Browsing by Subject "Endocarditis"

Now showing 1 - 6 of 6
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    ItemOpen Access
    Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial.
    (Trials, 2022-05) Turner, Nicholas A; Zaharoff, Smitha; King, Heather; Evans, Scott; Hamasaki, Toshimitsu; Lodise, Thomas; Ghazaryan, Varduhi; Beresnev, Tatiana; Riccobene, Todd; Patel, Rinal; Doernberg, Sarah B; Rappo, Urania; Fowler, Vance G; Holland, Thomas L; Antibacterial Resistance Leadership Group (ARLG)

    Background

    Staphylococcus aureus bacteremia is a life-threatening infection and leading cause of infective endocarditis, with mortality rates of 15-50%. Treatment typically requires prolonged administration of parenteral therapy, itself associated with high costs and potential catheter-associated complications. Dalbavancin is a lipoglycopeptide with potent activity against Staphylococcus and a long half-life, making it an appealing potential therapy for S. aureus bacteremia without the need for durable central venous access.

    Methods

    DOTS is a phase 2b, multicenter, randomized, assessor-blinded, superiority, active-controlled, parallel-group trial. The trial will enroll 200 adults diagnosed with complicated S. aureus bacteremia, including definite or possible right-sided infective endocarditis, who have been treated with effective antibiotic therapy for at least 72 h (maximum 10 days) and with subsequent clearance of bacteremia prior to randomization to study treatment. Subjects will be randomized 1:1 to complete their antibiotic treatment course with either two doses of dalbavancin on days 1 and 8, or with a total of 4-8 weeks of standard intravenous antibiotic therapy. The primary objective is to compare the Desirability of Outcome Ranking (DOOR) at day 70 for patients randomized to dalbavancin versus standard of care. Key secondary endpoints include quality of life outcomes and pharmacokinetic analyses of dalbavancin.

    Discussion

    The DOTS trial will establish whether dalbavancin is superior to standard parenteral antibiotic therapy for the completion of treatment of complicated S. aureus bacteremia.

    Trial registration

    US National Institutes of Health ClinicalTrials.gov NCT04775953 . Registered on 1 March 2021.
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    Infective endocarditis and solid organ transplantation: Only worse outcomes during initial transplantation hospitalization.
    (American heart journal, 2021-10) Eichenberger, Emily M; Dagher, Michael; Sinclair, Matthew R; Maskarinec, Stacey A; Fowler, Vance G; Federspiel, Jerome J

    Background

    The epidemiology, and outcome of infective endocarditis (IE) among solid organ transplant (SOT) recipients is unknown.

    Methods

    We used data from the 2013-2018 Nationwide Readmissions Database (NRD). IE- and SOT-associated hospitalizations were identified using diagnosis and procedure codes. Outcomes included inpatient mortality, length of stay, and inpatient costs. Adjusted analyses were performed using weighted regression models.

    Results

    A total of 99,052 IE-associated hospitalizations, corresponding to a weighted national estimate of 193,164, were included for analysis. Of these, 794 (weighted n = 1,574) were associated with transplant history (SOT-IE). Mortality was not significantly different between SOT-IE and non-SOT-IE (17.2% vs. 15.8%, adjusted relative risk [aRR]: 0.86, 95% confidence interval [CI] [0.71, 1.03]), and fewer SOT-IE patients underwent valve repair or replacement than non-SOT-IE (12.5% vs. 16.2%, aRR 0.82, 95% CI [0.71, 0.95]). We then compared outcomes of patients diagnosed with IE during their index transplant hospitalization (index-SOT-IE) to patients without IE during their transplant hospitalization (index-SOT). Index-SOT-IE occurred most frequently among heart transplant recipients (45.1%), and was associated with greater mortality (27.1% vs. 2.3%, aRR 6.07, 95% CI [3.32, 11.11]).

    Conclusion

    Dual diagnosis of SOT and IE was associated with worse outcomes among SOT recipients during index hospitalization, but not overall among patients with IE.
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    Long-term Risk of Serious Infections and Mortality Among Patients Surviving Drug Use-Associated Infective Endocarditis.
    (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024-07) Figgatt, Mary C; Rosen, David L; Chu, Vivian H; Wu, Li-Tzy; Schranz, Asher J
    Among a statewide cohort of 1874 patients surviving hospitalization for drug use-associated endocarditis during 2017-2020, the 3-year risk of death or future hospitalization was 38% (16% for death before later infection, 14% for recurrent endocarditis, 14% for soft tissue, 9% for bacteremia, 5% for bone/joint, and 4% for spinal infections).
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    Maternal and Fetal Outcomes Associated With Infective Endocarditis in Pregnancy.
    (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021-11) Dagher, Michael M; Eichenberger, Emily M; Addae-Konadu, Kateena L; Dotters-Katz, Sarah K; Kohler, Celia L; Fowler, Vance G; Federspiel, Jerome J

    Background

    Infective endocarditis (IE) is a rare but serious infection that complicates pregnancy. Little is known about IE management and outcomes in this population.

    Methods

    The National Readmissions Database was used to obtain data between October 2015 and October 2018. Billing codes identified admissions for IE in female patients of reproductive age. Demographic characteristics, comorbidities, and outcomes were compared between patients with maternity-associated and nonmaternity-associated IE and obstetric patients who delivered with and without IE. Weighted regressions were used to examine outcomes in adjusted models.

