Trial Outcomes & Findings for Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (NCT NCT01252732)

Last Updated: 2021-05-05

Results Overview

Clinical response at the ECE visit (48-72 hours following initiation of study drug administration). Early clinical response was defined as a composite outcome based on, cessation of spreading or reduction in the size of baseline lesion, absence of fever and no rescue antibiotic medication.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1019 participants

Primary outcome timeframe

48-72 hours after the initation of study therapy

Results posted on

2021-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Single-Dose 1200 mg Oritavancin Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.	Vancomycin IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
Overall Study STARTED	509	510
Overall Study Modified Intent to Treat Population	503	502
Overall Study COMPLETED	455	446
Overall Study NOT COMPLETED	54	64

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-Dose 1200 mg Oritavancin n=503 Participants Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.	Vancomycin n=502 Participants IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.	Total n=1005 Participants Total of all reporting groups
Age, Continuous	45.0 years STANDARD_DEVIATION 13.40 • n=5 Participants	44.4 years STANDARD_DEVIATION 14.29 • n=7 Participants	44.7 years STANDARD_DEVIATION 13.85 • n=5 Participants
Sex: Female, Male Female	165 Participants n=5 Participants	159 Participants n=7 Participants	324 Participants n=5 Participants
Sex: Female, Male Male	338 Participants n=5 Participants	343 Participants n=7 Participants	681 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48-72 hours after the initation of study therapy

Population: Modified intent to treat (mITT) population consisting of all patients randomized into the trial and received any study drug.

Outcome measures

Outcome measures
Measure	Single-Dose 1200 mg Oritavancin n=503 Participants Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.	Vancomycin n=502 Participants IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
Early Clinical Response Success	403 participants	416 participants
Early Clinical Response Failure	100 participants	86 participants

SECONDARY outcome

Timeframe: 7 to 14 days after end of therapy

Population: Modified intent to treat (mITT) population consisting of all patients randomized into the trial and received any study drug.

Compared the clinical efficacy at the Post Therapy Evaluation of Oritavancin and Vancomycin based on the Investigator examination of the signs and symptoms of the primary ABSSSI; Investigator assessment of clinical cure is complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics is needed

Outcome measures

Outcome measures
Measure	Single-Dose 1200 mg Oritavancin n=503 Participants Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.	Vancomycin n=502 Participants IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
Investigator Assessed Clinical Cure at Post Therapy Evaluation (Key Secondary Endpoint) Clinical Cure	416 participants	404 participants
Investigator Assessed Clinical Cure at Post Therapy Evaluation (Key Secondary Endpoint) Clinical Failure	87 participants	98 participants

SECONDARY outcome

Timeframe: 48-72 hours after the initation of study therapy

Population: Modified intent to treat (mITT) population consisting of all patients randomized into the trial and received any study drug.

Clinical response at the ECE visit (48-72 hours following initiation of study drug administration) based on changes in ABSSSI lesion size measurements from baseline.

Outcome measures

Outcome measures
Measure	Single-Dose 1200 mg Oritavancin n=503 Participants Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.	Vancomycin n=502 Participants IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
>= 20% Reduction in Lesion Area Success	432 participants	428 participants
>= 20% Reduction in Lesion Area Failure	71 participants	74 participants

Adverse Events

Single-Dose 1200 mg Oritavancin

Serious events: 22 serious events

Other events: 272 other events

Deaths: 0 deaths

Vancomycin

Serious events: 23 serious events

Other events: 265 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Karen Fusaro

Melinta Therapeutics, Inc.

Phone: 6098270956

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Single-Dose 1200 mg Oritavancin n=503 participants at risk Single 1200 mg IV Dose of Oritavancin Diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days up to a maximum of 10 days.	Vancomycin n=502 participants at risk IV Vancomycin, 1g or 15mg/kg administered twice daily for a minimum of 7 days up to a maximum of 10 days.
Gastrointestinal disorders nausea	8.9% 45/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	12.0% 60/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Nervous system disorders headache	7.0% 35/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	5.6% 28/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Gastrointestinal disorders vomiting	4.4% 22/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	5.6% 28/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Infections and infestations cellulitis	3.4% 17/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	3.0% 15/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Investigations alanine aminotransferase increased	3.2% 16/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	2.0% 10/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
General disorders infusion site phlebitis	3.2% 16/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	1.00% 5/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
General disorders pyrexia	3.0% 15/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	2.2% 11/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
General disorders infusion site extravasation	3.0% 15/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	2.0% 10/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Cardiac disorders tachycardia	3.0% 15/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	1.4% 7/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Gastrointestinal disorders constipation	2.8% 14/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	3.4% 17/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Infections and infestations abscess limb	2.8% 14/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	1.6% 8/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Skin and subcutaneous tissue disorders pruritus	2.6% 13/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	5.8% 29/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Gastrointestinal disorders diarrhea	2.6% 13/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	3.0% 15/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Investigations aspartate aminotransferase increased	2.2% 11/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	2.2% 11/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.
Nervous system disorders dizziness	2.2% 11/503 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.	2.2% 11/502 • Begins from the time the patient provided informed consent through to the last follow up visit at 60 (+7) days. Additional Description Adverse events were analysed in the safety population consisting of all patients who received any study drug. The analysis was performed according to the actual treatment that the patient received.