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| ID | Type | Description | Link |
|---|---|---|---|
| BAC-1002 | Other Identifier | Basilea Internal Reference |
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The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers.
This is an open-label, single center study to investigate the effect on human intestinal microflora of multiple doses of ceftobiprole treatment administered at 8 hours intervals for 7 consecutive days. Careful investigation of the effect of Ceftobiprole treatment on the intestinal microflora is of importance since alteration of the intestinal microflora balance may facilitate colonization by pathogenic bacteria strains or enable microorganisms already present in the normal microflora to develop resistance. A total of 7 fecal samples will be collected on day 2, 4, 7, 10, 14 and 21 for determination of ceftobiprole concentration in fecal, intestinal microflora pattern and measuring the susceptibility for Ceftobiprole of isolated bacterial strains. A total of 13 plasma samples will be collected on day 1, 4, 7, 10, 14 and 21 for determination of ceftobiprole concentration in plasma. Safety evaluations including physical examination, vital signs, clinical laboratory tests, electrocardiogram and adverse event monitoring will be performed throughout the study. 500 mg ceftobiprole, intravenous infusion over 120 minutes, every 8 hours for 7 consecutive days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftobiprole | Experimental | Ceftobiprole 500 mg by 2 hour intravenous infusion every 8 hours for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftobiprole | Drug | ceftobiprole 500 mg by intravenous infusion every 8 hours for 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Bacterial strains and numbers in feces; Minimum inhibitory concentrations for ceftobiprole for isolated resistant strains | Day 2, 4, 7, 10, 14 and 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal concentration of ceftobiprole | Day 2, 4, 7, 10, 14 and 21 | |
| Plasma Concentration of ceftobiprole | Day 1, 4, 7, 10, 14, and 21 |
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Inclusion Criteria:
- Healthy volunteers with body weight >= 50 kg and body mass index between 18 and 30
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20926263 | Result | Backstrom T, Panagiotidis G, Beck O, Asker-Hagelberg C, Rashid MU, Weintraub A, Nord CE. Effect of ceftobiprole on the normal human intestinal microflora. Int J Antimicrob Agents. 2010 Dec;36(6):537-41. doi: 10.1016/j.ijantimicag.2010.07.021. |
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| ID | Term |
|---|---|
| C443755 | ceftobiprole |
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