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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02684240
• Date of registration: 02/02/2016
• Prospective Registration: No
• Primary sponsor: Weill Medical College of Cornell University
• Public title: A 14 Day Early Bactericidal Activity Study of Nitazoxanide for the Treatment of Tuberculosis
• Scientific title: A 14 Day Early Bactericidal Activity Study of Nitazoxanide for the Treatment of Tuberculosis
• Date of first enrolment: February 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02684240
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Haiti

Contacts

• Name: Daniel W Fitzgerald, MD
• Affiliation: Weill Medical College of Cornell University

• Name: Carl Nathan, MD
• Affiliation: Weill Medical College of Cornell University

• Name: Jean William Pape, MD
• Affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Drug: Nitazoxanide

Other: Control

Primary Outcome(s)

time to positivity (TTP) [Time Frame: first 14 days of anti-tuberculosis therapy]

Secondary Outcome(s)

Maximum plasma concentration of NTZ [Time Frame: first 14 days of anti-tuberculosis therapy]

Most probable number of M tuberculosis in 1 ml of sputum [Time Frame: first 14 days of anti-tuberculosis therapy]

Area under the curve of NTZ metabolites [Time Frame: first 14 days of anti-tuberculosis therapy]

First-line drug susceptibility (DST) of Mycobacterium tuberculosis via Mycobacterial Growth Indicator System (MGIT) [Time Frame: first 14 days of anti-tuberculosis therapy]

Number of participants with treatment-related adverse events as determined by DAIDS toxicity tables [Time Frame: first 14 days of anti-tuberculosis therapy]

Quantification of change in urine metabolites and correlation with change in TTP [Time Frame: first 14 days of anti-tuberculosis therapy]

Change in Minimum inhibitory concentration (MIC) of NTZ against Tuberculosis over 14 days [Time Frame: first 14 days of anti-tuberculosis therapy]

Minimum plasma concentration of NTZ [Time Frame: first 14 days of anti-tuberculosis therapy]

Change in phylogeny of bacteria determined by sequencing of amplified 16S ribosomal DNA and/or metagenomic sequencing of bacterial DNA [Time Frame: first 14 days of anti-tuberculosis therapy]

Sputum concentration of NTZ [Time Frame: first 14 days of anti-tuberculosis therapy]

Transcriptional signature of treatment response using whole blood transcriptional profiles [Time Frame: first 14 days of anti-tuberculosis therapy]

Secondary ID(s)

1302013616

Source(s) of Monetary Support

Please refer to primary and secondary sponsors