14 Day Early Bactericidal Activity Study of Nitazoxanide for the Treatment of Tuberculosis

Study Director
Carl Nathan, Jean William Pape
Start Date
2 / 2016
Trial Phase
Phase II
Trial Status
all patients enrolled
Current Enrollment
30 April 10, 2018
Target Enrollment

This is a prospective randomized two-arm 14-day, early bactericidal activity study in treatment-naive, drug-susceptible patients with uncomplicated pulmonary tuberculosis (TB). The study is being conducted at the GHESKIO Centers in Port au Prince Haiti. Twenty patients will be randomized to receive NTZ 1 gram orally twice daily for 14 days. Ten patients will be randomized as positive controls to receive standard 4 drug tuberculosis therapy with isoniazid (H), rifampin (R), ethambutol (E), and pyrazinamide (PZA). Patients' sputum is collected before and then every two days during 14 days of treatment, and the primary endpoint is the change in the number of M. tuberculosis in patients' sputum. The primary hypothesis is that NTZ will result in a significant decrease in the number of M. tuberculosis in sputum during14 days of treatment. The number of M. tuberculosis will be quantified by the time to positive (TTP) signal in hours in an automated liquid media culture system (BACTEC MGIT 960, Becton Dickinson).

Compound Associations