Trial Outcomes & Findings for A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI) (NCT NCT02452918)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Up to 2 weeks after first administration of oritavancin

Results posted on

2023-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	Oritavancin 1200 mg Without Concomitant Warfarin Therapy Oritavancin as a single 1200 mg intravenous (IV) dose administered over 3 hours in participants with acute bacterial skin and skin structure infection (ABSSSI) who were not on concomitant warfarin therapy	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
Overall Study STARTED	15	2
Overall Study Received at Least 1 Dose of Study Drug	15	2
Overall Study COMPLETED	15	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oritavancin 1200 mg Without Concomitant Warfarin Therapy n=15 Participants Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy	Oritavancin 1200 mg With Concomitant Warfarin Therapy n=2 Participants Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	0 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	2 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks after first administration of oritavancin

Population: Safety analysis population included all participants who were dosed with IV 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.

Outcome measures

Outcome measures
Measure	Oritavancin 1200 mg Without Concomitant Warfarin Therapy n=15 Participants Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy	Oritavancin 1200 mg With Concomitant Warfarin Therapy n=2 Participants Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) At least 1 AE	2 Participants	1 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) At least 1 SAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Oritavancin 1200 mg Without Concomitant Warfarin Therapy n=15 Participants Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy	Oritavancin 1200 mg With Concomitant Warfarin Therapy n=2 Participants Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy
Number of Participants With a Clinical Response of Cure	15 Participants	2 Participants

Adverse Events

Oritavancin 1200 mg Without Concomitant Warfarin Therapy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Oritavancin 1200 mg With Concomitant Warfarin Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oritavancin 1200 mg Without Concomitant Warfarin Therapy n=15 participants at risk Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy	Oritavancin 1200 mg With Concomitant Warfarin Therapy n=2 participants at risk Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy
General disorders Infusion site phlebitis	6.7% 1/15 • Up to 2 weeks after first administration of oritavancin Safety analysis population included all participants who were dosed with IV oritavancin.	0.00% 0/2 • Up to 2 weeks after first administration of oritavancin Safety analysis population included all participants who were dosed with IV oritavancin.
Injury, poisoning and procedural complications Subcutaneous hematoma	6.7% 1/15 • Up to 2 weeks after first administration of oritavancin Safety analysis population included all participants who were dosed with IV oritavancin.	0.00% 0/2 • Up to 2 weeks after first administration of oritavancin Safety analysis population included all participants who were dosed with IV oritavancin.
Gastrointestinal disorders Nausea	0.00% 0/15 • Up to 2 weeks after first administration of oritavancin Safety analysis population included all participants who were dosed with IV oritavancin.	50.0% 1/2 • Up to 2 weeks after first administration of oritavancin Safety analysis population included all participants who were dosed with IV oritavancin.
General disorders Infusion site pain	0.00% 0/15 • Up to 2 weeks after first administration of oritavancin Safety analysis population included all participants who were dosed with IV oritavancin.	50.0% 1/2 • Up to 2 weeks after first administration of oritavancin Safety analysis population included all participants who were dosed with IV oritavancin.

Additional Information

Study Director

Melinta Therapeutics

Phone: 1-844-633-6568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER