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

NCT03681431 | Completed Phase 2

• 1 other identifier: ENDOKINETIC-CEF
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infectious Endocarditis

Keywords

Pharmacokinetic; Ceftriaxone; Enterococcus faecalis; Infectious Endocarditis

Outcome Measures

Primary Outcomes (1)

• Serum levels after 24 hours

  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 millilitre

  24 hours

Secondary Outcomes (6)

• AUC 24 hours

  24 hours

• Plasma Clearance

  24 hours

• Elimination Half-life

  24 hours

• Volume of Distribution

  24 hours

• Maximum Plasma Concentration

  24 hours

Study Arms (2)

Ceftriaxone 4g/ 24h

EXPERIMENTAL

Single intravenous dose of Ceftriaxone 4g/ 24h

Drug: Ceftriaxone 4g/ 24h

Ceftriaxone 2g/ 12h

ACTIVE COMPARATOR

Two intravenous doses of Ceftriaxone 2g/ 12h

Drug: Ceftriaxone 2g/ 12h

Interventions

Ceftriaxone 4g/ 24h DRUG

Each individual will be administrated 2 doses of 2 g of ceftriaxone separated for 12 hours. After a wash-out period (5-7 days) the same individuals will receive a single dose 4 g of ceftriaxone. In both cycles, plasma drug concentrations will be measure during 24 hours.

Ceftriaxone 4g/ 24h

Ceftriaxone 2g/ 12h DRUG

Each individual will be administrated 2 doses of 2 g of ceftriaxone separated for 12 hours. After a wash-out period (5-7 days) the same individuals will receive a single dose 4 g of ceftriaxone. In both cycles, plasma drug concentrations will be measure during 24 hours.

Ceftriaxone 2g/ 12h

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with clinically significant abnormalities in laboratory test or physical exploration. A medical check will be run by workers of Infectious Diseases Department.
• Subjects undergoing an active infection find at the screening.
• Subjects who has received treatment with cephalosporins 21 days before the trial starts or during the trial (apart from the protocol treatment).
• Subjects hypersensitive or allergic to cephalosporines or penicillins.
• Subjects undergoing chronic or acute cutaneous diseases which prevent the treatment administration.
• Subjects not giving his/her informed and signed consent approved by an Ethical Committee.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

University Hospital Virgen del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Endocarditis, Subacute Bacterial

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Endocarditis, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Cardiovascular Infections; Cardiovascular Diseases; Endocarditis; Heart Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Maria Victoria H Gil Navarro

  University Hospital Virgen del Rocio/ Institute of Biomedicine of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A phase II, single-centre, open, non-randomized, cross-over, clinical trial.

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: September 24, 2018
• Study Start: April 23, 2018
• Primary Completion: April 23, 2019
• Study Completion: May 23, 2019
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

ES (1)