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Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe confirmed Clostridium difficile associated diarrhea (CDAD).
Details
| Lead sponsor | Gary E. Stein, Pharm.D. |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 10 |
| Start date | 2011-07 |
| Completion | 2013-07 |
Conditions
- Diarrhea
- Clostridium Difficile
Interventions
- Tigecycline
Primary outcomes
- Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile — day 3 of treatment
Serum levels of tigecycline - Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates — day 1 stool sample
- Mean (SD) Serum Tigecycline Concentration Level — day 3 of tigecycline therapy
Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay. - Mean (SD) Stool Tigecycline Concentration Level — day 3 of tigecycline therapy
Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay - Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile — day 3 of treatment
Stool levels of tigecycline
Countries
United States