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Completed

NCT Number: NCT05221216

Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Collect data of medical record

Other

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))

Primary outcomes

  1. plasma concentrations of cotrimoxazole (mg/l)

    Time frame: From the antibiotic initiation until the patient is discharged from the ICU with a maximal time frame of 10 weeks

    pharmacokinetic cotrimoxazole

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 2, 2022
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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