Outpatient Parenteral Antimicrobial Therapy Plus Buprenorphine for Opioid Use Disorder and Severe Injection-related Infections.
Ontology highlight
ABSTRACT: Clinical trials registration
NCT03048643.
SUBMITTER: Fanucchi LC
PROVIDER: S-EPMC7931831 | biostudies-literature | 2020 Mar
REPOSITORIES: biostudies-literature
Publications
Outpatient Parenteral Antimicrobial Therapy Plus Buprenorphine for Opioid Use Disorder and Severe Injection-related Infections.
Fanucchi Laura C LC Walsh Sharon L SL Thornton Alice C AC Nuzzo Paul A PA Lofwall Michelle R MR
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20200301 6
In a pilot randomized trial in persons with opioid use disorder hospitalized with injection-related infections, an innovative care model combining outpatient parenteral antimicrobial therapy with buprenorphine treatment had similar clinical and drug use outcomes to usual care (inpatient intravenous antibiotic completion) and shortened hospital length of stay by 23.5 days.<h4>Clinical trials registration</h4>NCT03048643. ...[more]
Similar Datasets
Project description:IntroductionA marked increase in hospitalizations for severe, injection-related infections (SIRI) has been associated with the opioid epidemic. Outpatient parenteral antibiotic therapy (OPAT) is typically not offered to persons with opioid use disorder (OUD) and SIRI, though increasing evidence suggests it may be feasible and safe. This study evaluates the efficacy and cost-effectiveness of an integrated care model combining Buprenorphine treatment of OUD with OPAT for SIRI (B-OPAT) compared with treatment as usual on key OUD, infectious disease, and health economic outcomes. B-OPAT expands and incorporates key elements of established clinical models, including inpatient initiation of buprenorphine for OUD, inpatient infectious disease consultation for SIRI, office-based treatment of OUD, and OPAT, and includes more frequent clinical outpatient visits than standard OPAT. A qualitative evaluation is included to contextualize effectiveness outcomes and identify barriers and facilitators to intervention adoption and implementation.MethodsB-OPAT is a single-site, randomized, parallel-group, superiority trial recruiting 90 adult inpatients hospitalized with OUD and SIRI who require at least 2 weeks of intravenous (IV) antibiotic therapy. After screening, eligible participants are randomized 1:1 to either discharge once medically stable to an integrated outpatient treatment care model combining Buprenorphine and OPAT (B-OPAT) or to Treatment As Usual (TAU). The primary outcome measure is the proportion of urine samples negative for illicit opioids in the 12 weeks after discharge from the hospital. Key secondary OUD outcomes include self-reported number of days of illicit opioid abstinence and 12-week retention in buprenorphine treatment. The infection outcomes are completion of recommended IV antibiotic therapy, peripherally inserted central catheter (PICC) complications, and readmission related to primary SIRI.ConclusionsThe B-OPAT study will help address the important question of whether it is clinically effective and cost-effective to discharge persons with OUD and SIRI to an integrated outpatient care model combining OUD treatment with OPAT relative to TAU (Clinicaltrials.gov Identifier: NCT04677114).
| S-EPMC9277431 | biostudies-literature
Project description:Outpatient parenteral antimicrobial therapy (OPAT) is overused in cases where highly bioavailable oral alternatives would be equally effective. However, the scope of OPAT use for children nationwide is poorly understood. Our objective was to characterize OPAT use and clinical outcomes for a large population of pediatric Medicaid enrollees treated with OPAT.We analyzed the Truven MarketScan Medicaid claims database between 2009 and 2012. An OPAT episode was identified by capturing children with claims data indicating home infusion therapy for an intravenous antimicrobial. We characterized OPAT use by describing patient demographics, diagnoses, and antimicrobials prescribed. We categorized an antimicrobial as highly bioavailable if ?80% systemic exposure was expected from the peroral dose. We also determined the percentage of OPAT recipients in whom a follow-up healthcare encounter occurred during the OPAT episode in either the emergency department or as a hospital admission. We reviewed the primary diagnoses associated with these healthcare encounters to determine whether it was related to OPAT.We identified 3433 OPAT episodes in 2687 patients. A total of 4774 antimicrobials were prescribed during these episodes. Ceftriaxone and vancomycin were the most commonly prescribed antimicrobials. Highly bioavailable antimicrobials accounted for 34% of antimicrobials used for OPAT. An emergency department visit or hospital admission occurred during 38% of OPAT episodes, among which 61% were OPAT-related.The high rate of medical encounters associated with OPAT in this cohort and the common prescribing of highly bioavailable antimicrobials underscore the opportunities for antimicrobial stewardship of pediatric OPAT.
