Tuberculosis Clinical Trial
Official title:
TBTC Study 28: Evaluation of a Moxifloxacin-based, Isoniazid-sparing Regimen for Tuberculosis Treatment
This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.
The primary objective of this Phase 2 clinical trial is to compare the safety and
antimicrobial activity of a moxifloxacin-containing regimen (moxifloxacin, rifampin,
pyrazinamide, ethambutol [MRZE]) in which moxifloxacin has been substituted for isoniazid,
to the standard control regimen (isoniazid, rifampin, pyrazinamide, ethambutol [HRZE]) in
the first two months of treatment of sputum smear-positive pulmonary tuberculosis. The
assessment of antimicrobial activity will be sputum culture-conversion. Higher rates of
sputum culture conversion after 2 months of treatment with a moxifloxacin-containing regimen
would support Phase 3 clinical trials of moxifloxacin in treatment regimens of less than the
current 6 month standard regimens.
Rationale - Current treatment of smear positive pulmonary tuberculosis requires a minimum of
6 months, a treatment duration that is challenging for patients and tuberculosis control
programs. Therefore, a high priority in tuberculosis research is the identification of
agents that can shorten treatment. Several fluoroquinolone antibiotics have potent activity
against Mycobacterium tuberculosis (M. tuberculosis) in preclinical testing. Of the
currently available fluoroquinolones, moxifloxacin has excellent activity in vitro and in
animal models of tuberculosis, a favorable pharmacokinetic profile (serum half-life of 10-12
hours), lack of problematic drug-drug interactions, no need for dosage adjustment for renal
and hepatic insufficiency, and an excellent safety profile. In addition, in the murine model
of tuberculosis, the substitution of moxifloxacin for isoniazid resulted in significant
reductions in the time to culture conversion and the time to sterilization when compared to
the standard combination rifampin, isoniazid and pyrazinamide. However, moxifloxacin has not
been fully evaluated in humans for tuberculosis treatment. There is a need to assess not
only the anti-tuberculosis activity of moxifloxacin-containing regimens, but also the safety
of more prolonged therapy with moxifloxacin.
Two-month culture conversion rates are a well-accepted surrogate marker for the sterilizing
activity of anti-tuberculosis drugs. Rifampin and pyrazinamide, the key drugs in current
6-month regimens, markedly increase 2-month culture-conversion rates. Therefore, this study
will use 2-month culture conversion rate as the measure of antimicrobial activity of
moxifloxacin.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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