Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

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Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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GET https://conductscience.org/api/trials/v1/NCT05655091/registered

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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).
Other	Time to first negative blood culture	From Day 0 (enrolment) until discharge (approx. 2 weeks)	Time to first negative blood culture
Other	Change in inflammation parameters (C-reactive protein)	From Day 0 (enrolment) until end of treatment (up to 6 weeks)	Change in inflammation parameters (C-reactive protein)
Other	Change in All-cause mortality rate at day 30 and day 90	At day 30 and day 90 after enrolment	Change in All-cause mortality rate
Other	Quality of life using the EuroQol™ 5D-5L Questionnaire	At day 90 after enrolment	EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. (Score 0 to 100: 100 means the best health you can imagine. 0 means the worst health you can imagine).
Other	Serious adverse events	From Day 1 after enrolment until three month follow-up	All serious adverse events will be assessed and documented by the investigators according to seriousness, intensity, causal relationship with study treatment, action taken with study treatment (e.g. withdrawal), specific treatment for serious adverse event and outcome.