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This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cefepime-taniborbactam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cefepime-taniborbactam | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| ELF Cmax | Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF) | 0-8 hours after 6th dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Day 1 - Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates PA | Phoenix | Arizona | 85032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40476839 | Derived | Rodvold KA, Gotfried MH, Sabato P, Henkel T, McGovern PC. Plasma and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult participants. Antimicrob Agents Chemother. 2025 Jul 2;69(7):e0049325. doi: 10.1128/aac.00493-25. Epub 2025 Jun 6. |
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