drugset / Trial / NCT03681431
Evaluation of an Antibiotic Regimen Pharmacokinetic Applicable to Enterococcus Faecalis Infective Endocarditis
Non-randomizedCrossoverOpen-labelTreatment
Summary
The clinical trial is designed as a phase II, crossover clinical trial. It will be carried out in healthy volunteers, who will receive two different antibiotic regimen based on ceftriaxone. One of the regimens had shown clinical effectiveness in this scenario, but it is not suitable for OPAT programs. In the other hand, a new treatment schema useful in OPAT programs is proposed, but there is still a lack of pharmacokinetic data to support it. The plasma drug concentrations will be measured in both cases, comparing the minimal drug concentration observed and the pharmacokinetic profiles of the two regimens.
Timeline
- Start
- 2018-04-23
- Primary completion
- 2019-04-23
- Completion
- 2019-05-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceftriaxone | Other / unclassified | 2 g | Intravenous |
| Subject | Ceftriaxone | Other / unclassified | 4 g | Intravenous |