Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144417
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
2005-09-01
Brief Title:
TBTC Study 28 Moxifloxacin Versus Isoniazid for TB Treatment
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
TBTC Study 28 Evaluation of a Moxifloxacin-based Isoniazid-sparing Regimen for Tuberculosis Treatment
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None