Trial Outcomes & Findings for Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I) (NCT NCT01252719)

Last Updated: 2022-08-01

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. A participant was classified as "success" if all of the following were met: cessation of spread or reduction of the lesion (defined as cessation of spread of the redness, edema, and/or induration or reduction in size \[length, width, and area\] of the redness, edema, and/or induration such that the size of the lesion was less than or equal to the size at baseline); resolution (absence) of fever (temperature \<37.7°Celsius at the last 3 consecutive recordings by the same route of administration taken 4 times per day, for example every 6 hours between 48 and 72 hours); no rescue antibiotic medication.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

968 participants

Primary outcome timeframe

48-72 hours after the initiation of study therapy

Results posted on

2022-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Single-Dose 1200 mg Oritavancin Single 1200 milligram (mg) intravenous (IV) dose of oritavancin diphosphate administered as first infusion followed by IV placebo administered twice daily for a minimum of 7 days and up to a maximum of 10 days.	Vancomycin Intravenous vancomycin, 1 gram (g) or 15 mg/kilogram (kg), administered twice daily for a minimum of 7 days and up to a maximum of 10 days.
Overall Study STARTED	483	485
Overall Study Modified Intent to Treat Population	475	479
Overall Study COMPLETED	433	423
Overall Study NOT COMPLETED	50	62

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-Dose 1200 mg Oritavancin n=475 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 and up to a maximum of 10 days.	Vancomycin n=479 Participants Intravenous vancomycin, 1 g or 15 mg/kg, administered twice daily for a minimum of 7 days and up to a maximum of 10 days.	Total n=954 Participants Total of all reporting groups
Age, Continuous	46.2 years STANDARD_DEVIATION 14.20 • n=5 Participants	44.3 years STANDARD_DEVIATION 14.50 • n=7 Participants	45.2 years STANDARD_DEVIATION 14.38 • n=5 Participants
Sex: Female, Male Female	174 Participants n=5 Participants	178 Participants n=7 Participants	352 Participants n=5 Participants
Sex: Female, Male Male	301 Participants n=5 Participants	301 Participants n=7 Participants	602 Participants n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Single-Dose 1200 mg Oritavancin n=475 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 and up to a maximum of 10 days.	Vancomycin n=479 Participants Intravenous vancomycin, 1 g or 15 mg/kg, administered twice daily for a minimum of 7 days and up to a maximum of 10 days.
Cessation Of Spread Or Reduction In Size Of Baseline Lesion, Absence Of Fever, And No Rescue Antibiotic Medication At Early Clinical Evaluation (ECE) (48 To 72 Hours) Success	391 participants	378 participants
Cessation Of Spread Or Reduction In Size Of Baseline Lesion, Absence Of Fever, And No Rescue Antibiotic Medication At Early Clinical Evaluation (ECE) (48 To 72 Hours) Failure	84 participants	101 participants

SECONDARY outcome

Timeframe: 7-14 days after end of therapy

Population: Modified intent to treat (mITT) population consisting of all participants who were 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 acute bacterial skin and skin structure infection (ABSSSI). Investigator assessment of clinical cure was 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	Single-Dose 1200 mg Oritavancin n=475 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 and up to a maximum of 10 days.	Vancomycin n=479 Participants Intravenous vancomycin, 1 g or 15 mg/kg, administered twice daily for a minimum of 7 days and up to a maximum of 10 days.
Investigator Assessed Clinical Cure Of Treatment With Single-dose IV Oritavancin Compared With IV Vancomycin For 7 To 10 Days At Post-therapy Evaluation (Key Secondary Endpoint) Clinical Cure	378 participants	383 participants
Investigator Assessed Clinical Cure Of Treatment With Single-dose IV Oritavancin Compared With IV Vancomycin For 7 To 10 Days At Post-therapy Evaluation (Key Secondary Endpoint) Clinical Failure	97 participants	96 participants

SECONDARY outcome

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

Population: Modified intent to treat (mITT) population consisting of all participants who were 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. Participants with a ≥20% reduction in size of baseline lesion were classified a 'success', while those with missing data or those without a reduction in size of baseline lesion ≥20% were classified a 'failure'.

Outcome measures

Outcome measures
Measure	Single-Dose 1200 mg Oritavancin n=475 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 and up to a maximum of 10 days.	Vancomycin n=479 Participants Intravenous vancomycin, 1 g or 15 mg/kg, administered twice daily for a minimum of 7 days and up to a maximum of 10 days.
Number Of Participants With A Lesion Size Reduction ≥20% From Baseline At ECE Success	413 Participants	397 Participants
Number Of Participants With A Lesion Size Reduction ≥20% From Baseline At ECE Failure	62 Participants	82 Participants

Adverse Events

Single-Dose 1200 mg Oritavancin

Serious events: 35 serious events

Other events: 323 other events

Deaths: 1 deaths

Vancomycin

Serious events: 35 serious events

Other events: 340 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Information

Melinta Therapeutics, LLC

Phone: 1-844-633-6568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Institution and PI agree that the Sponsor shall have the right to the first publication of the Study results. The Pl may publish data or results from the Study; provided, however, that the Institution and/or PI submits the proposed publication to Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary.
Publication restrictions are in place

Restriction type: OTHER

Measure	Single-Dose 1200 mg Oritavancin n=473 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 and up to a maximum of 10 days.	Vancomycin n=481 participants at risk Intravenous vancomycin, 1 g or 15 mg/kg, administered twice daily for a minimum of 7 days and up to a maximum of 10 days.
Gastrointestinal disorders Nausea	11.0% 52/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	8.9% 43/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Gastrointestinal disorders Vomiting	4.9% 23/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	3.7% 18/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Nervous system disorders Headache	7.2% 34/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	7.9% 38/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Gastrointestinal disorders Diarrhea	4.9% 23/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	3.5% 17/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Infections and infestations Cellulitis	4.2% 20/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	3.5% 17/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
General disorders Infusion site reaction	4.0% 19/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	7.1% 34/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Gastrointestinal disorders Constipation	4.0% 19/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	4.4% 21/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
General disorders Infusion site extravasation	3.8% 18/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	4.8% 23/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Skin and subcutaneous tissue disorders Pruritus	3.4% 16/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	9.1% 44/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
General disorders Pyrexia	3.2% 15/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	4.2% 20/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Nervous system disorders Dizziness	3.2% 15/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	3.1% 15/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Psychiatric disorders Insomnia	3.0% 14/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	2.7% 13/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Infections and infestations Abscess limb	2.7% 13/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	1.0% 5/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Skin and subcutaneous tissue disorders Pruritus generalized	2.3% 11/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	1.9% 9/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
Investigations Alanine aminotransferase increased	2.3% 11/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	1.0% 5/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
General disorders Chills	2.1% 10/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	2.5% 12/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.
General disorders Fatigue	2.1% 10/473 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.	1.2% 6/481 • Begins from the time the participant provided informed consent through to the last follow-up visit at 60 (+7) days. Adverse events were analyzed in the safety population consisting of all participants who received any study drug. The analysis was performed according to the actual treatment that the participant received.