Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

NCT ID: NCT05221216

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2021-11-15

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients in Intensive Care unit

patients in Intensive Care unit with infection treated with cotrimoxazole will be included. Data will be collected of medical record.

Collect data of medical record

Intervention Type 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))

Interventions

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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))

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie PERINEL RAGEY, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN1452021/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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