Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT05221216
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Actual Duration (Months): 1
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Other: Collect data of medical record

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 Design

• Study Type: Observational
• Actual Enrollment: 5 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Single-center Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit
• Actual Study Start Date: Oct 15, 2021
• Actual Primary Completion Date: Nov 15, 2021
• Actual Study Completion Date: Nov 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; 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))

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Saint-Etienne	Saint-Etienne		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Sophie PERINEL RAGEY, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT05221216
• Other Study ID Numbers: IRBN1452021/CHUSTE
• First Posted: Feb 2, 2022
• Last Update Posted: Feb 2, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: cotrimoxazole; Acute Kidney Injury; renal replacement therapy; pharmacodynamic
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Feb 2, 2022