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| ID | Type | Description | Link |
|---|---|---|---|
| CIPRO-IV-2010 | Other Identifier | company internal |
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This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily practice.It is a local prospective and observational study of patients who have received Ciproxan intravenously for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to be enrolled and assessed during the period of treatment with Ciproxan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patient treated with Ciproxan without dilution treatment in daily clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cipro (Ciprofloxacin, BAYQ3939) | Drug | Patient treated with Ciproxan without dilution treatment in daily clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) | After 8 days | |
| Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion | After 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| ADR incidence rates classified by patient's background factors | After 8 days | |
| Efficacy rate calculated with Response and Minor Response considered as responder | After 8 days | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who received Ciproxan iv administration without dilution in the daily practice among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Japan |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D018805 | Sepsis |
| D011014 | Pneumonia |
| D010538 | Peritonitis |
| D002764 | Cholecystitis |
| D002761 | Cholangitis |
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| 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 |
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| Efficacy rates classified by patient's background factors |
| After 8 days |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D059413 | Intraabdominal Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D001649 | Bile Duct Diseases |
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |