Clinical trial NCT03761953: Oritavancin for Staphylococcus Aureus Infections in Opioid Users
Official title: A Pilot Proof of Concept Single-Center Study of the Use of Oritavancin in Systemic Staphylococcus Aureus Infections in Patients With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Endocarditis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin
timeFrame: 6 weeks
measure: Frequency of relapse of infection
timeFrame: 6 weeks
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: 6 weeks
measure: Relapse of systemic S. aureus infections
timeFrame: 6 weeks
measure: Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)
timeFrame: 6 weeks
measure: Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Clinical Trials Unit. University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Pablo Tebas, MD
role: PRINCIPAL_INVESTIGATOR
References: