Pneumonia
Conditions
Keywords
Ciprofloxacin, Bacterial pneumonia, Community Acquired Pneumonia (CAP), Hospital Acquired Pneumonia (HAP), Secondary infection of chronic respiratory disease, 400 mg BID/TID
Brief 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.
Interventions
(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.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax/MPC | Within 0-24 hours and 48-72 hours after the first study drug administration |
| AUC/MIC (Minimum inhibitory concentration) | Within 0-24 hours and 48-72 hours after the first study drug administration |
| Cmax/MIC | Within 0-24 hours and 48-72 hours after the first study drug administration |
| AUC/MPC (Mutant prevention concentration) | Within 0-24 hours and 48-72 hours after the first study drug administration |
| Safety variables will be summarized using descriptive statistics based on adverse events collection | Up to 30 (±5) days after the end of treatment |
| AUC (Area under the blood concentration/time curve) | Within 0-24 hours and 48-72 hours after the first study drug administration |
| Cmax (Maximum observed concentration) | Within 0-24 hours and 48-72 hours after the first study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients | Up to 23 days after the first study drug administration |
| Test of cure rate based on resolution of signs, symptoms, and the clinical response | Up to 23 days after the first study drug administration |
| Clinical response rate based on resolution of signs and symptoms | Up to 13 days after the first study drug administration |
Countries
Japan
Outcome results
None listed