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  • 1
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 8, No. Supplement_1 ( 2021-12-04), p. S632-S633
    Abstract: Nontuberculous mycobacteria (NTM) are resistant to numerous antibiotics and lead to significant morbidity and mortality. Omadacycline (OMC) is an aminomethylcycline antibiotic that is Food and Drug Administration-approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Furthermore, OMC has shown in vitro activity against NTM. Given that real-world evidence is lacking, our primary objective was to evaluate the clinical success and tolerability of OMC when used for a variety of NTM infections. Methods This was a multicenter, retrospective, observational study conducted from January 2020 to June 2021. We included all patients ≥ 18 years of age that received OMC of any indication for Mycobacterium spp. The primary outcome was clinical success, defined as a lack of all-cause mortality, lack of persistence or re-emergence of infection during or after therapy, and lack of alteration of OMC. Incidence of adverse effects potentially attributable to OMC and reasons for OMC utilization were also analyzed. Results A total of 31 patients were included from 12 geographically distinct academic health systems (median age: 57 (IQR, 45-63) years; 45% male; 81% Caucasian). The majority of isolated pathogens were Mycobacterium abscessus complex (84%) and of those with subspeciation performed (54%), the majority (86%) were subsp. abscessus. The primary infections were of pulmonary origin (67%) and the median (IQR) duration of OMC therapy was 5.3 (3.2-9.4) months. Most isolates did not have OMC susceptibility conducted (87%), while the majority did for tigecycline (90%). Clinical success was reported in 81% of the population. Most patients were on combination antimicrobial therapy, and 39% of patients reported an adverse effect while on OMC (58% gastrointestinal distress). The majority of patients were prescribed OMC due to ease of administration (61%) and antimicrobial resistance to previous antibiotics (42%). Conclusion OMC may be a potential option for the therapy of NTM infections. Prospective, randomized clinical trials are needed to confirm our preliminary findings. Disclosures Julie V. Philley, MD, Paratek Pharmaceuticals (Advisor or Review Panel member)Paratek Pharmaceuticals, Inc. (Consultant) Michael P. Veve, Pharm.D., Cumberland (Grant/Research Support)Paratek Pharmaceuticals (Research Grant or Support) Michael J. Rybak, PharmD, MPH, PhD, Paratek Pharmaceuticals (Research Grant or Support)
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2757767-3
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  • 2
    In: Antimicrobial Agents and Chemotherapy, American Society for Microbiology
    Abstract: Infections due to nontuberculous mycobacteria (NTM) continue to increase in prevalence, leading to problematic clinical outcomes. Omadacycline (OMC) is an aminomethylcycline antibiotic with FDA orphan drug and fast-track designations for pulmonary NTM infections, including Mycobacteroides abscessus (MAB). This multicenter retrospective study across 16 U.S. medical institutions from January 2020 to March 2023 examined the long-term clinical success, safety, and tolerability of OMC for NTM infections. The cohort included patients aged ≥18 yr, who were clinically evaluable, and` had been treated with OMC for ≥3 mo without a previous diagnosis of cystic fibrosis. The primary outcome was 3 mo clinical success, with secondary outcomes including clinical improvement and mortality at 6- and 12 mo, persistence or reemergence of infection, adverse effects, and reasons for OMC utilization. Seventy-five patients were included in this analysis. Most patients were female (48/75, 64.0%) or Caucasian (58/75, 77.3%), with a median (IQR) age of 59 yr (49–67). Most had NTM pulmonary disease (33/75, 44.0%), skin and soft tissue disease (19/75, 25.3%), or osteomyelitis (10/75, 13.3%), and Mycobacterium abscessus (60/75, 80%) was the most commonly isolated NTM pathogen. The median (IQR) treatment duration was 6 mo ( 4 – 14 ), and the most commonly co-administered antibiotic was azithromycin (33/70, 47.1%). Three-month clinical success was observed in 80.0% (60/75) of patients, and AEs attributable to OMC occurred in 32.0% (24/75) of patients, leading to drug discontinuation in 9.3% (7/75).
    Type of Medium: Online Resource
    ISSN: 0066-4804 , 1098-6596
    RVK:
    Language: English
    Publisher: American Society for Microbiology
    Publication Date: 2023
    detail.hit.zdb_id: 1496156-8
    SSG: 12
    SSG: 15,3
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  • 3
    In: Personalized Medicine, Future Medicine Ltd, Vol. 18, No. 3 ( 2021-05), p. 223-232
    Abstract: Aim: We sought to understand how early adopters used pharmacogenomic (PGx) testing for treating depression and attention deficient hyperactivity disorder (ADHD). Patients & methods: We conducted a phone survey with prescribers who had previously ordered an Informed PGx (Progenity, Inc., MI, USA) test. Results: We identified 1037 prescribers in our sampling period. Respondents (n = 64) were predominantly female (61.5%) and in pediatrics (n = 42; 64.6%). PGx testing was used for multiple scenarios (mean 3.3 ± 1.6); the most common was after no response to medication was observed (80%; 51/64). Most respondents state that test results typically reveal an altered metabolizer status. Conclusion: PGx test results ordered by early adopters often reveal altered metabolizers which leads them to change the depression/ADHD medication regimen. Future work should evaluate the clinical utility of PGx testing for depression/ADHD treatment.
