Trial · NCT03873987
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
NCT03873987, Phase 1, Completed, Melinta Therapeutics, Inc.; results first posted 2021-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients. Trials, record NCT03873987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03873987
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
- NCT number
- NCT03873987
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 102 participants, actual
- Lead sponsor
- Melinta Therapeutics, Inc.
- Conditions
- Acute Bacterial Skin and Skin Structure Infection
- Interventions
- Current Formulation of Oritavancin, Kimyrsa
- First posted
- 2019-03-14
- Last updated
- 2021-04-13
- Results first posted
- 2021-04-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Exposure of AUC of the New Formulation to the Approved Formulation | 72 hours | Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 72 hr (AUC0-72) |
| Primary | Relative Exposure of AUC of the New Formulation to the Approved Formulation | 168 hours (Day 8) | Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 168 hr (AUC0-168). |
| Secondary | Number of Subjects With at Least One Treatment Emergent Adverse Event (TEAE) | 336 hours (Day 15) | Number of subjects with at least one treatment emergent adverse event (TEAE) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Exposure of AUC of the New Formulation to the Approved Formulation | 72 hours | PK Population: all subjects who have received the full dose of oritavancin and have any valid samples measured for study drug levels | h*µg/mL | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Relative Exposure of AUC of the New Formulation to the Approved Formulation | 168 hours (Day 8) | PK Population | h*µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With at Least One Treatment Emergent Adverse Event (TEAE) | 336 hours (Day 15) | Safety analysis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Exposure of AUC of the New Formulation to the Approved Formulation | Orbactiv | 1470 | Geometric Coefficient of Variation 39.7 | h*µg/mL | |
| Relative Exposure of AUC of the New Formulation to the Approved Formulation | Kimrysa | 1460 | Geometric Coefficient of Variation 35.1 | h*µg/mL | |
| Relative Exposure of AUC of the New Formulation to the Approved Formulation | Orbactiv | 1760 | Geometric Coefficient of Variation 41.4 | h*µg/mL | |
| Relative Exposure of AUC of the New Formulation to the Approved Formulation | Kimrysa | 1750 | Geometric Coefficient of Variation 35 | h*µg/mL | |
| Number of Subjects With at Least One Treatment Emergent Adverse Event (TEAE) | Orbactiv | 31 | Participants | ||
| Number of Subjects With at Least One Treatment Emergent Adverse Event (TEAE) | Kimyrsa | 24 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Current Formulation of Oritavancin | 52 | |
| Overall Study | STARTED | New Formulation of Oritavancin | 50 | |
| Overall Study | COMPLETED | Current Formulation of Oritavancin | 50 | |
| Overall Study | COMPLETED | New Formulation of Oritavancin | 49 | |
| Overall Study | NOT COMPLETED | Current Formulation of Oritavancin | 2 | |
| Overall Study | NOT COMPLETED | New Formulation of Oritavancin | 1 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypersensitivity | Immune system disorders | Orbactiv | 2 | 52 | |
| other | Hypersensitivity | Immune system disorders | Kimrysa | 1 | 50 | |
| other | Abscess | Infections and infestations | Orbactiv | 1 | 52 | |
| other | Abscess | Infections and infestations | Kimrysa | 0 | 50 | |
| other | Infection | Infections and infestations | Orbactiv | 3 | 52 | |
| other | Infection | Infections and infestations | Kimrysa | 2 | 50 | |
| other | Oral candidiasis | Infections and infestations | Orbactiv | 0 | 52 | |
| other | Oral candidiasis | Infections and infestations | Kimrysa | 1 | 50 | |
| other | Skin infection | Infections and infestations | Orbactiv | 2 | 52 | |
| other | Skin infection | Infections and infestations | Kimrysa | 0 | 50 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Orbactiv | 0 | 52 |
| Total, all-cause mortality | Kimrysa | 0 | 50 |
| Total, other adverse events | Orbactiv | 31 | 52 |
| Total, other adverse events | Kimrysa | 24 | 50 |
| Total, serious adverse events | Orbactiv | 1 | 52 |
| Total, serious adverse events | Kimrysa | 2 | 50 |
Source ClinicalTrials.gov
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Orbactiv vs Kimrysa: deaths from any cause | Trial comparisons |
| Orbactiv vs Kimyrsa: Number of Subjects With at Least One Treatment Emergent Adverse Event (TEAE) | Trial comparisons |
| Orbactiv vs Kimrysa: serious adverse events | Trial comparisons |
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/NCT03873987
GET https://conductscience.org/api/trials/v1/NCT03873987/events?page=2