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The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan.
Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.
This study is seeking for patients with:
Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avibactam sodium/Ceftazidime hydrate | Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta (Avibactam sodium/Ceftazidime hydrate) for the first time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avibactam sodium/Ceftazidime hydrate | Drug | The recommended adult dosage is 2.5 g (0.5 g of avibactam and 2 g of ceftazidime) administered by intravenous infusion over a period of 2 hours 3 times daily. For peritonitis, intra-abdominal abscess, cholecystitis, and liver abscess, Zavicefta should be co-administered with a metronidazole injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with adverse drug reactions (ADRs) | From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinical Effectiveness | From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued) | |
| Number of Participants with Clinical Effectiveness at the time of Test of Cure |
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Inclusion Criteria:
Exclusion Criteria:
There are no exclusion criteria for this study.
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Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta for the first time
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D018805 | Sepsis |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| 28 days after the start of the administration |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |