Gram-Positive Bacterial InfectionsNCT03159403
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Orbactiv® (Oritavancin) for Infections Caused by Gram Positive Bacteria in a Real World Setting
An observational study of Gram-Positive Bacterial Infections, run by Melinta Therapeutics, Inc. at 21 sites in United States.
Trial summary
This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gram-Positive Bacterial Infections
- What is being tested?
- Oritavancin
- Type of treatment
- Injection or infusion
- How many people
- 325 participants
- Where
- 21 sitesUnited States
- Study dates
- 12 Apr 2017to 8 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants in real world settings (which include infusion centers, clinics, emergency departments, and observation and inpatient hospital beds), who received at least one dose of oritavancin.
Who may be able to join
- The participant was treated with at least one dose of oritavancin for a suspected or confirmed gram positive infection, as monotherapy or part of a broader regimen.
- At least 60 days has elapsed since the participant received the last dose of oritavancin therapy (prior to data entry into the electronic Case Report Form).
Who cannot join
- The participant received oritavancin as a part of a controlled clinical trial.
- The participant received oritavancin as a part of a Medicines Company-sponsored single or multi-centered pharmacoeconomic outcomes study.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Birmingham Infectious Disease and Infusion
Birmingham, Alabama, 35243
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Erie County Medical Center
Buffalo, New York, 14215
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
TruCare Internal Medicine and Infectious Diseases
DuBois, Pennsylvania, 15801
Center for Infectious Diseases & Travel Medicine
El Paso, Texas, 79902
Florida Infectious Disease Care
Fort Myers, Florida, 33912
Snake River Research, PLLC
Idaho Falls, Idaho, 83404
St. Vincent Hospital and Health Care Center, Inc.
Indianapolis, Indiana, 46260
Clinical Infectious Disease Specialists
Las Vegas, Nevada, 89128
WellStar Health System - Kennestone
Marietta, Georgia, 30060
Trinity Health Medical Group
Minot, North Dakota, 58701
Infectious Diseases Associates of North Central Florida, LLC
Ocala, Florida, 34471
Infectious Diseases Consultants of OKC
Oklahoma City, Oklahoma, 73109
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Foot & Ankle Institute
St. George, Utah, 84770
Houston Center For Infectious Diseases
The Woodlands, Texas, 77380
Infectious Disease and Pulmonary
Victoria, Texas, 77901
IDC Clinical Research, LLC
Wichita, Kansas, 67214
About this study
Official title: Retrospective, Observational Evaluation of the Utilization, Outcomes, and Adverse Events Associated With Orbactiv® for the Treatment of Infections Presumed or Confirmed to be Caused by Gram Positive Bacteria in a Real World Setting
This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.
- Conditions
- Gram-Positive Bacterial Infections
- Being tested
- Oritavancin
- Medical subject headings
- Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OritavancinDrug
Also called Orbactiv®
This study is an observational study. All participants were administered oritavancin prior to enrollment in this study.
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin | Participants who received at least one dose (at least one for 3 hours per dose) of oritavancin intravenous (IV) as monotherapy or part of a broader regimen. The maximum number of doses to be received by a participant is not known at this time. Receives: Drug: Oritavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types Of Primary Infections Being Treated With Oritavancin
The Types Of Primary Infections refers to whether the primary infection was skin or skin structure or other systemic infection (for example, bacteremia, prosthetic joint infection, osteomyelitis).
Measured: Day 1
Classification Of Primary Infections Being Treated With Oritavancin
The classification of primary infection refers to whether a skin or skin structure infection was cellulitis, abscess, wound, or other.
Measured: Day 1
Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site
All microbiology results during the infection event will be reported. Microbiology results will be noted only for the infection site for which oritavancin (in addition to other agents) is administered or other site related to the primary infection in case of multiple infections. An adverse event was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
Measured: Up to 30 days after oritavancin IV infusion
Duration Of Treatment With Oritavancin
The number of days of treatment with oritavancin will be presented.
Measured: Day 1 through end of oritavancin IV infusion
Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure
Clinical assessments will be based on participant records between end of infusion to 30 days following the last dose of Oritavancin. Clinical categories for assessment include:
- Cure - Clinical signs and symptoms are resolved, and no additional antibiotic therapy is necessary for the treatment of the infection
- Improved - Partial resolution of clinical signs and symptoms, and no additional antibiotic therapy is necessary for the treatment of the infection
- Failure - Inadequate resolution, or new or worsening clinical signs and symptoms, such that additional antibiotic therapy is necessary for treatment of the infection
- Non-evaluable - Unable to determine response because the participant record did not contain the necessary information to determine cure, improvement, or failure
Measured: Up to 30 days after oritavancin IV infusion
Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence
Microbiological assessments will be based on participant records between end of infusion to 30 days following the last dose of oritavancin. Microbiological categories will include only gram positive pathogens believed to be related to the infection process and are defined as:
- Microbiologic eradication (the baseline gram positive pathogen has been eradicated)
- Microbiologic persistence (the baseline gram positive pathogen persists)
- Culture drawn post-oritavancin therapy, but no information regarding microbiologic culture results
- No culture collected following the last dose of oritavancin
- No information available
Measured: Up to 30 days after oritavancin IV infusion
Use Of Concomitant Antibiotics With Oritavancin
Concomitant antibiotics include those used between the first and last dose of oritavancin. The number of participants and the type of antibiotic taken will be presented.
