Phase II clinical trial to evaluate an antibiotic regimen pharmacokinetic applicable to outpatient parenteral antimicrobial therapy in Enterococcus faecalis infective endocarditis

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003127-29-ES

Enrollment

Registered

2017-12-21

Start date

2018-02-26

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers (Enterococcus faecalis infective endocarditis) MedDRA version: 20.1 Level: LLT Classification code 10014892 Term: Enterococcus faecalis endocarditis System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10053349 Term: Pharmacokinetic study System Organ Class: 100000004848

Interventions

Trade Name: Ceftriaxona Product Name: Ceftriaxone Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: CEFTRIAXONE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female adults subjects. 2. Weight between 40 and 18 kilograms, both included, and body mass index lower than 34 kilograms per square meter. 3. The subjetct (or his/her "trusted representative") must have given his/her informed and signed consent approved by an Ethical Committee. 4. The subjetc 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. 5. The subjetc must have a normal physical examination or abnormal without clinical significance. A medical check will be run by workers of Infectious Diseases Department. 6. The medication taken usually by the subjects will be check by the Pharmacy Department in order to find possible interactions with ceftriaxone. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Subjects with clinically significant abnormalities in laboratory test or physical exploration. A medical check will be run by workers of Infectious Diseases Department. 2. Subjects undergoing an active infection find at the screening. 3. Subjects with any clinical or surgery condition which contraindicate his/her inclusion, check by workers of Infectious Diseases Department. 4. Subjects who has recieved treatment with cephalosporins 21 days before the trial starts or during the trial (apart from the protocol treatment). 5. Subjects hypersensitive or allergic to cephalosporines or penicillins. 6. Subjetcs undergoing chronic or acute cutaneous diseases which prevent the treatment administration. 7. Subjetct not giving his/her informed and signed consent approved by an Ethical Committee.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determinate whether 24 hours after the administration of 4 grams of ceftriaxone in a single short infusion, serums levels would be higher than 5 micrograms per mililitre; Secondary Objective: 1. To compare the 24 hours area under the curve (AUC) after the administration of 4 grams of ceftriaxone in a single short infusion and the administration of 2 grams of ceftriaxone in a two short infusions separated for 12 hours. 2. To determinate all dose-dependants pharmacokinetics parameters after the administration of 4 grams of ceftriaxone in a single short infusion. 3. To determinate the safety of the administration of 4 grams of ceftriaxone in a single short infusion ;Primary end point(s): Serums levels of ceftriaxone 24 hours after the administration of 4 grams of ceftriaxone in a single short infusion.;Timepoint(s) of evaluation of this end point: 24 hours after the administration of ceftriaxone	—

Measure

Time frame

Main Objective: To determinate whether 24 hours after the administration of 4 grams of ceftriaxone in a single short infusion, serums levels would be higher than 5 micrograms per mililitre; Secondary Objective: 1. To compare the 24 hours area under the curve (AUC) after the administration of 4 grams of ceftriaxone in a single short infusion and the administration of 2 grams of ceftriaxone in a two short infusions separated for 12 hours. 2. To determinate all dose-dependants pharmacokinetics parameters after the administration of 4 grams of ceftriaxone in a single short infusion. 3. To determinate the safety of the administration of 4 grams of ceftriaxone in a single short infusion ;Primary end point(s): Serums levels of ceftriaxone 24 hours after the administration of 4 grams of ceftriaxone in a single short infusion.;Timepoint(s) of evaluation of this end point: 24 hours after the administration of ceftriaxone

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Secondary

Measure	Time frame
Secondary end point(s): 1. Serums levels of ceftriaxone 0.5, 1, 2, 3, 6, 8, 10, 12, 16 y 20 and 24 hours after the administration of 4 grams of ceftriaxone in a single short infusion. 2. Dose-dependants pharmacokinetics parameters after the administration of 4 grams of ceftriaxone in a single short infusion: plasma clearance and volume of distribution. 3. Significant differences between serums levels of ceftriaxone 24 hours after the administration of 4 grams of ceftriaxone in a single short infusion and serums levels of ceftriaxone 24 hours after the administration of 2 grams of ceftriaxone in two short infusion separated for 12 hours. 4. Number of adverse reactions after the administration of 4 grams of ceftriaxone in a single short infusion. 5. Frequency and importance of adverse reactions. ; Timepoint(s) of evaluation of this end point: 1. 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20 and 24 hours after the administration of ceftriaxone. 2 and 3. 24 hours after the administration of ceftriaxone . 4 and 5. 24 hours, 1 week and 1 month after the administration of ceftriaxone .	—

Measure

Time frame

Secondary end point(s): 1. Serums levels of ceftriaxone 0.5, 1, 2, 3, 6, 8, 10, 12, 16 y 20 and 24 hours after the administration of 4 grams of ceftriaxone in a single short infusion. 2. Dose-dependants pharmacokinetics parameters after the administration of 4 grams of ceftriaxone in a single short infusion: plasma clearance and volume of distribution. 3. Significant differences between serums levels of ceftriaxone 24 hours after the administration of 4 grams of ceftriaxone in a single short infusion and serums levels of ceftriaxone 24 hours after the administration of 2 grams of ceftriaxone in two short infusion separated for 12 hours. 4. Number of adverse reactions after the administration of 4 grams of ceftriaxone in a single short infusion. 5. Frequency and importance of adverse reactions. ; Timepoint(s) of evaluation of this end point: 1. 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20 and 24 hours after the administration of ceftriaxone. 2 and 3. 24 hours after the administration of ceftriaxone . 4 and 5. 24 hours, 1 week and 1 month after the administration of ceftriaxone .

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Countries

Spain

Contacts

Public ContactLaura Herrera Hidalgo

Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla. (FISEVI)

laura.herrera.sppa@juntadeandalucia.es+34955012095

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026