Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

Acute Kidney Injury Clinical Trial

Official title:

Single-center Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221216
• Other study ID #: IRBN1452021/CHUSTE
• Status: Completed
• Start date: October 15, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• Collect data of medical record
Collect data of medical record: plasma concentrations of cotrimoxazole, demographic data (age, weight, height), data on the use of an extra renal replacement therapy (RRT) (date, type, number of sessions and duration of extra renal replacement therapy (RRT))

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentrations of cotrimoxazole (mg/l)	pharmacokinetic cotrimoxazole	From the antibiotic initiation until the patient is discharged from the ICU with a maximal time frame of 10 weeks