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

• Status: Completed
• Trial end date: 2018-04-11
• Target enrollment: 0
• Participant gender: All

Summary

This research is being done to determine if Nitazoxanide (NTZ) will cause a significant decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment. The study is being conducted at the GHESKIO Centers in Port au Prince Haiti

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Ethambutol; Isoniazid; Nitazoxanide; Pyrazinamide; Rifampin

Criteria

Inclusion Criteria:

• Men and women ages 18 - 65

• Diagnosed with pulmonary tuberculosis via: sputum-microscopy smear-positive (2+ or 3+) within 14 days plus Sputum GeneXpert positive within 14 days plus Chest radiograph consistent with M. tuberculosis within 14 days

• TB treatment naïve at time of enrollment

• Bodyweight > 40kg

• Negative HIV test within 30 days

• Able to complete activities of daily living (ADLs)

• All participants must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization)

• All female participants must agree to use barrier methods such as condoms as well as hormonal contraception for dual prophylaxis.

• Able to give informed consent and demonstrate understanding of this study and willingness to participate in this study

• Willing to be hospitalized for 2 weeks

Exclusion Criteria:

• Pregnancy

• Evidence of complications of M. tuberculosis such as hemoptysis or shortness of breath

• Extrapulmonary manifestations of M. tuberculosis

• History of prior active tuberculosis

• Evidence of rifampin resistance via GeneXpert

• Previous diagnosis of diabetes or suggestion of impaired glucose metabolism via random plasma glucose

• Previous diagnosis of HIV by any rapid HIV test or by ELISA

• Any of the following lab abnormalities: Creatinine > 1.5 times the ULN; Random glucose > 2 times the ULN; ALT, AST, or alkaline phosphatase > 2 times the ULN; Hemoglobin < 7.5 g/dL

• Any participant currently taking antimycobacterial therapy or within the past 30 days

• Any concomitant illness that could compromise patient safety in this trial such as renal failure, chronic liver disease or alcoholic dependency

• Enrolled in another clinical trial