WithdrawnPhase 4

Oritavancin for Staphylococcus Aureus Infections in Opioid Users

Stopped: COVID 19 pandemic

United States0Started 2019-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin

Timeframe: 6 weeks

Frequency of relapse of infection

Timeframe: 6 weeks

Trial details

NCT IDNCT03761953

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-24