Staphylococcus Aureus InfectionDOSESACLOXANCT06495697
Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia
An observational study of Staphylococcus Aureus Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Infection
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2023to 19 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient having expressed his opposition to the reuse of his data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
Baptiste HOELLINGER, MD, 33 3 69 55 05 45, baptiste.hoellinger@chru-strasbourg.fr
Baptiste HOELLINGER, MD
About this study
Official title: Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia - Single-center Retrospective Study
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
- Medical subject headings
- Staphylococcal Infections, Endocarditis, Subacute Bacterial
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical healing
Blood culture negative at 48-96 hours compared to the start of antibiotic therapy
Measured: day 30 after infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start19 Jul 2023
- Primary completionJul 2024 (estimated)
- Study completion19 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495697
- Sponsor's protocol ID
- 9023
- Acronym
- DOSESACLOXA
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia - Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06495697
- Acronym / sponsor ID
- DOSESACLOXA / 9023
- Conditions
- Staphylococcus Aureus Infection
- Keywords
- Staphylococcus aureus Infection, Staphylococcus aureus bacteremia, Penicillins, Methicillin-sensitive, Cefazolin, Infectious endocarditis, Staphylococcal endocarditis, Oxacillin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- 19 Jul 2024 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient having expressed his opposition to the reuse of his data for scientific research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical healing
Time frame: day 30 after infection
Blood culture negative at 48-96 hours compared to the start of antibiotic therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus Infection, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baptiste HOELLINGER, MD (33 3 69 55 05 45, baptiste.hoellinger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical healing (time frame: day 30 after infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.