Trial · NCT05655091
Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection
NCT05655091, Phase 2, Recruiting, University Hospital, Basel, Switzerland
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection. Trials, record NCT05655091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05655091
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection
- NCT number
- NCT05655091
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 36 participants, estimated
- Lead sponsor
- University Hospital, Basel, Switzerland
- Conditions
- Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)
- Interventions
- FLU or CZO as continuous infusion, standard FLU or CZO intermittent bolus administration
- First posted
- 2022-12-16
- Last updated
- 2024-12-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients that attain the (FLU or CZO) target concentration (100% fT 2 to 12 mg/L) in blood. | On day 3 after inclusion | For the assessment of the primary endpoint (100% fT 2 to 12 mg/L), the plasma concentration of FLU or CZO will be measured at day 3 after inclusion of the patient. |
| Secondary | Proportion of patients attaining the target (FLU or CZO) concentration at second TDM | At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge | Change in plasma concentration of FLU and CZO will be measured |
| Secondary | Incidence of high (e.g. 100% fT>12 mg/L) (FLU or CZO) concentrations | At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge | Incidence of high (e.g. 100% fT\>12 mg/L) (FLU or CZO) concentrations |
| Secondary | Incidence of low concentrations (e.g. 100% fT<2mg/L) (FLU or CZO) concentrations | At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge | Incidence of low concentrations (e.g. 100% fT\<2mg/L) (FLU or CZO) concentrations |
| Secondary | Incidence of potential drug-related toxicity during the course of treatment (e.g. nephrotoxicity, hepatotoxicity, neurotoxicity) | From Day 0 (enrolment) until discharge (up to 6 weeks) | Incidence of potential drug-related toxicity during the course of treatment (e.g. nephrotoxicity, hepatotoxicity, neurotoxicity) |
| Secondary | Percentage of days with optimal target attainment in relation to total study treatment duration | From Day 0 (enrolment) until discharge (up to 6 weeks) | Percentage of days with optimal target attainment in relation to total study treatment duration |
| Secondary | Intra-individual variability in FLU und CZO total and unbound plasma concentrations | At day 1, 3, 5, 7, 10 and thereafter two times weekly until treatment period is completed (i.e. up to 6 weeks) or until discharge | Intra-individual variability in FLU und CZO measured by change in plasma concentrations (total and unbound) |
| Other | Change in drug concentration of penicillin (in patients in whom treatment was changed from FLU or CZO to penicillin (Outcome of sub-study I)) | From Day 1 after enrolment until treatment period is completed (i.e. up to 6 weeks) | Change in drug concentration of penicillin (in patients in whom treatment was changed from FLU or CZO to penicillin (Outcome of sub-study I)) |
| Other | Rest-activity rhythms in patients admitted to a general ward (Outcome of sub-study II) | From Day 0 (enrolment) until until end of treatment (up to 6 weeks) | Rest-activity rhythms will be assessed by actigraphy. The actigraph will be worn on the non-dominant wrist all the time during the hospital stay. If patients are discharged, actigraphy will be continued as long as antibiotic treatment will be maintained. |
| Other | Change in Sequential Organ Failure Assessment (SOFA) score | From Day 0 (enrolment) until day 10 | The Sequential Organ Failure Assessment (SOFA) score numerically quantifies the number and severity of failed organs. The SOFA score is made of 6 variables, each representing an organ system. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05655091
GET https://conductscience.org/api/trials/v1/NCT05655091/registered