Wound InfectionPhase 3SOLO INCT01252719
Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
A Phase 3 study testing Single-Dose IV Oritavancin Diphosphate and IV Vancomycin in people with Wound Infection and Abscess, run by Melinta Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection, Abscess, Systemic Inflammation
- What is being tested?
- Single-Dose IV Oritavancin Diphosphate and IV Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 968 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 30 Nov 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were included in the study if they met all of the following inclusion criteria:
- Males or females ≥18 years old
- Diagnosis of ABSSSI suspected or confirmed to be caused by a gram-positive pathogen requiring at least 7 days of IV therapy
- An ABSSSI included 1 of the following infections: wound infections, cellulitis/erysipelas, major cutaneous abscess
- ABSSSI must have presented with at least 2 local signs and symptoms and at least 1 sign of systemic inflammation (unless >70 years of age).
- Able to give informed consent and willing to comply with all required study procedures
Who cannot join
- Participants were excluded from the study if any of the following exclusion criteria applied prior to randomization:
- Prior systemic or topical antibacterial therapy with activity against suspected or proven gram-positive pathogens within the preceding 14 days unless:
- The causative gram-positive pathogen(s) isolated from the ABSSSI site was/were resistant in vitro to the antibacterial(s) that was/were administered with documented clinical progression.
- Documented failure to previous ABSSSI antibiotic therapy was available. Documentation of treatment failure must have been recorded.
- Participant received a single dose of a short-acting antibacterial therapy 3 or more days before randomization.
- Infections associated with, or in close proximity to, a prosthetic device
Show all 35Show fewer
- Severe sepsis or refractory shock
- Known or suspected bacteremia at time of Screening
- ABSSSI due to or associated with any of the following:
- Infections suspected or documented to be caused by gram-negative pathogens
- Wound infections (surgical or traumatic) and abscesses with only gram-negative pathogens
- Diabetic foot infections
- Concomitant infection at another site not including a secondary ABSSSI lesion
- Infected burns
- A primary infection secondary to a pre-existing skin disease with associated inflammatory changes
- Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease
- Any evolving necrotizing process gangrene or infection suspected or proven to be caused by Clostridium species
- Infections known to be caused by a gram-positive organism with a vancomycin minimum inhibitory concentration >2 micrograms/milliliter or clinically failing prior therapy with glycopeptides
- Catheter site infections
- Allergy or intolerance to aztreonam or metronidazole in a participant with suspected or proven polymicrobial wound infection involving gram-negative and/or anaerobic bacteria
- Was currently receiving chronic systemic immunosuppressive therapy
- Acquired immunodeficiency syndrome with cluster of differentiation 4 count <200 cells/cubic millimeter
- Neutropenia
- Significant or life-threatening condition that would confound or interfere with the assessment of the ABSSSI
- Women who were pregnant or nursing
- History of immune-related hypersensitivity reaction to glycopeptides
- Participants that required anticoagulant monitoring with an activated partial thromboplastin time
- Contraindication to vancomycin
- Participants unwilling to forego blood and/or blood product donation
- Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
- Investigational device present, or removed <30 days before enrollment, or presence of device-related infection
- Participants unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study
- Severe hepatic disease
- Presence of hyperuricemia
- Unwilling to refrain from chronic use of any medication with antipyretic properties
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Chula Vista Medical Center
Chula Vista, California, 91911
About this study
Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.
Read the detailed description
This was a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with ABSSSI suspected or proven to be caused by gram-positive pathogens. Approximately 960 participants were to be randomized at 100 centers globally.
In addition, this study characterized the pharmacokinetics (PK) and PK/pharmacodynamics (PD) properties of a single 1200-mg IV dose of oritavancin and evaluated the potential health economic benefits offered by this dosing strategy.
- Conditions
- Wound Infection, Abscess, Systemic Inflammation, Cellulitis
- Being tested
- Single-Dose IV Oritavancin Diphosphate, IV Vancomycin, Placebo
- Keywords
- ABSSSI, Skin Infection, Abscess
- Medical subject headings
- Wound Infection, Abscess, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Dose IV Oritavancin DiphosphateDrug
Oritavancin was administered as a single IV dose.
IV VancomycinDrug
Intravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days.
PlaceboDrug
Intravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo).
| Study group | Role | What they receive |
|---|---|---|
| Single-Dose IV Oritavancin Diphosphate | Experimental | Not described Receives: Drug: Single-Dose IV Oritavancin Diphosphate; Drug: Placebo |
| IV Vancomycin | Active comparator | Not described Receives: Drug: IV Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 48-72 hours after the initiation of study therapy
Secondary outcomes (2)
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)
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.
Measured: 7-14 days after end of therapy
Number Of Participants With A Lesion Size Reduction ≥20% From Baseline At ECE
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'.
