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RecruitingNCT06495697DOSESACLOXAUpdated Jul 11, 2024

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

An observational study in Staphylococcus Aureus Infection, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Staphylococcus Aureus Infection

Keywords

  • Staphylococcus aureus Infection
  • Staphylococcus aureus bacteremia
  • Penicillins
  • Methicillin-sensitive
  • Cefazolin
  • Infectious endocarditis
  • Staphylococcal endocarditis
  • Oxacillin
  • Nephrotoxicity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patient having expressed his opposition to the reuse of his data for scientific research purposes.
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Clinical healing

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

    Time frame: day 30 after infection

06

Study locations

1 of 1 sites recruiting
  • Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
    Strasbourg, 67091, France
    • Baptiste HOELLINGER, MD · Contact · baptiste.hoellinger@chru-strasbourg.fr · 33 3 69 55 05 45
    • Baptiste HOELLINGER, MD · Principal investigator
    • Yvon Ruch, MD · Sub investigator
    • Suson PASTRES, MD · Sub investigator
    • Jeanne MALLICK, MD · Sub investigator
    • Elodie TREAL, MD · Sub investigator
    • Jordan LE GRAND GAC, MD · Sub investigator
    • Axel Ursenbach, MD · Sub investigator
    • François SEVERAC, Statistician · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06495697
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jul 11, 2024
Start date
Jul 19, 2023
Primary completion
Jul 2024 (estimated)
Completion
Jul 19, 2024 (estimated)
Last update
Jul 11, 2024

Study contacts

Baptiste HOELLINGER, MD
Contact
baptiste.hoellinger@chru-strasbourg.fr
33 3 69 55 05 45

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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