A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
This is a single-centre, open-label, single arm, clinical trial in two sequential stages, with no stratification. 12 patients will be enrolled in Stage 1, and a further 12 patients will be enrolled in Stage 2 (total of 24 patients in the trial).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Nitric Oxide agent
isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
TASK Clinical Research Centre
Cape Town, Bellville, South Africa
RECRUITINGSafety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death
Time frame: Dosing period 14 days + Follow-up period 14 days
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