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This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oritavancin | Drug | This study is an observational study. All participants were administered oritavancin prior to enrollment in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | Up to 30 days after oritavancin IV infusion |
| Duration Of Treatment With Oritavancin | The number of days of treatment with oritavancin will be presented. | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Information | Global Health Science Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Infectious Disease and Infusion | Birmingham | Alabama | 35243 | United States | ||
| Santa Barbara Cottage Hospital |
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| 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:
| 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. | Day 1 through end of oritavancin IV infusion |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Florida Infectious Disease Care | Fort Myers | Florida | 33912 | United States |
| Infectious Diseases Associates of North Central Florida, LLC | Ocala | Florida | 34471 | United States |
| WellStar Health System - Kennestone | Marietta | Georgia | 30060 | United States |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | United States |
| St. Vincent Hospital and Health Care Center, Inc. | Indianapolis | Indiana | 46260 | United States |
| Methodist Jennie Edmundson Hospital | Council Bluffs | Iowa | 51503 | United States |
| IDC Clinical Research, LLC | Wichita | Kansas | 67214 | United States |
| Clinical Infectious Disease Specialists | Las Vegas | Nevada | 89128 | United States |
| New York-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Trinity Health Medical Group | Minot | North Dakota | 58701 | United States |
| Infectious Diseases Consultants of OKC | Oklahoma City | Oklahoma | 73109 | United States |
| TruCare Internal Medicine and Infectious Diseases | DuBois | Pennsylvania | 15801 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Center for Infectious Diseases & Travel Medicine | El Paso | Texas | 79902 | United States |
| Houston Center For Infectious Diseases | The Woodlands | Texas | 77380 | United States |
| Infectious Disease and Pulmonary | Victoria | Texas | 77901 | United States |
| Foot & Ankle Institute | St. George | Utah | 84770 | United States |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100708 | oritavancin |
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