Endocarditis, BacterialCATS-CARENCT03048643
Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis
A study testing Outpatient parenteral antibiotic therapy in people with Endocarditis, Bacterial and Opioid-use Disorder, run by Laura Fanucchi at 1 site in United States.
Trial summary
Hospitalizations for severe infections associated with opioid use disorder (OUD), such as infective endocarditis (IE), have doubled in the US over the past decade and are frequently prolonged and resource-intensive. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Endocarditis, Bacterial, Opioid-use Disorder, Buprenorphine
- What is being tested?
- Outpatient parenteral antibiotic therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 2 Oct 2018
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meeting OUD by DSM-V criteria
- have IE by Duke's criteria
- candidates for outpatient treatment with buprenorphine
- accepting of buprenorphine treatment
- anticipated to be discharged home after medically stabilized
- requiring ≥ 2 weeks of IV antibiotic therapy
- having ≥ 1 week of IV antibiotic therapy remaining at the time of medical readiness for discharge (as defined by the primary clinical team),
- and providing informed consent.
Who cannot join
- presence of stroke or central nervous system involvement
- clinically active embolic sequelae (e.g. pulmonary sepsis, mycotic aneurysms, splenic abscesses)
- TV treated surgically or endovascularly (AngioVac)
- presence of osteomyelitis
- fungal IE
- patients who require inpatient physical rehabilitation determined by physical or occupational therapy assessment
Show all 17Show fewer
- current pregnancy
- current severe methamphetamine, cocaine, alcohol or benzodiazepine use disorders by DSM-V criteria
- currently enrolled in ongoing MAT for OUD
- hypersensitivity or allergy to buprenorphine
- chronic pain requiring opioids
- class III or IV heart failure
- cirrhosis
- end stage renal disease
- other significant screening laboratory/medical/psychiatric/psychosocial condition that may prevent the volunteer from safely participating in the study in the opinion of the investigator (e.g. currently suicidal)
- pending legal action that could interfere with study participation
- living more than a 45-minute drive from UK given the intense outpatient component to the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CATS-CARE: Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis
Hospitalizations for severe infections associated with opioid use disorder (OUD), such as infective endocarditis (IE), have doubled in the US over the past decade and are frequently prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more) largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional outpatient care program supporting MAT, may support provision of outpatient IV antibiotic therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due to opioid use disorder in the hospital for the full duration of antibiotic treatment) compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically stable).
- Conditions
- Endocarditis, Bacterial, Opioid-use Disorder, Buprenorphine, Outpatient Parenteral Antibiotic Therapy
- Being tested
- Outpatient parenteral antibiotic therapy
- Medical subject headings
- Endocarditis, Bacterial, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient parenteral antibiotic therapyBehavioural
Also called OPAT
Subjects randomized to OPAT will complete IV antibiotic therapy for infective endocarditis as an outpatient according to published guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy for infective endocarditis according to usual care. |
| Outpatient Parenteral Antibiotic Therapy | Experimental | Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy via outpatient parenteral antibiotic therapy (OPAT). Receives: Behavioral: Outpatient parenteral antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit drug use
Participants will be asked by their clinician to self report illicit drug use at their follow up visit 12 weeks after discharge
Measured: 12 weeks after discharge
Secondary outcomes (1)
Completion of recommended IV antibiotic therapy
Participants will be asked by their clinician to self report compliance to the recommended IV antibiotic therapy at their follow up visit 12 weeks after discharge
Measured: 12 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endocarditis, BacterialStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Fanucchi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Fanucchi, University of Kentucky
- Investigators
- Laura Fanucchi, MD, Principal investigator, University of KentuckySharon Walsh, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048643
- Sponsor's protocol ID
- 16-1001-F1V
- Acronym
- CATS-CARE
- Status last verified
- Jan 2019
- First submitted
- 2 Feb 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanucchi LC, Walsh SL, Thornton AC, Nuzzo PA, Lofwall MR. Outpatient Parenteral Antimicrobial Therapy Plus Buprenorphine for Opioid Use Disorder and Severe Injection-related Infections. Clin Infect Dis. 2020 Mar 3;70(6):1226-1229. doi: 10.1093/cid/ciz654.
PubMed 31342057
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CATS-CARE: Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis
- ClinicalTrials.gov ID
- NCT03048643
- Acronym / sponsor ID
- CATS-CARE / 16-1001-F1V
- Conditions
- Endocarditis, Bacterial, Opioid-use Disorder, Buprenorphine, Outpatient Parenteral Antibiotic Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Laura FanucchiUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Hospitalizations for severe infections associated with opioid use disorder (OUD), such as infective endocarditis (IE), have doubled in the US over the past decade and are frequently prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more) largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional outpatient care program supporting MAT, may support provision of outpatient IV antibiotic therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due to opioid use disorder in the hospital for the full duration of antibiotic treatment) compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically stable).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy for infective endocarditis according to usual care. |
| Outpatient Parenteral Antibiotic Therapy | Experimental | Behavioral: Outpatient parenteral antibiotic therapySubjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy via outpatient parenteral antibiotic therapy (OPAT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- meeting OUD by DSM-V criteria
- have IE by Duke's criteria
- candidates for outpatient treatment with buprenorphine
- accepting of buprenorphine treatment
- anticipated to be discharged home after medically stabilized
Key exclusion criteria (17 listed)
- presence of stroke or central nervous system involvement
- clinically active embolic sequelae (e.g. pulmonary sepsis, mycotic aneurysms, splenic abscesses)
- TV treated surgically or endovascularly (AngioVac)
- presence of osteomyelitis
- fungal IE
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 |
|---|---|---|
| Outpatient parenteral antibiotic therapyAlso: OPATSubjects randomized to OPAT will complete IV antibiotic therapy for infective endocarditis as an outpatient according to published guidelines. | Behavioural | Outpatient Parenteral Antibiotic Therapy |
Primary outcome
Illicit drug use
Time frame: 12 weeks after discharge
Participants will be asked by their clinician to self report illicit drug use at their follow up visit 12 weeks after discharge
1 secondary outcome
Completion of recommended IV antibiotic therapy
Time frame: 12 weeks after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 31342057Fanucchi LC, Walsh SL, Thornton AC, Nuzzo PA, Lofwall MR. Outpatient Parenteral Antimicrobial Therapy Plus Buprenorphine for Opioid Use Disorder and Severe Injection-related Infections. Clin Infect Dis. 2020 Mar 3;70(6):1226-1229. doi: 10.1093/cid/ciz654.
- 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.
Laura Fanucchi, MD principal investigator
University of Kentucky
Sharon Walsh, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient parenteral antibiotic therapy in people with Endocarditis, Bacterial and Opioid-use Disorder, run by Laura Fanucchi 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 23 Jan 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Illicit drug use (time frame: 12 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048643, which also lists 1 linked publication.
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 23 Jan 2019.