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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA048892 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will assess the efficacy of an integrated outpatient treatment model for persons with opioid use disorder and injection related infections. The investigators hypothesize that outpatient antibiotic treatment coupled with comprehensive treatment for opioid use disorder will demonstrate a safe and effective way to manage patients. Results could improve the current protocols for the treatment of individuals with opioid use disorder and severe infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient Parenteral Antibiotic Therapy (OPAT) | Experimental | Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT). |
|
| Treatment as Usual (TAU) | Active Comparator | Patients with OUD and severe, injection-related infections (SIRI) will receive usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine and Outpatient Parenteral Antibiotic Therapy | Drug | Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD. |
| Measure | Description | Time Frame |
|---|---|---|
| Illicit Opioid Use | Proportion of urine samples with negative urine drug screen for illicit opioid use | 12 weeks after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Recommended IV Antibiotic Therapy | number of patients who completed recommended IV antibiotic therapy | up to 12 weeks (duration of IV antibiotic course as determined by treating physician) |
| Abstinence From Illicit Opioid |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40515 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35847566 | Background | Fanucchi LC, Murphy SM, Surratt H, Kapadia SN, Walsh SL, Grubbs JA, Thornton AC, Nuzzo P, Lofwall MR. Design and protocol of the Buprenorphine plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) study: a randomized clinical trial of integrated outpatient treatment of opioid use disorder and severe, injection-related infections. Ther Adv Infect Dis. 2022 Jul 11;9:20499361221108005. doi: 10.1177/20499361221108005. eCollection 2022 Jan-Dec. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT) | Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT). |
| FG001 | Treatment as Usual (TAU) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 12 Week |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2025 | Mar 25, 2026 |
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|
| Buprenorphine and standard of care antibiotic treatment | Drug | All participants will receive treatment of OUD and the infection per usual clinical care. |
|
|
Self-reported number of days of illicit opioid abstinence
| 12 weeks after hospital discharge |
| Injection Drug Use | Self-reported number of days of injection use of any drug | 12 weeks after hospital discharge |
| Outpatient Treatment Retention | Number of days patients remain in treatment. | 12 weeks after hospital discharge |
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 6 Month |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT) | Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT). |
| BG001 | Treatment as Usual (TAU) | Patients with OUD and severe, injection-related infections (SIRI) will receive usual care. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Illicit Opioid Use | Proportion of urine samples with negative urine drug screen for illicit opioid use | All participants were analyzed, including participants that did not complete the full 12 weeks. | Posted | Number | Proportion of UDS samples | 12 weeks after hospital discharge | Urine samples | Urine samples |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Completion of Recommended IV Antibiotic Therapy | number of patients who completed recommended IV antibiotic therapy | All participants were analyzed, including participants that did not complete the full 12 weeks. | Posted | Count of Participants | Participants | up to 12 weeks (duration of IV antibiotic course as determined by treating physician) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Abstinence From Illicit Opioid | Self-reported number of days of illicit opioid abstinence | All participants were analyzed, including participants that did not complete the full 12 weeks. | Posted | Mean | Standard Error | Days | 12 weeks after hospital discharge |
|
| |||||||||||||||||||||||||||||||
| Secondary | Injection Drug Use | Self-reported number of days of injection use of any drug | All participants were analyzed, including participants that did not complete the full 12 weeks. | Posted | Mean | Standard Error | Days | 12 weeks after hospital discharge |
|
| |||||||||||||||||||||||||||||||
| Secondary | Outpatient Treatment Retention | Number of days patients remain in treatment. | All participants were analyzed, including participants that did not complete the full 12 weeks. | Posted | Mean | Standard Error | Days | 12 weeks after hospital discharge |
|
|
From enrollment until end of follow-up, up to 6 months from index hospitalization discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT) | Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT). | 2 | 36 | 14 | 36 | 32 | 36 |
| EG001 | Treatment as Usual (TAU) | Patients with OUD and severe, injection-related infections (SIRI) will receive usual care. | 3 | 35 | 20 | 35 | 30 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Adverse reaction to antibiotics | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| COVID pneumonia | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Cytopenia | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Delirium/intoxication - stimulant | Psychiatric disorders | MedDRA v28.1 | Systematic Assessment |
| |
| DKA | Metabolism and nutrition disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Embolization of valve vegetation | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Encephalopathy due to cirrhosis | Nervous system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Endocarditis needing valve replace/repair | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Fatal overdose | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Intracerebral hemorrhage | Vascular disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Nausea/vomiting/diarrhea w/ hospitalization | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Newly flail tricuspid valve | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Nonfatal overdose | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Orthopedic surgery | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Pain related to SIRI resulting in hospitalization | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Pneumocosis coli | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Prosthetic valve endocarditis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Pulmonary embolism | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Septic arthritis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Valve replacement | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Vertebral osteomyelitis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Agitation | Cardiac disorders | MedDRA v28.1 | Systematic Assessment |
