Evaluation of an Antibiotic Regimen Pharmacokinetic Applicable to Enterococcus Faecalis Infective… (NCT03681431) | Clinical Trial Compass
CompletedPhase 2
Evaluation of an Antibiotic Regimen Pharmacokinetic Applicable to Enterococcus Faecalis Infective Endocarditis
Spain12 participantsStarted 2018-04-23
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female adults subjects.
✓. Weight between 40 and 105 kilograms, both included, and body mass index lower than 34 kilograms per square meter.
✓. The subject (or his/her "trusted representative") must have given his/her informed and signed consent approved by an Ethical Committee.
✓. The subject must have normal analytical values or abnormal without clinical significance of biochemical parameters, liver and kidney function panel test, hemogram and album level. A medical check will be run by workers of Infectious Diseases Department.
✓. The subject must have a normal physical examination or abnormal without clinical significance. A medical check will be run by workers of Infectious Diseases Department.
✓. The medication taken usually by the subjects will be check by the Pharmacy Department in order to find possible interactions with ceftriaxone.
Exclusion criteria
✕. Subjects with clinically significant abnormalities in laboratory test or physical exploration. A medical check will be run by workers of Infectious Diseases Department.
What they're measuring
1
Serum levels after 24 hours
Timeframe: 24 hours
Trial details
NCT IDNCT03681431
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla