Preliminary report on DU-6859a for lower respiratory tract infection

The efficacy, safety, and clinical utility of DU-6859a, a novel "new quinolone" antibacterial agent, were evaluated in patients with mild-to-moderate pneumonia or chronic respiratory tract infection (RTI) in a multicenter study. DU-6859a was administered orally after meals at a dose of 50 to 100mg, mainly twice daily, for 6 to 14 days. The clinical efficacy rate was 100% (26/26) for pneumonia and 89% (66/74) for chronic RTI, for an overall clinical efficacy rate of 92% (92/100). The overall eradication rate of causative organisms was 76% (42/55). Among the main causative organisms, Streptococcus pneumoniae, Haemophilus influenzae, and Pseudomonas aeruginosa had eradication rates of 100% (14/14), 100% (13/13), and 27% (4/15), respectively. Side effects such as abdominal discomfort, soft stools, headache, or swelling of the face and lips were observed in 5.6% (6/107) of patients; most of these symptoms were mild. Abnormal laboratory test findings, such as elevation of glutamic-oxaloacetic transaminase and/or glutamic pyruvic transaminase, and eosinophilia, were noted in 16.5% (17/103) of patients; most of these abnormalities were mild. In conclusion, DU-6859a (50 to 100mg b.i.d.) showed excellent efficacy for pneumonia and chronic RTI without causing any severe, clinically significant adverse reactions. These findings show that DU-6859a is worthy of further clinical study for the treatment of RTI.