Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

NCT05221216 | Completed

• 1 other identifier: IRBN1452021/CHUSTE
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

cotrimoxazole; Acute Kidney Injury; renal replacement therapy; pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: Collect data of medical record

Interventions

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))

patients in Intensive Care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole will be included.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sophie PERINEL RAGEY, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: February 2, 2022
• Study Start: October 15, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)