Acute Bacterial Skin and Skin Structure Infection
Conditions
Keywords
skin infection
Brief summary
This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.
Interventions
DRUGOritavancin
Administered intravenously
DRUGWarfarin
Administered as a concomitant medication at a standard dose and dosing schedule
Sponsors
The Medicines Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ABSSSI (wound infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy * Must be currently being treated with chronic warfarin therapy\* \*Participants in the non-warfarin group are not required to be on chronic warfarin therapy.
Exclusion criteria
* Known or suspected bacteremia, sepsis or refractory shock * Participants who are likely to need treatment with IV heparin within 48 hours * Significant or life-threatening condition * Women who are pregnant or nursing * Receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone * CD4 count \<200 cells/mm\^3 in participants with known human immunodeficiency virus or acquired immune deficiency syndrome * Neutropenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 2 weeks after first administration of oritavancin | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Clinical Response of Cure | At 48 to 72 hours after start of oritavancin dose and at Day 7 | Participants were classified by investigator assessment as success for clinical response of cure if all of the following were met: cessation of spread or reduction of the lesion; resolution (absence) of fever (temperature less than 37.7° Celsius); no rescue antibiotic medication; complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics was needed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oritavancin 1200 mg Without Concomitant Warfarin Therapy Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy | 15 |
| Oritavancin 1200 mg With Concomitant Warfarin Therapy Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy | 2 |
| Total | 17 |
Baseline characteristics
| Characteristic | Oritavancin 1200 mg With Concomitant Warfarin Therapy | Oritavancin 1200 mg Without Concomitant Warfarin Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 14 Participants | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 14 Participants | 16 Participants |
| Sex: Female, Male Female | 1 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 2 |
| other Total, other adverse events | 2 / 15 | 1 / 2 |
| serious Total, serious adverse events | 0 / 15 | 0 / 2 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Up to 2 weeks after first administration of oritavancin
Population: Safety analysis population included all participants who were dosed with IV oritavancin
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oritavancin 1200 mg Without Concomitant Warfarin Therapy | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | At least 1 AE | 2 Participants |
| Oritavancin 1200 mg Without Concomitant Warfarin Therapy | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | At least 1 SAE | 0 Participants |
| Oritavancin 1200 mg With Concomitant Warfarin Therapy | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | At least 1 AE | 1 Participants |
| Oritavancin 1200 mg With Concomitant Warfarin Therapy | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | At least 1 SAE | 0 Participants |
Secondary
Number of Participants With a Clinical Response of Cure
Participants were classified by investigator assessment as success for clinical response of cure if all of the following were met: cessation of spread or reduction of the lesion; resolution (absence) of fever (temperature less than 37.7° Celsius); no rescue antibiotic medication; complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics was needed.
Time frame: At 48 to 72 hours after start of oritavancin dose and at Day 7
Population: Safety analysis population included all participants who were dosed with IV oritavancin
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oritavancin 1200 mg Without Concomitant Warfarin Therapy | Number of Participants With a Clinical Response of Cure | 15 Participants |
| Oritavancin 1200 mg With Concomitant Warfarin Therapy | Number of Participants With a Clinical Response of Cure | 2 Participants |