Acute Bacterial Skin and Skin Structure InfectionPhase 4NCT02452918
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)
A Phase 4 study testing Oritavancin and Warfarin in people with Acute Bacterial Skin and Skin Structure Infection, run by The Medicines Company at 1 site in United States.
Trial summary
This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bacterial Skin and Skin Structure Infection
- What is being tested?
- Oritavancin and Warfarin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2015to 5 Jul 2016
- 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 infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
- Must be currently being treated with chronic warfarin therapy* *Participants in the non-warfarin group are not required to be on chronic warfarin therapy.
Who cannot join
- Known or suspected bacteremia, sepsis or refractory shock
- Participants who are likely to need treatment with IV heparin within 48 hours
- Significant or life-threatening condition
- Women who are pregnant or nursing
- Receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone
- CD4 count <200 cells/mm^3 in participants with known human immunodeficiency virus or acquired immune deficiency syndrome
- Neutropenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Evaluate the Safety of a Single 1200 mg IV Dose of Orbactiv (Oritavancin) in Subjects on Concomitant Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens.
An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.
- Being tested
- Oritavancin, Warfarin
- Keywords
- skin infection
- Medical subject headings
- Cellulitis
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
WarfarinDrug
Administered as a concomitant medication at a standard dose and dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin 1200 mg Without Concomitant Warfarin Therapy | Experimental | Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy Receives: Drug: Oritavancin |
| Oritavancin 1200 mg With Concomitant Warfarin Therapy | Experimental | Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy at a standard dose and dosing schedule Receives: Drug: Oritavancin; Drug: Warfarin |
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. 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 2 weeks 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 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.
Measured: At 48 to 72 hours after start of oritavancin dose and at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study start29 Sep 2015
- Primary completion5 Jul 2016
- Study completion5 Jul 2016
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 Acute Bacterial Skin and Skin Structure 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT02452918
- Sponsor's protocol ID
- MDCO-ORI-14-03
- Status last verified
- Dec 2023
- First submitted
- 13 May 2015
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety of a Single 1200 mg IV Dose of Orbactiv (Oritavancin) in Subjects on Concomitant Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
- ClinicalTrials.gov ID
- NCT02452918
- Acronym / sponsor ID
- MDCO-ORI-14-03
- Keywords
- skin infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2015 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 5 Jul 2016 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens.
An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oritavancin 1200 mg Without Concomitant Warfarin Therapy | Experimental | Drug: OritavancinOritavancin 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 | Experimental | Drug: Oritavancin, Drug: WarfarinOritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy at a standard dose and dosing schedule |
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 infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
- Must be currently being treated with chronic warfarin therapy* *Participants in the non-warfarin group are not required to be on chronic warfarin therapy.
Key exclusion criteria (7 listed)
- Known or suspected bacteremia, sepsis or refractory shock
- Participants who are likely to need treatment with IV heparin within 48 hours
- Significant or life-threatening condition
- Women who are pregnant or nursing
- Receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone
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 1200 mg With Concomitant Warfarin Therapy, Oritavancin 1200 mg Without Concomitant Warfarin Therapy |
| WarfarinAdministered as a concomitant medication at a standard dose and dosing schedule | Drug | Oritavancin 1200 mg With Concomitant Warfarin Therapy |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2 weeks 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. 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: At 48 to 72 hours after start of oritavancin dose and at Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 and Warfarin in people with Acute Bacterial Skin and Skin Structure Infection, 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 7 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 20 Dec 2023. 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 20 Dec 2023). 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 2 weeks 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 20 Dec 2023.