    Results

    We identified 12 602 reproductive-aged female patients with a diagnosis of IE, of which 382 (weighted national estimate, 748) were maternity-associated. Of these cases, 117 (weighted national estimate, 217) occurred during a delivery admission. Compared with patients with nonmaternity-associated IE, maternity-associated infection was associated with younger age (mean, 29.0 vs 36.6 years; P < .001), Medicaid coverage (72.5% vs 47.2%; P < .001), and drug use (76.2% vs 59.8%; P < .001). Mortality was comparable (8.1% vs 10.6%; adjusted rate ratio [aRR], 1.03; 95% confidence interval [CI]: .71-1.48). Compared with patients who delivered without IE, IE complicating delivery was associated with worse maternal and fetal outcomes, including maternal mortality (17.2% vs <0.01%; aRR, 323.32; 95% CI: 127.74-818.37) and preterm birth (55.7% vs 10.1%; aRR, 3.61; 95% CI, 2.58-5.08).

    Conclusions

    Maternity-associated IE does not appear to confer additional risk for adverse outcome over nonmaternity-associated infection. Patients who deliver with IE have worse maternal and fetal outcomes than those whose deliveries are not complicated by IE.
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    The Impact of Discharge Against Medical Advice on Readmission After Opioid Use Disorder-Associated Infective Endocarditis: a National Cohort Study.
    (Journal of general internal medicine, 2023-05) Schranz, Asher J; Tak, Casey; Wu, Li-Tzy; Chu, Vivian H; Wohl, David A; Rosen, David L

    Background

    Hospitalizations for infective endocarditis (IE) associated with opioid use disorder (O-IE) have increased in the USA and have been linked to high rates of discharge against medical advice (DAMA). DAMA represents a truncation of care for a severe infection, yet patient outcomes after DAMA are unknown.

    Objective

    This study aimed to assess readmissions following O-IE and quantify the impact of DAMA on outcomes.

    Design

    A retrospective study of a nationally representative dataset of persons' inpatient discharges in the USA in 2016 PARTICIPANTS: A total of 6018 weighted persons were discharged for O-IE, stratified by DAMA vs. other discharge statuses. Of these, 1331 (22%) were DAMA.

    Main measures

    The primary outcome of interest was 30-day readmission rates, stratified by discharge type. We also examined the total number of hospitalizations during the year and estimated the effect of DAMA on readmission.

    Key results

    Compared with non-DAMA, those experiencing DAMA were more commonly female, resided in metropolitan areas, lower income, and uninsured. Crude 30-day readmission following DAMA was 50%, compared with 21% for other discharge types. DAMA was strongly associated with readmission in an adjusted logistic regression model (OR 3.72, CI 3.02-4.60). Persons experiencing DAMA more commonly had ≥2 more hospitalizations during the period (31% vs. 18%, p<0.01), and were less frequently readmitted at the same hospital (49% vs 64%, p<0.01).

    Conclusions

    DAMA occurs in nearly a quarter of patients hospitalized for O-IE and is strongly associated with short-term readmission. Interventions to address the root causes of premature discharges will enhance O-IE care, reduce hospitalizations and improve outcomes.
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    Trends in Drug Use-Associated Infective Endocarditis and Heart Valve Surgery, 2007 to 2017: A Study of Statewide Discharge Data.
    (Annals of internal medicine, 2019-01) Schranz, Asher J; Fleischauer, Aaron; Chu, Vivian H; Wu, Li-Tzy; Rosen, David L
    Background:Drug use-associated infective endocarditis (DUA-IE) is increasing as a result of the opioid epidemic. Infective endocarditis may require valve surgery, but surgical treatment of DUA-IE has invoked controversy, and the extent of its use is unknown. Objective:To examine hospitalization trends for DUA-IE, the proportion of hospitalizations with surgery, patient characteristics, length of stay, and charges. Design:10-year analysis of a statewide hospital discharge database. Setting:North Carolina hospitals, 2007 to 2017. Patients:All patients aged 18 years or older hospitalized for IE. Measurements:Annual trends in all IE admissions and in IE hospitalizations with valve surgery, stratified by patients' drug use status. Characteristics of DUA-IE surgical hospitalizations, including patient demographic characteristics, length of stay, disposition, and charges. Results:Of 22 825 IE hospitalizations, 2602 (11%) were for DUA-IE. Valve surgery was performed in 1655 IE hospitalizations (7%), including 285 (17%) for DUA-IE. Annual DUA-IE hospitalizations increased from 0.92 to 10.95 and DUA-IE hospitalizations with surgery from 0.10 to 1.38 per 100 000 persons. In the final year, 42% of IE valve surgeries were performed in patients with DUA-IE. Compared with other surgical patients with IE, those with DUA-IE were younger (median age, 33 vs. 56 years), were more commonly female (47% vs. 33%) and white (89% vs. 63%), and were primarily insured by Medicaid (38%) or uninsured (35%). Hospital stays for DUA-IE were longer (median, 27 vs. 17 days), with higher median charges ($250 994 vs. $198 764). Charges for 282 DUA-IE hospitalizations exceeded $78 million. Limitation:Reliance on administrative data and billing codes. Conclusion:DUA-IE hospitalizations and valve surgeries increased more than 12-fold, and nearly half of all IE valve surgeries were performed in patients with DUA-IE. The swell of patients with DUA-IE is reshaping the scope, type, and financing of health care resources needed to effectively treat IE. Primary Funding Source:National Institutes of Health.