Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB (Opti-Q)

Study Director
Charles R Horsburgh, MD
Start Date
1 / 2015
Trial Phase
Phase II
Trial Status
Current Enrollment
111 (April 2017)
Target Enrollment

TBTC 32/NIAID OPTI-Q Phase 2 study will determine the levofloxacin dose and exposure that achieves the greatest reduction in M. tuberculosis burden with acceptable tolerability by studying 100 adults with smear- and culture-positive pulmonary MDR-TB at sites in Peru and South Africa. Levofloxacin (11, 14, 17, 20 mg/kg) will be administered with an optimized background regimen (OBR) to: Determine the levofloxacin AUC/MIC that provides the shortest time to sputum culture conversion in solid medium. Determine the highest levofloxacin AUC that is both safe and associated with fewer than 25% of patients discontinuing or reducing their dose of levofloxacin. Develop a dosing algorithm to achieve the levofloxacin AUC associated with maximal efficacy and acceptable safety/tolerability.

Compound Associations