AZD5847 Randomized, Open Label, Multiple Dose Phase 2a Study of the Early Bactericidal Activity of AZD5847 in Adults With Pulmonary Tuberculosis

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AZD5847 is an oxazolidinone antibiotic with in vitro activity against Mycobacterium tuberculosis. The objective of this study was to evaluate the antimycobacterial activity, safety, and pharmacokinetics of AZD5847 in patients with pulmonary tuberculosis. Groups of 15 treatment-naive, sputum smear-positive adults with pulmonary tuberculosis were randomly assigned to receive AZD5847 at one of four doses (500 mg once daily, 500 mg twice daily, 1,200 mg once daily, and 800 mg twice daily) or daily standard chemotherapy.

NC-003

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The New Combination 3 (NC-003) clinical trial tested the BPaZ regimen, consisting of bedaquiline, PA-824, and pyrazinamide. The two-week study found that the BPaZ regimen killed more than 99% of TB bacteria over the course of 14 days, and that the treatment was safe. The trial also tested multiple clofazimine-containing TB treatment regimens in combination with PA-824 and bedaquiline.

About the New Treatment(s)

TBTC Study 32, Opti-Q

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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.

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