Skin Diseases, BacterialPhase 4NCT02925416
Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
A Phase 4 study testing Oritavancin in people with Skin Diseases, Bacterial, run by The Medicines Company at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Bacterial
- What is being tested?
- Oritavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2017to 20 Jun 2017
- Phase
- Phase 4
- 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
- Diagnosis of ABSSSI (wound infections, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
- Able to give informed consent and willing to comply with all required study procedures
Who cannot join
- Infections associated with, or in close proximity to, a prosthetic device
- 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 (i.e., human or animal bites, injuries contaminated with fresh or salt water, external malignant otitis)
- Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens
Show all 26Show fewer
- Diabetic foot infections (infection extending distal to the malleoli in a participant with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or any ulceration of their foot)
- Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis)
- Infected burns
- A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema, or hidradenitis suppurativa
- Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
- Any evolving necrotizing process (i.e., necrotizing fasciitis), gangrene, or infection suspected or proven to be caused by Clostridium species (e.g., crepitance on examination of the ABSSSI site and/or surrounding tissue(s) or radiographic evidence of subcutaneous gas in proximity to the infection)
- Infections known to be caused by a Gram-positive organism with a vancomycin minimum inhibitory concentration (MIC) >2 μg/mL or clinically failing prior therapy with glycopeptides
- Catheter site infections
- Currently receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone (prednisone at non-immunosuppressive doses of ≤15 mg/day is permitted)
- Participants who are likely to need treatment with IV unfractionated heparin sodium within 48 hours after oritavancin administration
- Last known cluster of differentiation 4 (CD4) count <200 cells/mm^3 in participants with known human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
- Neutropenia with absolute neutrophil count (ANC) <500 cells/mm^3
- Significant or life-threatening condition (e.g., endocarditis) that would confound or interfere with the assessment of safety
- Women who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 acceptable methods of birth control: (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥2 years postmenopausal or surgically sterile are exempt from this exclusion
- History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or dalbavancin) or any of their excipients. Note: participants who have had histamine-like infusion reactions to a glycopeptide are not excluded
- Participants unwilling to forego blood and/or blood product donation for at least 1 month from initiation of oritavancin dose
- Treatment with investigational medicinal product within 30 days or 5 half-lives, whichever is longer, before enrollment and for the duration of the study
- Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection
- Participants who the investigator considers unlikely to adhere to the protocol, comply with oritavancin administration, or complete the clinical study (e.g., unlikely to survive 90 days from initiation of oritavancin dosing)
- Prior exposure to oritavancin alone or in combination with another product.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
About this study
Official title: A Double-Blind, Randomized Study to Evaluate the Safety of Either a Single 1200-mg Intravenous (IV) Dose of Orbactiv™ (Oritavancin) and Placebo or Two IV Doses of Orbactiv™ in Subjects Being Treated for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
The purpose of this study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart.
Read the detailed description
Clinical studies in adult participants with acute bacterial skin and skin structure infection (ABSSSI) have demonstrated that a single 1200-mg IV dose of oritavancin was clinically non-inferior, well tolerated, and had a similar safety profile to 7 to 10 days of IV vancomycin treatment. The 1200-mg dose of oritavancin is the United States approved therapeutic dose.
Participants with ABSSSI were enrolled in this study to obtain safety information of two 1200-mg IV infusions of oritavancin when administered one week apart.
- Conditions
- Skin Diseases, Bacterial
- Being tested
- Oritavancin, Placebo (D5W)
- Medical subject headings
- Skin Diseases, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OritavancinDrug
Also called Orbactiv
Administered intravenously
Placebo (D5W)Drug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin/Oritavancin | Experimental | On Day 1, participants were administered a single 1200-mg IV dose of oritavancin in 1000 milliliters (mL) diluted in 5% dextrose in water (D5W). On Day 7, an additional 1200-mg IV dose of oritavancin in 1000 mL of D5W was administered. Receives: Drug: Oritavancin |
| Oritavancin/Placebo | Other | On Day 1, participants were administered a single 1200-mg IV dose of oritavancin in 1000 mL of D5W. On Day 7, a placebo was administered IV in 1000 mL of D5W. Receives: Drug: Oritavancin; Drug: Placebo (D5W) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Treatment emergent adverse events (TEAE) were AEs which occurred or whose severities worsened on or after the initiation of study drug. 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.
Measured: Up to Day 21 after first administration of oritavancin
Secondary outcomes (1)
Number of Participants With a Clinical Response of Cure
Participants were classified by investigator assessment as "success" for clinical response of cure if there was a complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics was needed.
Measured: Up to Day 8 after first administration of oritavancin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start24 Jan 2017
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
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.
- Other trials for Skin Diseases, BacterialStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Information, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925416
- Sponsor's protocol ID
- MDCO-ORI-16-02
- Status last verified
- Jan 2024
- First submitted
- 4 Oct 2016
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Study to Evaluate the Safety of Either a Single 1200-mg Intravenous (IV) Dose of Orbactiv™ (Oritavancin) and Placebo or Two IV Doses of Orbactiv™ in Subjects Being Treated for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
- ClinicalTrials.gov ID
- NCT02925416
- Acronym / sponsor ID
- MDCO-ORI-16-02
- Conditions
- Skin Diseases, Bacterial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 1 Feb 2024
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 study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart.
Detailed description
Clinical studies in adult participants with acute bacterial skin and skin structure infection (ABSSSI) have demonstrated that a single 1200-mg IV dose of oritavancin was clinically non-inferior, well tolerated, and had a similar safety profile to 7 to 10 days of IV vancomycin treatment. The 1200-mg dose of oritavancin is the United States approved therapeutic dose.
Participants with ABSSSI were enrolled in this study to obtain safety information of two 1200-mg IV infusions of oritavancin when administered one week apart.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oritavancin/Oritavancin | Experimental | Drug: OritavancinOn Day 1, participants were administered a single 1200-mg IV dose of oritavancin in 1000 milliliters (mL) diluted in 5% dextrose in water (D5W). On Day 7, an additional 1200-mg IV dose of oritavancin in 1000 mL of D5W was administered. |
| Oritavancin/Placebo | Other | Drug: Oritavancin, Drug: Placebo (D5W)On Day 1, participants were administered a single 1200-mg IV dose of oritavancin in 1000 mL of D5W. On Day 7, a placebo was administered IV in 1000 mL of D5W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ABSSSI (wound infections, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
- Able to give informed consent and willing to comply with all required study procedures
Key exclusion criteria (26 listed)
- Infections associated with, or in close proximity to, a prosthetic device
- Severe sepsis or refractory shock
- Known or suspected bacteremia at time of screening
- ABSSSI due to or associated with any of the following:
- Currently receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone (prednisone at non-immunosuppressive doses of ≤15 mg/day is permitted)
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 |
|---|---|---|
| OritavancinAlso: OrbactivAdministered intravenously | Drug | Oritavancin/Oritavancin, Oritavancin/Placebo |
| Placebo (D5W)Administered intravenously | Drug | Oritavancin/Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 21 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. Treatment emergent adverse events (TEAE) were AEs which occurred or whose severities worsened on or after the initiation of study drug. 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.
1 secondary outcome
Number of Participants With a Clinical Response of Cure
Time frame: Up to Day 8 after first administration of oritavancin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Medical Information study director
Melinta Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oritavancin in people with Skin Diseases, Bacterial, run by The Medicines Company 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 2 inclusion and 26 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 Feb 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Feb 2024). 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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 21 after first administration of oritavancin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2024.