NCT04257812

Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine the Ceftolozane-Tazobactam Plasmatic Levels and and analyse the clinical impact that might have the dose regimens that have been used until now.

Conditions

• Serious Infection

Interventions

Type	Name	Description
DRUG	Ceftolozane/tazobactam	The dose will be 1g ceftolozane + 0,5 g tazobactam every 8 hours or 2 g ceftolozane + 1 g tazobactam, it´s recommended to use this last dose regimen in patients with pneumonia or septic shock of any focus. The patients will be followed as it´s done habitually. There will be done infection focus cultures and others according to usual clinical practice. It´ll be determined the clinical response and mortality in the days 14 and 30 after the beginning of the medicine, respectively. The Ceftolozane-Tazobactam levels determination will always be made in state of equilibrium (after the third dose). Four samples will be collected: 1. Just before the antibiotic infusion. 2. One hour after the antibiotic infusion. 3. Three hours after the antibiotic infusion. 4. Six hours after the antibiotic infusion.

Timeline

• Start date: 2020-02-15
• Primary completion: 2021-03-15
• Completion: 2022-06-15
• First posted: 2020-02-06
• Last updated: 2020-02-06

Locations

1 site across 1 country: Spain