Therapy With Allogeneic Severe Acute Respiratory Syndrome Coronavirus-2-Specific T Cells for Persistent Coronavirus Disease 2019 in Immunocompromised Patients.

We administered severe acute respiratory syndrome coronavirus-2 viral-specific T cells (VSTs) under emergency investigational new drug applications to 6 immunocompromised patients with persistent coronavirus disease 2019 (COVID-19) and characterized clinical and virologic responses. Three patients had partial responses after failing other therapies but then died. Two patients completely recovered, but the role of VSTs in recovery was unclear due to concomitant use of other antivirals. One patient had not responded to 2 courses of remdesivir and experienced sustained recovery after VST administration. The use of VSTs in immunocompromised patients with persistent COVID-19 requires further study.

ALVR109, an off-the-shelf partially HLA matched SARS-CoV-2-specific T cell therapy, to treat refractory severe COVID-19 pneumonia in a heart transplant patient: Case report.

An unvaccinated adult male heart transplant recipient patient with recalcitrant COVID-19 due to SARS-CoV-2 delta variant with rising nasopharyngeal quantitative viral load was successfully treated with ALVR109, an off-the-shelf SARS-CoV-2-specific T cell therapy. Background immunosuppression included 0.1 mg/kg prednisone, tacrolimus, and mycophenolate mofetil 1 gm twice daily for historical antibody-mediated rejection. Prior therapies included remdesivir, corticosteroids, and tocilizumab, with requirement for high-flow nasal oxygen. Lack of clinical improvement and acutely rising nasopharyngeal viral RNA more than 3 weeks into illness prompted the request of ALVR109 through an emergency IND. The day following the first ALVR109 infusion, the patient's nasopharyngeal SARS-CoV-2 RNA declined from 7.43 to 5.02 log10 RNA copies/ml. On post-infusion day 4, the patient transitioned to low-flow oxygen. Two subsequent infusions of ALVR109 were administered 10 and 26 days after the first; nasopharyngeal SARS-CoV-2 RNA became undetectable on Day 11, and he was discharged the following day on low-flow oxygen 5 weeks after the initial diagnosis of COVID-19. The clinical and virologic improvements observed in this patient following administration of ALVR109 suggest a potential benefit that warrants further exploration in clinical trials.

Office practice-based confirmation of onychomycosis: a US nationwide prospective survey.

BACKGROUND: Onychomycosis is sufficiently prevalent to be seen and treated by primary care physicians. The diagnosis of onychomycosis is most often confirmed from nail specimens by microscopy and fungal culture done at a central laboratory; these are relatively expensive tests with a turnaround time of a month or more. This study was conducted (1) to evaluate the use of in-office dermatophyte test medium (DTM) culture, and (2) to determine the epidemiology of onychomycosis in a large, nationwide sample of patients who were not participants in a clinical trial. METHODS: A nationwide sample of primary care physicians and podiatrists enrolled 670 patients with clinical signs of toenail onychomycosis. Dermatophyte test medium cultures were performed in the office and the results were compared with fungal cultures performed by a central laboratory. RESULTS: Central laboratory fungal cultures were positive in 44% (n = 297) of patients and DTM cultures in 51% (n = 345). Dermatophytes accounted for 93% of the confirmed infections and nondermatophyte molds the rest. In the 617 patients with paired dermatophyte test medium and laboratory fungal culture results, the 2 tests were in agreement (both positive or both negative) in 68% of cases (kappa, 0.37; asymptotic SE, 0.04; 95% confidence interval, 0.299-0.441). CONCLUSIONS: A DTM culture is a relatively rapid, easy, and inexpensive method to confirm dermatophyte infections in patients with signs of onychomycosis in the primary care setting. Because the available drugs for treating onychomycosis are effective against all dermatophyte species, the confirmation of dermatophyte infection, without further identification of genus and species, is sufficient evidence to begin treatment.

Dermatophyte test medium culture for evaluating toenail infections in patients with diabetes.

OBJECTIVE: To evaluate the performance of the in-office dermatophyte test medium (DTM) culture when used to confirm the diagnosis of onychomycosis in diabetic patients. RESEARCH DESIGN AND METHODS: Nail samples from 184 diabetic patients who exhibited symptoms consistent with toenail onychomycosis were screened for dermatophyte fungal infection using DTM, potassium hydroxide evaluation, and central mycology laboratory culture tests. The diabetic patient group investigated in this study is a subset of a heterogeneous set of patients who participated in a nationwide survey designed to investigate the use of fungal culture tests by dermatologists, podiatrists, and primary care physicians described in detail elsewhere. The overall sensitivity of the DTM and central laboratory culture methods was estimated and compared. Sensitivity differences between DTM and central laboratory culture methods were tested for statistical significance using the McNemar statistic. RESULTS: DTM culture was positive in 102 of 184 patients (55%), while the central laboratory culture test detected the existence of fungal infection in 78 of 184 (42%). The two tests were in agreement (both positive or both negative) in 114 of 184 patients (62%). Central laboratory culture identified dermatophytes as the pathogen in 91% of positive cases. CONCLUSIONS: DTM is a convenient and inexpensive culture test that can be used to confirm dermatophyte infections in diabetic patients with presumed onychomycosis. We found this test to be well suited for use in the primary care setting. Because oral antifungal agents are effective against dermatophyte species, which cause the vast majority of nail infections, diagnosis of onychomycosis requires confirmation of dermatophyte infection only, not identification of genus and species. DTM fulfills this requirement and has a diagnostic yield comparable to central laboratory culture.

Seguridad del tratamiento con terbinafina enpacientes mayores de sesenta años: estudio multicéntrico sobre onicomicosis del pie / The safety of terbinafine in patients over the age of 60 years: a multicenter trial in onychomycosis of the feet

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