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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
(1) Community-acquired pneumonia (CAP): 400 mg BID, i.e. every 12 ± 1 hours (For those with Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days. 2\) Hospital-acquired pneumonia (HAP): For the patient with Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1hours for 7 to 14 days For the patient with 30 ≤Ccr ≤60 mL/min, 400 mg BID, i.e. every 12 ± 1hours for 7 to 14 days 3) Secondary infection of chronic respiratory disease 400 mg BID, i.e. every 12 ± 1 hours (For those with of Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days.
Unnamed facility
Nagakute, Aichi-ken, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Kahoku-gun, Ishikawa-ken, Japan
Unnamed facility
Yokohama, Kanagawa, Japan
Unnamed facility
Isahaya, Nagasaki, Japan
Unnamed facility
Isahaya, Nagasaki, Japan
Unnamed facility
Nagasaki, Nagasaki, Japan
Unnamed facility
Nagasaki, Nagasaki, Japan
Unnamed facility
Nagasaki, Nagasaki, Japan
Unnamed facility
Sasebo, Nagasaki, Japan
...and 10 more locations
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: Up to 30 (±5) days after the end of treatment
AUC (Area under the blood concentration/time curve)
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax (Maximum observed concentration)
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
AUC/MIC (Minimum inhibitory concentration)
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax/MIC
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
AUC/MPC (Mutant prevention concentration)
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax/MPC
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
Clinical response rate based on resolution of signs and symptoms
Time frame: Up to 13 days after the first study drug administration
Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients
Time frame: Up to 23 days after the first study drug administration
Test of cure rate based on resolution of signs, symptoms, and the clinical response
Time frame: Up to 23 days after the first study drug administration
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