An Evaluation of the Activity and Tolerability of Moxifloxacin during the first two months of Treatment for Pulmonary Tuberculosis (Study 27); A Pilot Study to Evaluate Nucleic Acid Amplification Tests to Predict Relapse of Tuberculosis and to Monitor the Effectiveness of Treatment (Study NAA)
Sponsor - U.S. Centers for Disease Control & Prevention - Tuberculosis Trials Consortium
Principal Investigator - John L. Johnson, MD, CWRU
|Type of Study||Phase 2 clinical trial of TB treatment with surrogate biomarker sub-studies|
|Design||Prospective , multi-center, randomized, placebo-controlled, double blind clinical trial evaluating the effect of using moxifloxacin in place of ethambutol, in combination with isoniazid, rifampin, and pyrazinamide on 2-months culture conversion rates among patients with sputum smear-positive pulmonary TB|
|Sample Size||Study 27: 300 subjects; Uganda Enrollment: 155 Study
NAA: 70 subjects; Uganda Enrollment: 44
|Population||HIV-infected and uninfected adults with initial episodes of newly diagnosed smear-positive, pulmonary TB|
|Study Period||September 2003-November 2005|
|Interactions||Collaborating investigators/staff, utilizing shared infrastructure|
TBTC Study 27
Current treatment of tuberculosis requires treatment for 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 MTB in preclinical testing. Furthermore, an initial clinical study in humans suggests that use of ofloxacin may allow tuberculosis treatment to be shortened to 4-5 months. 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. However, moxifloxacin has not been evaluated for tuberculosis treatment and has only been formally evaluated in treatment durations of 2 weeks or less. Therefore, there is a need to evaluate the safety of more prolonged dosing of moxifloxacin and to assess its activity against tuberculosis.
Final results of this completed study can be found in the following publication:
Burman WJ, Goldberg S, Johnson JL, Muzanye G, Engle M, Mosher AW, Choudhri S, Daley CL, Munsiff SS, Zhao Z, Vernon A, Chaisson RE and the Tuberculosis Trials Consortium. Moxifloxacin versus Ethambutol in the First 2 Months of Treatment for Pulmonary Tuberculosis. Am J Respir Crit Care Med. 2006; 174:331-338.