Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia

NCT06495697 | Recruiting

• 1 other identifier: 9023
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of Methicillin-sensitive Staphylococcus aureus bacteremia is based on the first-line use of cefazolin or M penicillins (oxacillin and cloxacillin). The use of the latter is recommended at high doses (150-200 mg/kg/24h). In a study on infectious endocarditis, 52 of 56 patients with staphylococcal endocarditis treated with (cl)oxacillin were overdosed with the recommended doses. Although the main mechanism of renal toxicity described for M penicillins is immunoallergic, a frequent overdose is observed in cases of acute renal failure with M penicillins. There is also a significant association between overdose and risk of neurological toxicity. The currently recommended treatment duration is a minimum of 14 days of IV treatment from the first negative blood culture, which leaves room for carrying out a plasma assay and possible dosage adjustment subsequently. Overdose is a risk factor for nephrotoxicity and neurotoxicity. Plasma level could be predictive of clinical success. Systematic plasma dosing would reduce the risk of toxicity and improve the clinical cure rate.

Conditions

Staphylococcus Aureus Infection

Keywords

Staphylococcus aureus Infection; Staphylococcus aureus bacteremia; Penicillins; Methicillin-sensitive; Cefazolin; Infectious endocarditis; Staphylococcal endocarditis; Oxacillin; Nephrotoxicity

Outcome Measures

Primary Outcomes (1)

• Clinical healing

  Blood culture negative at 48-96 hours compared to the start of antibiotic therapy

  day 30 after infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient (≥18 years old) having presented an infection with Staphylococcus aureus and treated at the University Hospitals of Strasbourg between January 1, 2019 and December 31, 2022.

You may qualify if:

• Adult patient (≥18 years old)
• Having presented an infection with Staphylococcus aureus and treated at the University Hospitals of Strasbourg between January 1, 2019 and December 31, 2022.

You may not qualify if:

• \- Patient having expressed his opposition to the reuse of his data for scientific research purposes.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections; Endocarditis, Subacute Bacterial

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Endocarditis, Bacterial; Streptococcal Infections; Cardiovascular Infections; Cardiovascular Diseases; Endocarditis; Heart Diseases

Central Study Contacts

Baptiste HOELLINGER, MD

CONTACT

33 3 69 55 05 45; baptiste.hoellinger@chru-strasbourg.fr

Study Design

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

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: July 11, 2024
• Study Start: July 19, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 19, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-04

Locations

FR (1)