Staphylococcus Aureus BacteremiaPhase 4NCT03761953
Oritavancin for Staphylococcus Aureus Infections in Opioid Users
A Phase 4 study testing Oritavancin Injection in people with Staphylococcus Aureus Bacteremia and Staphylococcus Aureus Endocarditis, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
- What is being tested?
- Oritavancin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 24 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Unit. University of Pennsylvania
Philadelphia, Pennsylvania, 19104--607
About this study
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
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.
Read the 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.
- Being tested
- Oritavancin Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oritavancin InjectionDrug
single 1200mg infusion of IV oritavancin.
| Study group | Role | What they receive |
|---|---|---|
| Oritavancin | Experimental | Single IV infusion of 1200mg of oritavancin Receives: Drug: Oritavancin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin
Safety
Measured: 6 weeks
Frequency of relapse of infection
Efficacy
Measured: 6 weeks
Secondary outcomes (4)
Duration of hospitalization
Duration of hospitalization
Measured: 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
Measured: 6 weeks
Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)
Cmin (μg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin
Measured: 6 weeks
Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Patient satisfaction will be measured using The Patient Satisfaction Questionnaire Short Form (PSQ-18)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Jul 2019
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Why it stopped: COVID 19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Tebas, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761953
- Sponsor's protocol ID
- 831334
- Status last verified
- Mar 2022
- First submitted
- 9 Nov 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03761953
- Acronym / sponsor ID
- 831334
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID 19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oritavancin | Experimental | Drug: Oritavancin InjectionSingle IV infusion of 1200mg of oritavancin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oritavancin Injectionsingle 1200mg infusion of IV oritavancin. | Drug | Oritavancin |
Primary outcome
Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin
Time frame: 6 weeks
Safety
Frequency of relapse of infection
Time frame: 6 weeks
Efficacy
4 secondary outcomes
Duration of hospitalization
Time frame: 6 weeks
Relapse of systemic S. aureus infections
Time frame: 6 weeks
Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)
Time frame: 6 weeks
Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Tebas, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oritavancin Injection in people with Staphylococcus Aureus Bacteremia and Staphylococcus Aureus Endocarditis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.