    Type of Medium: Online Resource
    ISSN: 1741-0541 , 1744-828X
    Language: English
    Publisher: Future Medicine Ltd
    Publication Date: 2021
    SSG: 15,3
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  • 4
    In: Personalized Medicine, Future Medicine Ltd, Vol. 18, No. 3 ( 2021-05), p. 233-240
    Abstract: Aim: We sought to explore how early adopters use pharmacogenomic (PGx) testing for treating depression and attention-deficit/hyperactivity disorder. Patients & methods: Prescribers of the Informed PGx (Progenity, Inc., Ann Arbor, MI 48108, USA) test completed a phone survey assessing use of PGx testing for different scenarios. We conducted a qualitative thematic text analysis of transcribed audio recordings of open-ended responses (n = 62). Results: PGx testing was used when treating multiple comorbidities or resistant disease, and to ease patients’ concerns with future therapy. Use of PGx testing is influenced by insurance coverage, interpretability of results and results turnaround time. Conclusion: Prescribers used PGx tests to modify medications for complex patients with depression, attention-deficit/hyperactivity disorder and other disorders to alleviate concerns related to adverse effects and lack of effectiveness.
    Type of Medium: Online Resource
    ISSN: 1741-0541 , 1744-828X
    Language: English
    Publisher: Future Medicine Ltd
    Publication Date: 2021
    SSG: 15,3
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  • 5
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2022
    In:  Obesity Surgery Vol. 32, No. 5 ( 2022-05), p. 1523-1530
    In: Obesity Surgery, Springer Science and Business Media LLC, Vol. 32, No. 5 ( 2022-05), p. 1523-1530
    Abstract: Human immunodeficiency virus (HIV)–related mortality has decreased secondary to advances in antiretroviral therapy (ART), and the incidence of obesity in this population is increasing. Bariatric surgery is an effective method of weight loss, though changes in the gastrointestinal tract may affect ART absorption and virologic suppression. Existing data are limited to case reports studying outdated therapeutic regimens; studies evaluating modern ART regimens are needed. The objective of this study was to determine if undergoing bariatric surgery impacts HIV virologic failure rate at 12 months post-surgery and to characterize the failure population. Materials and Methods This retrospective case series included adults with virologically suppressed HIV on ART who underwent roux-en-y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery between 2000 and 2019 ( n =20) at one of three medical centers within one academic medical system. The primary outcome was proportion of patients with ART failure at 12 months post-surgery. Select additional data collected included CD4+ count, metabolic parameters, postoperative complications, and medication non-adherence. Results A total of 18 patients were included in this analysis. Seventeen of 18 patients (94%) maintained virologic suppression within 12 months post-surgery. There were no significant changes in CD4+ counts before and after surgery. The one failure was an African American woman who underwent sleeve gastrectomy surgery. This patient’s baseline viral load was undetectable and CD4+ count was 263 cells/mm 3 . Conclusion Undergoing bariatric surgery did not increase virologic failure rate in a small cohort of persons living with HIV, and ART non-adherence was associated with virologic failure. Graphical abstract
    Type of Medium: Online Resource
    ISSN: 0960-8923 , 1708-0428
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2087903-9
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  • 6
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2021
    In:  Open Forum Infectious Diseases Vol. 8, No. Supplement_1 ( 2021-12-04), p. S184-S185
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 8, No. Supplement_1 ( 2021-12-04), p. S184-S185
    Abstract: Surveillance of antimicrobial use is a cornerstone of antimicrobial stewardship, though antifungal (AF) use is less frequently characterized. AFs are a major driver of inpatient costs and their use both reflects and drives changes in fungal susceptibility patterns. We report on trends in AF use in a large sample of United States hospitals over time including predictors of AF use. Methods We performed a retrospective analysis of adult inpatient visits between 2016 and 2020 at hospitals contributing data to the Vizient Clinical Database/Clinical Resource Manager (www.vizientinc.com). Inpatient use of systemically administered AFs was investigated as a function of study quarter, diagnosis code, and underlying immunosuppressive condition. Changes in AF use were modeled using logistic and negative binomial regression. Results We examined over 23 million admissions across 470 hospitals, 43% of which were classified as teaching hospitals and 54% of which performed solid organ transplants. During the study period, 4.03% (951,284/23,565,493) of admissions were billed for one or more of the study AFs. Among admissions receiving AFs, 86% received an azole, with the most frequently used agent being fluconazole, which accounted for for 46% of total AF days. Likelihood of AF receipt during admission increased by quarter (OR 1.012, p & lt; 0.001), controlling for length of stay, presence of fungal infection, hematologic malignancy (HM), or solid organ transplant (SOT). Odds of any receipt and days of therapy (DOT) of fluconazole, isavuconazole, posaconazole, and echinocandins increased over the study period while those of voriconazole, itraconazole, and flucytosine decreased; odds of receipt of amphotericin products increased while DOT decreased; flucytosine receipt odds increased while DOT did not change. Only 30% of admissions with AF use were associated with a documented fungal infection, with 93% of these episodes documented as candidiasis. Admissions associated with SOT or HM represented 2% and 3% of all patient-days, but 11% and 25% of total AF days, respectively. Antifungal Utilization Conclusion AF use increased significantly over the study period, with changes across agents and classes. Most AF use occurred in the absence of administratively documented infection and was more common among SOT and HM patients. Disclosures All Authors: No reported disclosures
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2757767-3
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