Pharmacokinetics of Ceftriaxone Free Fraction (Infections)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Ceftriaxone Poisoning

Study type: Observational

Funder types: Other

Identifiers

NCT05061875

FIS-CEF-2021-01

Details and patient eligibility

About

Prospective observational follow-up study for the study and modeling of the pharmacokinetics of the free fraction of ceftriaxone in patients treated with high doses of ceftriaxone (greater than or equal to 4 grams per day).

Full description

A prospective follow-up observational study to study and model the pharmacokinetics of the ceftriaxone free fraction in patients treated with high doses of ceftriaxone (greater than or equal to 4 grams per day). it is a pilot study that has between 10 and 20 patients. This study will not condition the treatment of patients at any time.

The samples will be processed after their extraction. The concentration of the samples will be analyzed using a high-performance gilent infinity liquid chromatograph coupled to a mass spectrometer using positive or negative ionization using electrospray.

Enrollment: 20 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women over 55 years of age receiving treatment with high-dose ceftriaxone (minimum 4 grams / day) for any clinical indication in the study period.
• Creatinine <1.5 mg / dL
• The patient must have received at least 48 hours of treatment with the same previous therapeutic regimen to extraction.
• The subject or her representative must give their verbal or written consent to participate in the study. East Consent can be revoked at any time without prejudice to the patient.

The consent it will be recorded in your medical record.

Exclusion criteria

• Patients under 55 years of age.
• Creatinine> 1.5 mg / dL
• Patient with less than 48 hours of treatment with high-dose ceftriaxone.
• Subjects with allergy or hypersensitivity to cephalosporins and penicillins.
• Subjects who do not grant or withdraw their consent.
• Patients whose concomitant treatment presents possible interactions with the study medication. The possible interactions will be evaluated by staff of the Pharmacy Service.

Trial design

20 participants in 1 patient group

Cases

Description:

Patients treated with ceftriaxone doses equal to or higher 4 grams / day.