Trial · NCT07550595
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Desirability of Outcome Ranking (DOOR) at Day 70 | Day 70 post-enrolment | Composite ordinal outcome adapted for Gram-positive cardiac infections. Participants will be ranked from most to least desirable outcome as follows: 1. = alive with no clinical failure, infectious complication, or serious adverse event/adverse event leading to study drug discontinuation; 2. = alive with 1 of these events; 3. = alive with 2 of these events; 4. = alive with all 3 of these events; 5. = death. Within each rank, ties will be resolved using net change in EQ-5D score from baseline to Day 70, with greater improvement indicating a more desirable outcome. |
| Secondary | Total oritavancin plasma concentration at scheduled sampling time points | From post-dose Day 1 through Day 70 post-enrolment | Observed total oritavancin plasma concentrations measured at protocol-specified sampling time points to support development of the population pharmacokinetic model. |
| Secondary | Oritavancin dosing interval achieved in the therapeutic drug monitoring-guided cohort | From Day 1 to Day 70 post-enrolment | Time interval in days between consecutive oritavancin doses in participants managed using therapeutic drug monitoring-guided dosing. |
| Secondary | Number of participants with treatment-emergent adverse events in the oritavancin cohorts | From enrolment to Day 180 post-enrolment | Number of participants receiving oritavancin with at least 1 treatment-emergent adverse event. |
| Secondary | Number of participants with serious adverse events in the oritavancin cohorts | From enrolment to Day 180 post-enrolment | Number of participants receiving oritavancin with at least 1 serious adverse event. |
| Secondary | Number of participants with infusion-related reactions in the oritavancin cohorts | From enrolment to Day 180 post-enrolment | Number of participants receiving oritavancin with at least 1 infusion-related reaction. |
| Secondary | Change from Baseline to Day 70 in EuroQol 5-Dimension 5-Level Index Score | Baseline to Day 70 post-enrolment | Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L index score is derived from participant responses across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Using the Australian EQ-5D-5L value set, possible index scores range from -0.30 to 1.00, where 1.00 represents full health, 0 represents a health state equivalent to death, and scores below 0 represent health states valued worse than death. Higher scores indicate better health-related quality of life. Change will be calculated as the Day 70 score minus the baseline score; a positive change indicates improvement. |
| Secondary | Proportion of participants completing protocol-specified dosing and monitoring through Day 70 | From enrolment to Day 70 post-enrolment | Proportion of participants who complete the protocol-specified dosing schedule and planned therapeutic drug monitoring/sample collection through Day 70. |
| Secondary | Recruitment rate | From study opening to completion of enrolment | Proportion of eligible participants who are enrolled into the study. |
| Secondary | Retention rate at Day 70 | From enrolment to Day 70 post-enrolment | Proportion of enrolled participants who complete Day 70 follow-up. |
| Secondary | Number of participants who complete planned study treatment | By Day 70 post-enrolment | Number of participants who complete their planned study treatment course as determined by the treating clinician and protocol-defined study treatment period. |
| Secondary | Number of participants with clinical or microbiological failure | By Day 70 post-enrolment | Number of participants with clinical or microbiological failure, including worsening or recurrent signs of cardiac infection, need for change/addition of antibiotic therapy due to inadequate response, or relapse with the same organism following study treatment. |
| Secondary | Number of participants with hospital readmission by Day 70 | By Day 70 post-enrolment | Number of participants with at least 1 hospital readmission. |
| Secondary | Number of participants who die by Day 70 | By Day 70 post-enrolment | All-cause mortality. |
| Secondary | Number of participants with hospital readmission by Day 180 | By Day 180 post-enrolment | Number of participants with at least 1 hospital readmission. |
| Secondary | Number of participants who die by Day 180 | By Day 180 post-enrolment | All-cause mortality. |
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.
For software
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