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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients treated with ceftriaxone doses equal to or higher 4 grams / day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration [Cmax] | Determine the maximum plasma concentration of ceftriaxone after the administration of high doses (equal to or greater than 4 grams / day). | Up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the plasma concentration of the free fraction of ceftriaxone 24 hours after the administration of the daily dose (trough level) in patients receiving doses equal to or greater than 4 grams / day. | Plasma concentration of the free fraction of ceftriaxone after 24 hours of the start of the daily dose (trough level) in patients treated with doses at or above 4 grams / day. | Up to 24 weeks. |
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Inclusion Criteria:
The consent it will be recorded in your medical record.
Exclusion Criteria:
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Patients treated with ceftriaxone doses equal to or higher 4 grams / day. This study will in no case condition the treatment of patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Victoria Gil Navarro | Contact | 955012300 | mariav.gil.sspa@juntadeandalucia.es | |
| Carlos García Pérez | Contact | 955 04 31 27 | administracion.eecc.hvm.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Maria Victoria Gil Navarro | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
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| Determine the plasma concentration of the free fraction of ceftriaxone during 24 hours in patients receiving doses equal to or greater than 4 grams / day. | Plasma concentration of the free fraction of ceftriaxone for 24 hours in patients receiving doses equal to or greater than 4 grams / day. | Up to 24 weeks. |
| Ceftriaxone plasma clearance. | determine the plasma clearance of ceftriaxone in patients receiving doses equal to or greater than 4 grams / day. | Up to 24 weeks. |