Measured: 48-72 hours after the initiation of study therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2012
- Study completion30 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- G. Ralph Corey, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252719
- Sponsor's protocol ID
- TMC-ORI-10-01
- Acronym
- SOLO I
- Status last verified
- Jul 2022
- First submitted
- 1 Dec 2010
- Last updated
- 1 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Corey GR, Loutit J, Moeck G, Wikler M, Dudley MN, O'Riordan W; SOLO I and SOLO II investigators. Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e01919-17. doi: 10.1128/AAC.01919-17. Print 2018 Apr.
PubMed 29358292Deck DH, Jordan JM, Holland TL, Fan W, Wikler MA, Sulham KA, Ralph Corey G. Single-Dose Oritavancin Treatment of Acute Bacterial Skin and Skin Structure Infections: SOLO Trial Efficacy by Eron Severity and Management Setting. Infect Dis Ther. 2016 Sep;5(3):353-61. doi: 10.1007/s40121-016-0119-9. Epub 2016 Jul 1.
PubMed 27370913Corey GR, Kabler H, Mehra P, Gupta S, Overcash JS, Porwal A, Giordano P, Lucasti C, Perez A, Good S, Jiang H, Moeck G, O'Riordan W; SOLO I Investigators. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014 Jun 5;370(23):2180-90. doi: 10.1056/NEJMoa1310422.
PubMed 24897083
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
- ClinicalTrials.gov ID
- NCT01252719
- Acronym / sponsor ID
- SOLO I / TMC-ORI-10-01
- Conditions
- Wound Infection, Abscess, Systemic Inflammation, Cellulitis
- Keywords
- ABSSSI, Skin Infection, Abscess
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- 30 Nov 2012 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 1 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.
Detailed description
This was a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with ABSSSI suspected or proven to be caused by gram-positive pathogens. Approximately 960 participants were to be randomized at 100 centers globally.
In addition, this study characterized the pharmacokinetics (PK) and PK/pharmacodynamics (PD) properties of a single 1200-mg IV dose of oritavancin and evaluated the potential health economic benefits offered by this dosing strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Dose IV Oritavancin Diphosphate | Experimental | Drug: Single-Dose IV Oritavancin Diphosphate, Drug: Placebo |
| IV Vancomycin | Active comparator | Drug: IV Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants were included in the study if they met all of the following inclusion criteria:
- Males or females ≥18 years old
- Diagnosis of ABSSSI suspected or confirmed to be caused by a gram-positive pathogen requiring at least 7 days of IV therapy
- An ABSSSI included 1 of the following infections: wound infections, cellulitis/erysipelas, major cutaneous abscess
- ABSSSI must have presented with at least 2 local signs and symptoms and at least 1 sign of systemic inflammation (unless >70 years of age).
Key exclusion criteria (35 listed)
- Participants were excluded from the study if any of the following exclusion criteria applied prior to randomization:
- Prior systemic or topical antibacterial therapy with activity against suspected or proven gram-positive pathogens within the preceding 14 days unless:
- Infections associated with, or in close proximity to, a prosthetic device
- Severe sepsis or refractory shock
- Known or suspected bacteremia at time of Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Dose IV Oritavancin DiphosphateOritavancin was administered as a single IV dose. | Drug | Single-Dose IV Oritavancin Diphosphate |
| IV VancomycinIntravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days. | Drug | IV Vancomycin |
| PlaceboIntravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo). | Drug | Single-Dose IV Oritavancin Diphosphate |
Primary outcome
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)
Time frame: 48-72 hours after the initiation of study therapy
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.
2 secondary outcomes
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)
Time frame: 7-14 days after end of therapy
Number Of Participants With A Lesion Size Reduction ≥20% From Baseline At ECE
Time frame: 48-72 hours after the initiation of study therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29358292Corey GR, Loutit J, Moeck G, Wikler M, Dudley MN, O'Riordan W; SOLO I and SOLO II investigators. Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e01919-17. doi: 10.1128/AAC.01919-17. Print 2018 Apr.
- Derived from this study: PubMed 27370913Deck DH, Jordan JM, Holland TL, Fan W, Wikler MA, Sulham KA, Ralph Corey G. Single-Dose Oritavancin Treatment of Acute Bacterial Skin and Skin Structure Infections: SOLO Trial Efficacy by Eron Severity and Management Setting. Infect Dis Ther. 2016 Sep;5(3):353-61. doi: 10.1007/s40121-016-0119-9. Epub 2016 Jul 1.
- Derived from this study: PubMed 24897083Corey GR, Kabler H, Mehra P, Gupta S, Overcash JS, Porwal A, Giordano P, Lucasti C, Perez A, Good S, Jiang H, Moeck G, O'Riordan W; SOLO I Investigators. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014 Jun 5;370(23):2180-90. doi: 10.1056/NEJMoa1310422.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Ralph Corey, MD principal investigator
Duke Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single-Dose IV Oritavancin Diphosphate and IV Vancomycin in people with Wound Infection and Abscess, run by Melinta Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 48-72 hours after the initiation of study therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01252719, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.