| S-EPMC5907854 | biostudies-other
Project description:BackgroundAlthough widely accepted for adults, the safety of outpatient parenteral antimicrobial therapy (OPAT) in very old patients has not been examined.MethodsNonagenarians (age ≥90 years) discharged from the hospital on OPAT over a 5-year period were identified from the Cleveland Clinic OPAT Registry. Three matched controls (<90 years) were selected for each nonagenarian. Times to OPAT-related emergency department (ED) visit and OPAT-related readmission were compared across the 2 groups in multivariable subdistribution proportional hazards competing risks regression models. Incidence of adverse drug events and vascular access complications were compared using negative binomial regression.ResultsOf 126 nonagenarians and 378 controls, 7 were excluded for various reasons. Among the remaining 497 subjects, 306 (62%) were male, 311 (63%) were treated for cardiovascular or osteoarticular infections, and 363 (73%) were discharged to a residential health care facility. The mean (SD) ages of nonagenarians and controls were 92 (2) and 62 (16) years, respectively. Compared with matched controls, being a nonagenarian was not associated with increased risk of OPAT-related ED visit (hazard ratio [HR], 0.77; 95% CI, 0.33-1.80; P = .55), OPAT-related readmission (HR, 0.78; 95% CI, 0.28-2.16; P = .63), adverse drug event from OPAT medications (incidence rate ratio [IRR], 1.00; 95% CI, 0.43-2.17; P = .99), or vascular access complications (IRR, 0.66; 95% CI, 0.27-1.51; P = .32). Nonagenarians had a higher risk of death overall (HR, 2.64; 95% CI, 1.52-4.58; P < .001), but deaths were not from OPAT complications.ConclusionsCompared with younger patients, OPAT in nonagenarians is not associated with higher risk of OPAT-related complications. OPAT can be provided as safely to nonagenarians as to younger patients.
| S-EPMC7532659 | biostudies-literature
Project description:BackgroundThe incidence of multi-drug resistant ESBL-associated urinary tract infections (UTIs) is increasing globally. Patients with abnormal renal tract anatomy and other co-morbidities are at increased risk of complicated UTI and ESBL-associated infections. The duration and safety of OPAT for this cohort of patients is unknown.ObjectivesThis study aims to provide an evidence base to support decision-making regarding duration of antibiotic treatment for complicated UTIs.MethodsWe retrospectively reviewed all patients receiving ertapenem with or without adjunctive fosfomycin for complicated UTIs in the OPAT service of our tertiary infectious diseases hospital. All data had been collected prospectively as part of routine clinical care. Our primary outcomes were microbiological and clinical cure of UTI.ResultsWe identified 33 treatment episodes of ertapenem use for UTIs. 76% episodes related to pyelonephritis or urosepsis diagnoses. Renal tract abnormalities or prior urological surgery were present in 45% of patients. The median duration of appropriate parenteral antibiotic therapy in our study was 6 days. Clinical cure was achieved with short-course parenteral treatment alone in 81% of patients and this increased to 96% when adjunctive fosfomycin was used. There was a single treatment failure resulting in hospital admission.ConclusionsShort duration ertapenem via OPAT with or without adjunctive fosfomycin is safe and effective for the treatment of complicated UTIs. Further studies are required to inform optimal treatment strategies and publication of guidelines in this field.
