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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin (Cipro, BAYQ3939) | Drug | (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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| Cmax/MPC | Within 0-24 hours and 48-72 hours after the first study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate based on resolution of signs and symptoms | Up to 13 days after the first study drug administration | |
| Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients | Up to 23 days after the first study drug administration |
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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
Secondary infection of chronic respiratory disease
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagakute | Aichi-ken | 480-1195 | Japan | |||
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|
| Test of cure rate based on resolution of signs, symptoms, and the clinical response | Up to 23 days after the first study drug administration |
| Kobe |
| Hyōgo |
| 650-0047 |
| Japan |
| Kahoku-gun | Ishikawa-ken | 920-0293 | Japan |
| Yokohama | Kanagawa | 232-0024 | Japan |
| Isahaya | Nagasaki | 854-8501 | Japan |
| Isahaya | Nagasaki | 859-0497 | Japan |
| Nagasaki | Nagasaki | 850-8555 | Japan |
| Nagasaki | Nagasaki | 852-8501 | Japan |
| Nagasaki | Nagasaki | 852-8511 | Japan |
| Sasebo | Nagasaki | 857-8511 | Japan |
| Unzen | Nagasaki | 854-0301 | Japan |
| Niigata | Niigata | 950-1197 | Japan |
| Niigata | Niigata | 950-2087 | Japan |
| Niigata | Niigata | 951-8520 | Japan |
| Yufu | Oita Prefecture | 879-5593 | Japan |
| Okayama | Okayama-ken | 700-8607 | Japan |
| Kishiwada | Osaka | 596-8501 | Japan |
| Osaka | Osaka | 543-0035 | Japan |
| Ureshino | Saga-ken | 843-0393 | Japan |
| Hamamatsu | Shizuoka | 434-8511 | Japan |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D018410 | Pneumonia, Bacterial |
| D000098968 | Community-Acquired Pneumonia |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D017714 | Community-Acquired Infections |
| D003428 | Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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