Oritavancin for Staphylococcus Aureus Infections in Opioi... | NCT03761953

Studies
Oritavancin for Staphylococcus Aureus Infections in Opioid Users

NCT03761953

Sponsor

University of Pennsylvania

Status

Withdrawn

Last Update Posted

Apr 6, 2022Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Endocarditis

Interventions

Oritavancin Injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID 19 pandemic

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Mar 24, 2022Actual

Completion Date

Mar 24, 2022Actual

First Submitted Date

Nov 9, 2018

First Submission Date that Met QC Criteria

Nov 30, 2018

First Posted Date

Dec 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2022

Last Update Posted Date

Apr 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This will be a pilot single-arm study consisting of 15 participants evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S. aureus) in opioid users.

The purpose of this pilot proposal is to collect information for a subsequent large, randomized intervention. Primary endpoints will be 1) Safety and tolerability, and 2) Duration of hospitalization and rate of recurrence.

Detailed Description

This will be an early phase, single center, open label pilot study of 15 participants designed to evaluate the effects of oritavancin in patients with Opioid Use Disorder and/or Intravenous Drug Use and systemic S. aureus infections. In this study systemic infections refers to bacteremia or Infectious Endocarditis. Participants who meet inclusion and exclusion criteria will receive a single 1200mg infusion of oritavancin to complete 4 weeks of antibiotic therapy (including the inpatient phase) for isolated bacteremia and 6 weeks for IE. Participants will be evaluated weekly until completion of treatment and then at week 4 and week 6 after the infusion of oritavancin. Participants will have blood drawn at each visit to monitor for toxicity and pharmacokinetics and will be evaluated clinically and by culture for the presence of relapse of the infection. At the last visit, participants will have an echocardiogram.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oritavancin	Experimental	Single IV infusion of 1200mg of oritavancin	Drug: Oritavancin Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oritavancin Injection	Drug	single 1200mg infusion of IV oritavancin.	Oritavancin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin	Safety	6 weeks
Frequency of relapse of infection	Efficacy	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Duration of hospitalization	Duration of hospitalization	6 weeks
Relapse of systemic S. aureus infections	Relapse of systemic S. aureus infections. Relapse will be defined as an isolation of the same S. aureus strain in subsequent cultures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age and older
Systemic infection with S. aureus
Afebrile for >48 hours
Negative blood cultures for at least 48 hours
Absolute neutrophil count (ANC) equal or greater 750/mm3
Hemoglobin > 9.0 g/dL
Platelet count equal or > 50,000/mm3
Creatinine < 2.0 x ULN
AST ; ALT, and alkaline phosphatase < 2.0 x ULN
Willing to use a medically accepted method of contraception

Exclusion Criteria:

Require valve replacement surgery
Have prosthetic material in body (This includes prosthetic heart valves and/or prosthetic joints)
Septic emboli to central nervous system or lungs
Breast feeding during entire participation
Pregnant
Polymicrobial infection
Require anticoagulation
Allergy to vancomycin or oritavancin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pablo Tebas, MD	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Unit. University of Pennsylvania		Philadelphia	Pennsylvania	19104--607	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C100708	oritavancin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

This will be a pilot single-arm study consisting of 15 patients evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S. aureus) in opioid users.