a phase iii study to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of bayq3939 in patients with bacterial pneumonia

Conditions: Pneumonia

Summary: the main objective of this study is to investigate the safety, pharmacokinetics (pk) and the relationship between pk and pharmacodynamics (minimum inhibitory concentration \[mic\] and mutant prevention concentration \[mpc\]) of intravenous bayq3939 (400 mg bid and 400 mg tid) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. in addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.


Eligibility criteria:
inclusion criteria: * males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older. * within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage \[bal\], protected brushing specimen \[pbs\]), or should have appropriate specimens highly likely to identify the pathogens sampled. (however, the patients with legionellosis is enrolled when the test of legionella antigen is positive.) * the following severe bacterial pneumonia meeting the diagnostic criteria of pneumonia or secondary infection of chronic respiratory disease * severe pneumonia * community-acquired pneumonia: port score iii, iv or v * hospital-acquired pneumonia \[hap\]-group b and with a low risk for multidrug-resistant pathogens * patients with \[hap\]-group a whose pathogen is suspected to be pseudomonas aeruginosa * hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials note: the patients should be limited to cap patients with port score iii, iv or v and hap patients with-group a or b who don't respond to or have a poor response to other antimicrobials over 3day's treatment.2 * secondary infection of chronic respiratory disease * patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease * hospitalized patients with secondary infection of chronic respiratory disease with a poor response to other antimicrobials note: the patients should be limited to secondary infection of chronic respiratory disease patients who don't respond to or have a poor response to other antimicrobials over 3day's treatment. exclusion criteria: * creatinine clearance (ccr) ≤ 30 ml/min or nephrotic syndrome * patient with chronic treatment of immunosuppressive drug * decompensated congestive heart failure * subject who received more than 24 hours of an antibacterial drug for the current infection * patient who requires intensive care unit (icu) management \[in case subjects who don't correspond to the severity for icu management need to be admitted to icu due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded\] * patients with infections other than pneumonia or secondary infection of chronic pulmonary disease * lung abscess, or empyema * viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis * known or suspected bacteremia secondary to staphylococcus aureus * known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of streptococcus pneumonia * infection that necessitates the use of a concomitant antibacterial agent in addition to study medication \[excluding subjects with concomitant use of long-term, low-dose macrolide for chronic respiratory diseases, sulbactam sodium/ampicillin sodium (unasyn-s) and clindamycin (dalacin-s)\] * known bronchial obstruction or a history of post-obstructive pneumonia * known primary lung cancer

Keywords: ciprofloxacin bacterial pneumonia community acquired pneumonia (cap) hospital acquired pneumonia (hap) secondary infection of chronic respiratory disease 400 mg bid/tid