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

• Sponsor: Melinta Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03159403
• Collaborator: (none)
• Enrollment: 325
• Locations: 21
• Actual Duration (Months): 10.8
• Patients Per Site: 15.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study is a retrospective, observational study to evaluate oritavancin use in participants under real world conditions.

Condition or Disease	Intervention/Treatment	Phase
Gram-Positive Bacterial Infections	Drug: Oritavancin

Study Design

• Study Type: Observational
• Actual Enrollment: 325 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Apr 12, 2017
• Actual Primary Completion Date: Feb 15, 2018
• Actual Study Completion Date: Mar 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Oritavancin; This study is an observational study. All participants were administered oritavancin prior to enrollment in this study.; Other Names: Orbactiv®

Outcome Measures

Primary Outcome Measures

1. Types Of Primary Infections Being Treated With Oritavancin [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).

2. Classification Of Primary Infections Being Treated With Oritavancin [Day 1]

   The classification of primary infection refers to whether a skin or skin structure infection was cellulitis, abscess, wound, or other.

3. Proportion Of Participants With Positive Cultures For Gram Positive, Gram Negative, And Anaerobic Pathogens From The Infected Site [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.

4. Duration Of Treatment With Oritavancin [Day 1 through end of oritavancin IV infusion]

   The number of days of treatment with oritavancin will be presented.

5. Proportion Of Participants With A Clinical Outcome Of Cure, Improved, or Failure [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

6. Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence [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

7. Use Of Concomitant Antibiotics With Oritavancin [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Infectious Disease and Infusion	Birmingham	Alabama	United States	35243
2	Santa Barbara Cottage Hospital	Santa Barbara	California	United States	93105
3	Florida Infectious Disease Care	Fort Myers	Florida	United States	33912
4	Infectious Diseases Associates of North Central Florida, LLC	Ocala	Florida	United States	34471
5	WellStar Health System - Kennestone	Marietta	Georgia	United States	30060
6	Snake River Research, PLLC	Idaho Falls	Idaho	United States	83404
7	St. Vincent Hospital and Health Care Center, Inc.	Indianapolis	Indiana	United States	46260
8	Methodist Jennie Edmundson Hospital	Council Bluffs	Iowa	United States	51503
9	IDC Clinical Research, LLC	Wichita	Kansas	United States	67214
10	Clinical Infectious Disease Specialists	Las Vegas	Nevada	United States	89128
11	New York-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York	United States	11215
12	Erie County Medical Center	Buffalo	New York	United States	14215
13	Trinity Health Medical Group	Minot	North Dakota	United States	58701
14	Infectious Diseases Consultants of OKC	Oklahoma City	Oklahoma	United States	73109
15	TruCare Internal Medicine and Infectious Diseases	DuBois	Pennsylvania	United States	15801
16	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
17	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
18	Center for Infectious Diseases & Travel Medicine	El Paso	Texas	United States	79902
19	Houston Center For Infectious Diseases	The Woodlands	Texas	United States	77380
20	Infectious Disease and Pulmonary	Victoria	Texas	United States	77901
21	Foot & Ankle Institute	Saint George	Utah	United States	84770

Sponsors and Collaborators

• Melinta Therapeutics, Inc.

Investigators

• Study Director: Medical Information, Global Health Science Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melinta Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03159403
• Other Study ID Numbers: MDCO-ORI-15-05
• First Posted: May 18, 2017
• Last Update Posted: Mar 12, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Positive Bacterial Infections; Oritavancin

Study Results

No Results Posted as of Mar 12, 2018