A Phase 1 interventional study of Ceftobiprole in Obesity, Staphylococcal Skin Infections and Streptococcal Infections, sponsored by Basilea Pharmaceutica. Completed. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-28.
Sponsored by Basilea Pharmaceutica · Phase 1, Interventional, and Basic science
The primary objective of this study is to compare the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.
This is an open-label (all people involved know the identity of the intervention), parallel-group, Phase 1 study in morbidly obese and non-obese men and women. A total of 25 patients (12 morbidly obese and 13 non-obese) patients will be enrolled in the study. Morbidly obese and nonobese patients are matched individually 1:1 by age (±10 years), sex, and renal function (as defined by creatinine levels in the urine). There are 4 phases in the clinical study: the pretreatment (screening/baseline) phase of up to 21 days; the 2-day open-label treatment phase when each patients receives a single 2-hour intravenous (directly into the vein) infusion of ceftobiprole 500 mg followed by multiple (up to 15) blood and urine samples drawn over the 24 hours following study drug administration; and the follow-up phase of approximately 1 week after the last blood sample when each patient will be monitored by telephone for development of new adverse events and assessment of ongoing adverse events. Each patient receives a single 2-hour infusion (directly into the vein) of ceftobiprole 500 mg
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 25 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Basilea Pharmaceutica is the lead sponsor of 56 studies on the registry; 5 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 15 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ceftobiprole 500 mg single-dose over 2 hours.
Drug: Ceftobiprole
Ceftobiprole 500 mg single-dose over 2 hours.
Drug: Ceftobiprole
Ceftobiprole, 500 mg as single iv infusion over 2 hours
The pharmacokinetics of ceftobiprole in morbidly obese patients and non-obese patients
Time frame: up to 30 days (up to 21 days screening plus 2 days open-label treatment phase plus 1-week follow-up).
To assess the pharmacodynamics of ceftobiprole in morbidly obese patients and non-obese patients.
Time frame: Up to 30 days (up to 21 days screening plus 2 days open label treatment phase plus 1-week follow-up)
To assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.
Time frame: Throughout the study from Day -1 through the post-study follow up
No study locations are listed for this record.
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Basilea Pharmaceutica