| |
| AKI | Renal and urinary disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Anemia | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Blood in stool | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Candidiasis (vaginal, intertrigo) | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| CLABSI | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| COVID Infection Not Needing Hospitalization | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Cytopenia | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Delirium/intoxication - stimulant | Psychiatric disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Difficult removing PICC | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Dosing error | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Drowsiness | General disorders | MedDRA v28.1 | Systematic Assessment |
| |
| DVT and thrombophlebitis | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Fall | Musculoskeletal and connective tissue disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Fever | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Fungal prosthetic valve IE | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Hair loss | Skin and subcutaneous tissue disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Headache not related to buprenorphine | Nervous system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Heart block | Cardiac disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Hemoptysis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Hematoma at surgical site | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Hernia repair | Skin and subcutaneous tissue disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Hypoglycemia / Hyperglycemia | Metabolism and nutrition disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Hypokalemia / Hyperkalemia | Renal and urinary disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Hypomagnesemia | Renal and urinary disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Injection-site reaction (Sublocade) | General disorders | MedDRA v28.1 | Systematic Assessment |
| |
| IV infiltrate | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| LE Edema | Cardiac disorders | MedDRA v28.1 | Systematic Assessment |
| |
| LE Edema | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| LE Edema | Vascular disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Limp | Musculoskeletal and connective tissue disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Mood symptoms (depression/anxiety) | Psychiatric disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Mouth / dental pain | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Nausea / constipation | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Nausea/vomiting/diarrhea | Gastrointestinal disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Nausea/vomiting/diarrhea | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Neurologic symptoms related to substance use | Nervous system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Opioid intoxication | Psychiatric disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Opioid withdrawal | Psychiatric disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Ottis media | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Over-infusion of antibiotics | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Pain - Unrelated to SIRI | Musculoskeletal and connective tissue disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Pain after I&D | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Pain at chest tube site | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Pain related to SIRI | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| PICC Displacement | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| PICC misplacement | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| PICC not flushing / slow blood return | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| PICC retraction | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Pneumothorax | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Possible allergy - swelling | Immune system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Possible PICC misuse | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Problem with abscess drain | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Rash | Immune system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Rash from adhesive | Skin and subcutaneous tissue disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Skin abscess / cellulitis | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Skin photosensitivity | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Stroke-like symptoms | Nervous system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Suicidal thoughts | Psychiatric disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Sunburn | Skin and subcutaneous tissue disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Superficial venous thrombosis | Injury, poisoning and procedural complications | MedDRA v28.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Thyroid nodule | Endocrine disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Toe auto-amputation | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| URI +/- fever | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| UTI | Infections and infestations | MedDRA v28.1 | Systematic Assessment |
| |
| Weakness | General disorders | MedDRA v28.1 | Systematic Assessment |
| |
| Weight loss | Metabolism and nutrition disorders | MedDRA v28.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Lofwall | University of Kentucky | 859-323-9321 | michelle.lofwall@uky.edu |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2024 | Feb 24, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 11, 2024 | May 7, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D004698 | Endocarditis, Subacute Bacterial |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004697 | Endocarditis, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D053821 | Cardiovascular Infections |
| D002318 | Cardiovascular Diseases |
| D004696 | Endocarditis |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| C000627685 | Sublocade |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Incarcerated |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|