Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

Completed

• Conditions: Acute Kidney Injury
• Interventions: Other: Collect data of medical record

• Registration Number: NCT05221216
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Trimethoprim/sulfamethoxazole (TMP/SMX, cotrimoxazole) is the first-line therapy for Pneumocystis jirovecii pneumonia and bacterial infections in critically ill patients, where acute kidney injury (AKI) and renal replacement therapy (RRT) are regularly observed. Both may change half-life and subsequent concentrations. Specifically, Trimethoprim (TMP) is eliminated renally, whereas sulfamethoxazole (SMX) elimination is 80%metabolic/20%renal. Despite decades of cotrimoxazole use, data in acute kidney injury (AKI) are scarce and no consensus on dosing strategy has been established. Besides, pharmacodynamic parameter has not been determined, leading to an uncertainty on the dosing regimen.

Detailed Description

The objective is to compare the plasma concentrations of patients with acute renal failure (ARF) or requiring extra renal replacement therapy (RRT) with those of patients without these characteristics to look for differences in concentration.

Study Timeline

• Study Start: 2021-10-15
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Study First Submitted: 2021-12-31
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-31
• Last Update Submitted: 2022-01-31
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients in Intensive Care unit	Collect data of medical record	patients in Intensive Care unit with infection treated with cotrimoxazole will be included. Data will be collected of medical record.

Primary Outcome Measures

Name	Time	Method
plasma concentrations of cotrimoxazole (mg/l)	From the antibiotic initiation until the patient is discharged from the ICU with a maximal time frame of 10 weeks	pharmacokinetic cotrimoxazole

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Etienne, France