drugset / Trial / NCT03681431

Evaluation of an Antibiotic Regimen Pharmacokinetic Applicable to Enterococcus Faecalis Infective Endocarditis

NCT03681431

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

EvaluationDrugModalityDoseRoute
Subject Ceftriaxone Other / unclassified 2 g Intravenous
Subject Ceftriaxone Other / unclassified 4 g Intravenous