Trial · NCT07550595
Oritavancin for Treatment of Serious Cardiac Infections
NCT07550595, Phase 2, Not yet recruiting, Kirby Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oritavancin for Treatment of Serious Cardiac Infections. Trials, record NCT07550595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07550595
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oritavancin for Treatment of Serious Cardiac Infections
- NCT number
- NCT07550595
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Kirby Institute
- Conditions
- Infective Endocarditis, Cardiac Device Infection, Gram-positive Bacterial Infections
- Interventions
- Oritavancin, Oritavancin
- First posted
- 2026-04-24
- Last updated
- 2026-04-29
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/NCT07550595
GET https://conductscience.org/api/trials/v1/NCT07550595/registered