sitafloxacin and Pneumonia

Oral treatment for elderly outpatients with pneumonia is becoming increasingly important in this super-aged society from the perspective of cost-effectiveness and limited hospital capacities. We evaluated the efficacy and safety of two oral respiratory quinolones, sitafloxacin and garenoxacin, in elderly patients with pneumonia. This randomized, multicenter, open-label trial was conducted among patients aged ≥65 years with clinically and radiographically confirmed pneumonia in Japan. Patients were randomly assigned (1:1) to receive either sitafloxacin (100 mg/day) or garenoxacin (400 mg/day) for 3-10 days. The primary efficacy endpoint was the clinical cure rate at 5-10 days after the end of treatment. From December 2013 to November 2017, we enrolled 120 patients at 11 hospitals and randomly assigned 59 patients to the sitafloxacin group (1 patient withdrew) and 61 patients to the garenoxacin group. These included 30 patients with nursing and healthcare-associated pneumonia (NHCAP) (18 receiving sitafloxacin, 12 receiving garenoxacin) and 37 patients with aspiration pneumonia (16 receiving sitafloxacin, 21 receiving garenoxacin). The clinical cure rates in the sitafloxacin and garenoxacin groups were 88.5% (95% confidence interval: 76.6-95.6) and 88.9% (95% confidence interval: 77.4-95.8), respectively. No significant differences were observed in the incidence rates of drug-related adverse events between the sitafloxacin (20.7%; 12/58 patients) and garenoxacin (27.9%; 17/61 patients) groups. The most common adverse event was hepatic dysfunction, which occurred in seven patients in each group. We conclude that sitafloxacin and garenoxacin are comparably effective and safe for the treatment of pneumonia, including NHCAP and aspiration pneumonia, in elderly patients.

Topics: Aged; Aged, 80 and over; Anti-Bacterial Agents; Community-Acquired Infections; Female; Fluoroquinolones; Humans; Japan; Male; Pneumonia; Quinolones

This was a phase II, randomised, open-label, multi-centre study to assess the safety, tolerability, and efficacy of sitafloxacin (DU-6859a, 400 mg once daily) compared with imipenem (imipenem/cilastatin, 500 mg three times daily) in the treatment of hospitalised patients with pneumonia. Patients (n=69) were entered into the study in the intent-to-treat group, 35 in the sitafloxacin and 34 in the imipenem group. Patients (n=65) were included in the clinically evaluable population and 42 in the bacteriologically evaluable population. Baseline demographic data and clinical characteristics were similar for both treatment groups and across all patient populations. The incidence, severity and type of adverse events were similar in both treatment groups. The frequency of adverse events, which were considered to be related to the study of drugs was low and generally similar between the two groups. Mild transient increases in alanine aminotransferase and alkaline phosphatase occurred in the sitafloxacin treatment group, but there were no apparent trends in the other serum enzyme levels. The clinical response at the first and second follow-up assessments indicated that 94-97% of patients in the clinically evaluable population and 91% of patients in the intent-to-treat population were classified as cured in both treatment groups. The bacteriological response was classified as satisfactory for all patients (100%) in the bacteriologically evaluable population in the imipenem treatment group and satisfactory for 90 and 95% of cases at the first and second follow-up assessments in the bacteriologically evaluable population in the sitafloxacin treatment group, respectively. In conclusion, for the treatment of pneumonia, sitafloxacin was considered as safe and as tolerable as imipenem and preliminary data from this study suggest that it may have similar efficacy.

Topics: Adolescent; Adult; Aged; Alanine Transaminase; Alkaline Phosphatase; Anti-Infective Agents; Cilastatin; Drug Administration Schedule; Female; Fever; Fluoroquinolones; Follow-Up Studies; Humans; Imipenem; Male; Middle Aged; Molecular Structure; Pneumonia; Protease Inhibitors; Thienamycins

Topics: Adult; Aged; Anti-Bacterial Agents; Bronchoalveolar Lavage; Bronchoalveolar Lavage Fluid; Critical Illness; Female; Fluoroquinolones; Humans; Lung; Macrophages, Alveolar; Male; Middle Aged; Pneumonia; Respiratory Mucosa; Thailand

A 22-year-old woman was admitted to the hospital with complaints of fever, loss of appetite, coughing, sputum production, and right-sided chest pain. The chest X-ray film and computed tomogram showed infiltrates in both lower lung fields. Meningococcal pneumonia was diagnosed when a sputum culture was found to be positive for Neisseria meningitidis. Infection with this organism is uncommon in Japan. The patient had never gone abroad, and the route of infection was unknown. N. meningitidis is a rare cause of respiratory infections. When this organism does cause respiratory disease, it is usually acute bronchitis rather than meningococcal pneumonia. The patient in this case was not immunodeficient. She was also not deficient in a terminal lytic component sequence (deficiency in that sequence promotes meningococcal infection). The patient was emaciated and malnourished, which was thought to have made her more susceptible to infection. Orally administered DU-6859a, one of a new generation of quinolones, was very effective and had no side effects.

Topics: Adult; Anti-Infective Agents; Female; Fluoroquinolones; Humans; Meningococcal Infections; Pneumonia; Quinolones