Measured: Day 1 through end of oritavancin IV infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start12 Apr 2017
- Primary completion15 Feb 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Positive Bacterial InfectionsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Information, Study director, Global Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159403
- Sponsor's protocol ID
- MDCO-ORI-15-05
- Status last verified
- Mar 2018
- First submitted
- 16 May 2017
- Last updated
- 12 Mar 2018
- Results posted
- No
- 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 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Observational Evaluation of the Utilization, Outcomes, and Adverse Events Associated With Orbactiv® for the Treatment of Infections Presumed or Confirmed to be Caused by Gram Positive Bacteria in a Real World Setting
- ClinicalTrials.gov ID
- NCT03159403
- Acronym / sponsor ID
- MDCO-ORI-15-05
- Conditions
- Gram-Positive Bacterial Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oritavancin | – | Drug: OritavancinParticipants who received at least one dose (at least one for 3 hours per dose) of oritavancin intravenous (IV) as monotherapy or part of a broader regimen. The maximum number of doses to be received by a participant is not known at this time. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in real world settings (which include infusion centers, clinics, emergency departments, and observation and inpatient hospital beds), who received at least one dose of oritavancin.
Key inclusion criteria (2 listed)
- The participant was treated with at least one dose of oritavancin for a suspected or confirmed gram positive infection, as monotherapy or part of a broader regimen.
- At least 60 days has elapsed since the participant received the last dose of oritavancin therapy (prior to data entry into the electronic Case Report Form).
Key exclusion criteria (2 listed)
- The participant received oritavancin as a part of a controlled clinical trial.
- The participant received oritavancin as a part of a Medicines Company-sponsored single or multi-centered pharmacoeconomic outcomes study.
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: Orbactiv®This study is an observational study. All participants were administered oritavancin prior to enrollment in this study. | Drug | Oritavancin |
Primary outcome
Types Of Primary Infections Being Treated With Oritavancin
Time frame: Day 1
The Types Of Primary Infections refers to whether the primary infection was skin or skin structure or other systemic infection (for example, bacteremia, prosthetic joint infection, osteomyelitis).
Classification Of Primary Infections Being Treated With Oritavancin
Time frame: Day 1
The classification of primary infection refers to whether a skin or skin structure infection was cellulitis, abscess, wound, or other.
Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site
Time frame: Up to 30 days after oritavancin IV infusion
All microbiology results during the infection event will be reported. Microbiology results will be noted only for the infection site for which oritavancin (in addition to other agents) is administered or other site related to the primary infection in case of multiple infections. An adverse event was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
Duration Of Treatment With Oritavancin
Time frame: Day 1 through end of oritavancin IV infusion
The number of days of treatment with oritavancin will be presented.
Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure
Time frame: Up to 30 days after oritavancin IV infusion
Clinical assessments will be based on participant records between end of infusion to 30 days following the last dose of Oritavancin. Clinical categories for assessment include: * Cure - Clinical signs and symptoms are resolved, and no additional antibiotic therapy is necessary for the treatment of the infection * Improved - Partial resolution of clinical signs and symptoms, and no additional antibiotic therapy is necessary for the treatment of the infection * Failure - Inadequate resolution, or new or worsening clinical signs and symptoms, such that additional antibiotic therapy is necessary for treatment of the infection * Non-evaluable - Unable to determine response because the participant record did not contain the necessary information to determine cure, improvement, or failure
Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence
Time frame: Up to 30 days after oritavancin IV infusion
Microbiological assessments will be based on participant records between end of infusion to 30 days following the last dose of oritavancin. Microbiological categories will include only gram positive pathogens believed to be related to the infection process and are defined as: * Microbiologic eradication (the baseline gram positive pathogen has been eradicated) * Microbiologic persistence (the baseline gram positive pathogen persists) * Culture drawn post-oritavancin therapy, but no information regarding microbiologic culture results * No culture collected following the last dose of oritavancin * No information available
Use Of Concomitant Antibiotics With Oritavancin
Time frame: Day 1 through end of oritavancin IV infusion
Concomitant antibiotics include those used between the first and last dose of oritavancin. The number of participants and the type of antibiotic taken will be presented.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- 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
Global Health Science Center
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gram-Positive Bacterial Infections, run by Melinta Therapeutics, Inc. at 21 sites 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 2 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Types Of Primary Infections Being Treated With Oritavancin (time frame: Day 1). The study lists 7 primary outcomes in all. 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 12 Mar 2018.