| S-EPMC6762133 | biostudies-literature
Project description:BackgroundBUP-XR (RBP-6000 or SUBLOCADE) is the first Food and Drug Administration-approved subcutaneously administered monthly extended-release buprenorphine medication for the treatment of moderate or severe opioid use disorder. The primary objective of this phase III study was to assess the long-term safety, tolerability, and efficacy of BUP-XR.MethodsThis open-label multicenter study in adults with moderate or severe opioid use disorder enrolled 257 participants from a previously conducted placebo-controlled, double-blind phase III study (rollover group) and 412 de novo participants not previously treated with BUP-XR. Participants received an initial injection of BUP-XR 300 mg and subsequent monthly 300 mg or 100 mg flexible doses. By study end, participants received up to 12 injections.ResultsOverall, 66.8% of participants reported more than 1 treatment-emergent adverse event (TEAE). Injection-site TEAEs (13.2% of participants) were mostly mild or moderate in severity. There were no clinically meaningful changes in safety assessments. An integrated analysis of the double-blind and open-label study participants showed that the incidence of TEAEs, including injection-site TEAEs, was lower in the second 6 months of treatment versus the first 6 months. After 12 months of treatment, 61.5% of the rollover participants and 75.8% of the de novo participants were abstinent. Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants.ConclusionsThis study demonstrates that the clinical benefits and acceptable safety profile of BUP-XR demonstrated in the 6-month double-blind study are sustained over a 12-month open-label study, with lower incidence of TEAEs in the second 6 months of treatment.
| S-EPMC7188268 | biostudies-literature
Project description:A cluster of cefepime-induced neutropenia (CIN) was identified from June 2017 to May 2018 in a regional outpatient parenteral antimicrobial therapy population. Our data suggest prolonged courses of cefepime (≥2 weeks), administered by rapid intravenous push, were associated with a higher risk of CIN.
| S-EPMC6637276 | biostudies-literature
Project description:The OVIVA study demonstrated noninferiority for managing bone and joint infections (BJIs) with oral antibiotics. We report that 79.7% of OPAT patients being treated for BJIs at our center would be eligible for oral antibiotics, saving a median (IQR) 19.5 IV-antibiotic days (8.5-37) and GBP 1234 (569-2594) per patient.
| S-EPMC7312207 | biostudies-literature
Project description:ImportanceAlthough substantial evidence supports buprenorphine for treatment of opioid use disorder (OUD) in controlled trials, prospective study of patient outcomes in clinical implementation of emergency department (ED) buprenorphine treatment is lacking.ObjectiveTo examine the association between buprenorphine treatment in the ED and follow-up engagement in OUD treatment 1 month later.Design, setting, and participantsThis multisite cohort study was conducted in 7 California EDs participating in a statewide implementation project to improve access to buprenorphine treatment. The study population included ED patients aged at least 18 years identified with OUD between April 1, 2021, and June 30, 2022. Data analysis was performed in October 2023.ExposureAll participants were offered buprenorphine treatment for OUD (either in ED administration, prescription, or both), the uptake of which was examined as the exposure of interest.Main outcomes and measuresThe primary outcome was engagement in OUD treatment 30 days after the ED visit, determined by patient report or clinical documentation. The association of ED buprenorphine treatment with subsequent OUD treatment engagement was estimated using hierarchical generalized linear models.ResultsThis analysis included 464 ED patients with OUD. Their median age was 36.0 (IQR, 29.0-38.7) years, and most were men (343 [73.9%]). With regard to race and ethnicity, 64 patients (13.8%) self-identified as non-Hispanic Black, 183 (39.4%) as Hispanic, and 185 as non-Hispanic White (39.9%). Most patients (396 [85.3%]) had Medicaid insurance, and more than half (262 [57.8%]) had unstable housing. Self-reported fentanyl use (242 [52.2%]) and a comorbid mental health condition (328 [71.5%]) were common. Interest in buprenorphine treatment was high: 398 patients (85.8%) received buprenorphine treatment; 269 (58.0%) were administered buprenorphine in the ED and 339 (73.1%) were prescribed buprenorphine. With regard to OUD treatment engagement at 30 days after the ED visit, 198 participants (49.7%) who received ED buprenorphine treatment remained engaged compared with 15 participants (22.7%) who did not receive ED buprenorphine treatment. An association of ED buprenorphine treatment with subsequent OUD treatment engagement at 30 days was observed (adjusted risk ratio, 1.97 [95% CI, 1.27-3.07]).Conclusions and relevanceThe findings of this cohort study suggest that among patients with OUD presenting to EDs implementing low-threshold access to medications for OUD, buprenorphine treatment was associated with a substantially higher likelihood of follow-up treatment engagement 1 month later. Future research should investigate techniques to optimize both the uptake and effectiveness of buprenorphine initiation in low-threshold settings such as the ED.
