Retrospective Analysis of the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTATM) Administered Under Enforcement Discretion to Patients With Clostridioides difficile Infection.

Background: Fecal microbiota, live-jslm (RBL; REBYOTA™), the first microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent recurrent Clostridioides difficile infection (rCDI) in adults, has been evaluated in 5 prospective clinical trials. A retrospective analysis considered the safety and efficacy of RBL administered under US Food and Drug Administration enforcement discretion to patients with rCDI and broad eligibility criteria mimicking real-world practice. Methods: We retrospectively identified adults with rCDI treated with RBL under enforcement discretion between November 1, 2015, and September 30, 2019, across 5 study sites. CDI diagnosis was based on site-specific practice. The primary safety set (PSS) included all patients who were naïve to previous RBL treatment and had continuously comprehensive medical records for 6 months following treatment. Results: The primary treatment cohort had 94 patients; the PSS included 64 patients with common comorbidities receiving diverse chronic therapeutics. Most treatment-emergent adverse events were mild to moderate in severity and comparable between comorbidity subgroups and the overall population. There were no serious adverse events related to RBL or the administration procedure. In the PSS, 82.8% of RBL-treated patients responded at 8 weeks, of whom 88.7% had sustained response through 6 months. The number of RBL doses administered had no marked effect on outcome. Conclusions: Together with prospective clinical trial outcomes, these findings support the efficacy and safety of RBL to prevent rCDI, with diagnostics and comorbidities representative of real-world clinical practice.

Missed Opportunities for HIV Diagnosis.

It has been previously shown that patients may present for multiple health issues in the years preceding their initial HIV diagnosis. This retrospective cohort study analyzed the data of patients with a new HIV diagnosis, at Ochsner Health System between January 1, 2011, and December 31, 2012. The primary end point was missed opportunities, the number of healthcare visits these patients made in the 2 years prior to being diagnosed with HIV. The 125 patients in the study cohort had 649 healthcare visits during which an HIV test was not performed. These missed opportunities are the key to capturing the undiagnosed and unaware HIV-positive individual. Primary care is an ideal setting to conduct HIV testing for those who have access to regular health care. However, nontraditional providers should also be encouraged to conduct HIV testing regardless of their ability to provide treatment because evidence shows that knowledge of the diagnosis may change behavior.

Implications of detecting the mold Syncephalastrum in clinical specimens of New Orleans residents after Hurricanes Katrina and Rita.

After the extensive flooding in New Orleans following Hurricanes Katrina and Rita, thousands of homes in the flooded areas had significant growth of mold. The potential health effects from exposures to these extraordinary environments are unknown. In February 2006, we investigated a cluster of patients with clinical specimens yielding Syncephalastrum, a zygomycete that rarely causes infection. We identified the cases of eight patients from September 12, 2005, to January 12, 2006, with specimens from sputum, bronchoalveolar lavage, endotracheal aspirate, ear swab, and nasal swab. All patients appeared to be transiently colonized without evidence of infection, even among immunosuppressed patients. Only one patient reported significant exposure to mold (working on mold remediation without wearing a respirator) on the day of his incident culture.

Primary cutaneous cryptococcosis in a lung transplant recipient.

Cryptococcal skin lesions are found in 10 to 15% of patients with disseminated cryptococcosis. Primary skin inoculation by Cryptococcus neoformans is rare but has been reported. We report the first known case of primary cutaneous cryptococcosis in a lung transplant recipient. Our patient, a 57-year-old man, underwent left single-lung transplantation and presented with a nonhealing ulcer 50 months later. Skin histopathology and culture confirmed C. neoformans. Serum and cerebrospinal fluid cryptococcal antigen tests were negative. The lesion healed after treatment with fluconazole. To date, disseminated disease is not evident. Primary cutaneous cryptococcosis has been reported in kidney and liver recipients but not in lung transplantation recipients. Nonhealing ulcers in immunocompromised patients mandate aggressive diagnostic procedures. Differential diagnosis of these cutaneous lesions should consider fungi, including C. neoformans.

Phaeohyphomycotic infections in solid organ transplant patients.

Phaeohyphomycoses are darkly pigmented fungi that rarely cause infection in immunocompetent persons. In the past 2 decades these fungi increasingly have been reported as pathogens that cause significant morbidity and mortality in the immunocompromised host, especially solid organ transplant recipients. Clinical manifestations range from superficial lesions to disseminated infections. Exophiala spp. and Alternaria spp. account for the great majority of these infections. Treatment should include complete surgical excision of the lesions that are accessible combined with antifungal therapy, especially when invasive or systemic infection is present. Itraconazole usually suffices if only subcutaneous lesions are present; however, if the infection is systemic or it involves the central nervous system, the addition of amphotericin B is required. New investigational azoles also should be considered in these types of infections. This is a very heterogenous group of fungi and as such the sensitivities to antifungal agents is variable. Therefore, sensitivities should be obtained on every fungal isolate.