Publication: 2020). - Publication Year :
- 2020
-
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 < 0.0001). The mean NTZ MIC for Mycobacterium tuberculosis isolates was 12.3 μg/ml; the mean NTZ maximum concentration ( C <subscript>max</subscript> ) in plasma was 10.2 μg/ml. Negligible NTZ levels were measured in sputum. At the doses used, NTZ did not show bactericidal activity against M. tuberculosis Plasma concentrations of NTZ were below the MIC, and its negligible accumulation in pulmonary sites may explain the lack of bactericidal activity. (This study has been registered at ClinicalTrials.gov under identifier NCT02684240.).<br /> (Copyright © 2020 American Society for Microbiology.)
- Subjects :
- Adult
Antitubercular Agents adverse effects
Female
Haiti
Humans
Male
Microbial Sensitivity Tests
Nitro Compounds adverse effects
Sputum microbiology
Thiazoles adverse effects
Young Adult
Antitubercular Agents pharmacokinetics
Antitubercular Agents therapeutic use
Mycobacterium tuberculosis drug effects
Nitro Compounds pharmacokinetics
Nitro Compounds therapeutic use
Thiazoles pharmacokinetics
Thiazoles therapeutic use
Tuberculosis, Pulmonary drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1098-6596
- Volume :
- 64
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Antimicrobial agents and chemotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 32071052
- Full Text :
- https://doi.org/10.1128/AAC.01956-19