| S-EPMC10825722 | biostudies-literature
Project description:ImportanceAgonist medications for opioid use disorder (MOUD), buprenorphine and methadone, in carceral settings might reduce the risk of postrelease opioid overdose but are uncommonly offered. In April 2019, the Massachusetts Department of Correction (MADOC), the state prison system, provided buprenorphine for incarcerated individuals in addition to previously offered injectable naltrexone.ObjectiveTo evaluate postrelease outcomes after buprenorphine implementation.Design, setting, and participantsThis cohort study with interrupted time-series analysis used linked data across multiple statewide data sets in the Massachusetts Public Health Data Warehouse stratified by sex due to differences in carceral systems. Eligible participants were individuals sentenced and released from a MADOC facility to the community. The study period for the male sample was January 2014 to November 2020; for the female sample, January 2015 to October 2019. Data were analyzed between February 2022 and January 2024.ExposureApril 2019 implementation of buprenorphine during incarceration.Main outcomes and measuresReceipt of MOUD within 4 weeks after release, opioid overdose, and all-cause mortality within 8 weeks after release, each measured as a percentage of monthly releases who experienced the outcome. Segmented linear regression analyzed changes in outcome rates after implementation.ResultsA total of 15 225 individuals were included. In the male sample there were 14 582 releases among 12 688 individuals (mean [SD] age, 35.0 [10.8] years; 133 Asian and Pacific Islander [0.9%], 4079 Black [28.0%], 4208 Hispanic [28.9%], 6117 White [41.9%]), a rate of 175.7 releases per month; the female sample included 3269 releases among 2537 individuals (mean [SD] age, 34.9 [9.8] years; 328 Black [10.0%], 225 Hispanic [6.9%], 2545 White [77.9%]), a rate of 56.4 releases per month. Among male participants at 20 months postimplementation, the monthly rate of postrelease buprenorphine receipt was higher than would have been expected under baseline trends (21.2% vs 10.6% of monthly releases; 18.6 additional releases per month). Naltrexone receipt was lower than expected (1.0% vs 6.0%; 8.8 fewer releases per month). Monthly rates of methadone receipt (1.4%) and opioid overdose (1.8%) were not significantly different than expected. All-cause mortality was lower than expected (1.9% vs 2.8%; 1.5 fewer deaths per month). Among female participants at 7 months postimplementation, buprenorphine receipt was higher than expected (31.6% vs 9.5%; 12.4 additional releases per month). Naltrexone receipt was lower than expected (3.4% vs 7.2%) but not statistically significantly different. Monthly rates of methadone receipt (1.1%), opioid overdose (4.8%), and all-cause mortality (1.6%) were not significantly different than expected.Conclusions and relevanceIn this cohort study of state prison releases, postrelease buprenorphine receipt increased and naltrexone receipt decreased after buprenorphine became available during incarceration.
| S-EPMC10949092 | biostudies-literature
Project description:Extensive 12-lead electrocardiogram monitoring and drug concentrations were obtained during development of BUP-XR, a monthly subcutaneous injection for the treatment of opioid use disorder (OUD). Matched QT and plasma drug concentrations (11,925) from 1,114 subjects were pooled from 5 studies in OUD. A concentration-QT model was developed, which accounted for confounding factors (e.g., comedications) affecting heart rate and heart rate-corrected QT interval (QTc). Bias-corrected nonparametric two-sided 90% confidence intervals (CIs) were derived for the mean predicted effect of BUP-XR on QTc (?QTc) at therapeutic and supratherapeutic doses. Changes in QTc were associated with age, central vs. noncentral reading, sex, methadone, and barbiturates. The upper 90% CI of ?QTc was 0.29, 0.67, and 1.34 ms at the steady-state peak concentration (Cmax ) for 100, 300, and 2 × 300 mg doses, respectively. An effect of BUP-XR on QT can be ruled out at therapeutic and supratherapeutic doses of BUP-XR, after accounting for covariates that may influence heart rate and QT interval in OUD.
| S-EPMC6766787 | biostudies-literature