This case series of M. abscessus infection in US "lipotourists" highlights the risks of traveling abroad for surgery and the potential role of the Internet in identifying and investigating outbreaks.
Background/aims
The Food and Drug Administration recommends research into developing well-defined and reliable endpoints to evaluate treatments for severe influenza requiring hospitalization. A novel 6-category ordinal endpoint of patient health status after 7 days that ranges from death to hospital discharge with resumption of normal activities is being used in a randomized placebo-controlled trial of intravenous immunoglobulin (IVIG) for severe influenza (FLU-IVIG). We compare the power of the ordinal endpoint under a proportional odds model to other types of endpoints as a function of various trial parameters.
Methods
We used closed-form analysis and empirical simulation to compare the power of the ordinal endpoint to time-to-event, longitudinal, and binary endpoints. In the simulation setting, we varied the treatment effect and the distribution of the placebo group across the follow-up period with consideration of adjustment for baseline health status.
Results
In the analytic setting, ordinal endpoints of high granularity provided greater power than time-to-event endpoints when most patients in the placebo group had either naturally progressed to the category of hospital discharge by day 7 or were far from hospital discharge on day 7. In the simulation setting, adjustment for baseline health status universally raised power for the proportional odds model. Across different placebo group distributions of the ordinal endpoint regardless of adjustment for baseline health status, only time-to-event endpoints yielded higher power than the ordinal endpoint for certain treatment effects.
Conclusions
In this case study, the FLU-IVIG ordinal endpoint provided greater power than time-to-event, binary, and longitudinal endpoints for most scenarios of the treatment effect and placebo group distribution, including the target population studied for FLU-IVIG. The ordinal endpoint was only surpassed by the time-to-event endpoint when many patients in the placebo group were on the cusp of hospital discharge on day 7 and the follow-up period for the time-to-event endpoint was extended to allow for additional events. Our general approach for evaluating the power of several potential endpoints for an influenza trial can be used for designing other influenza trials with different target populations and for other trials in other disease areas.
Influenza infection most commonly affects the upper and lower respiratory tracts, but can involve extrapulmonary sites, including the myocardium. We report on a case of myocarditis caused by documented 2009 pandemic H1N1 influenza in a previously healthy adult, and review the literature on influenza myocarditis.
Lactobacillus species are facultative gram-positive, catalasenegative anaerobic bacilli that are part of the normal bacterial flora of the human gastrointestinal mucosa. They are rarely considered a pathogen but have been reported to cause bacteremia with or without endocarditis among other infections including vertebral osteomyelitis, liver or pelvic abscesses, meningitis, and pneumonia. They can cause disease in patients who are immunocompetent and immunocompromised. Recommended treatment of choice for severe infections due to Lactobacillus species endocarditis is high-dose penicillin in combination with an aminoglycoside.
Background:
The significance of Candida in pulmonary secretions is unclear, and usually is regarded as colonization, not contributing to symptoms or disease. Yet, in our experience, Candida seemed associated with chronic sputum, mucus plugging, atelectasis, and poor outcome.
Objective:
The aim of this study is to describe the clinical findings of patients with Candida in pulmonary (sputum or bronchoscopy) secretions and the significance of Candida.
Methods:
Retrospective study of inpatients and outpatients referred for pulmonary consultation with Candida in pulmonary secretions. Clinical parameters and estimates of whether Candida was likely clinically significant, were determined.
Results:
82 inpatients and 11 outpatients were identified, of which 61 (66%) had atelectasis and 68 (73%) bronchoscopies. Of patients having bronchoscopies, 56 (82%) had mucus, and 43 (63%) mucus plugging. Of the inpatients death (or probable death) occurred in 43 (63%), 42 (98%) of which were from definite or probable respiratory failure, with 13 (31%) likely related to mucus plugging, 16 (38%) possibly from mucus plugging, 6 (14%) unknown, and 7 (17%) not due to mucus plugging. Candida was felt likely clinically significant in 57 patients (61%), uncertain significance in 23 (25%), and not significant in 13 (14%). All outpatients had exacerbations, including 7 (64%) within a year.
Conclusion:
Patients requiring pulmonary consultation with Candida in pulmonary secretions often have chronic sputum production, exacerbations, mucus plugging, atelectasis, and death from respiratory failure. Candida was likely clinically significant in most patients. Recommendations to consider Candida in pulmonary secretions as colonization should be reconsidered.
Infections due to community-associated methicillin---resistant Staphylococcus aureus (CA-MRSA) are becoming more prevalent. CA-MRSA infections have unique epidemiologic features and virulence factors. Compared with health care-associated MRSA (HA-MRSA), most CA-MRSA is clonal type USA300 or 400 and has the Staphylococcal cassette chromosome mec type IV, which carries the mecA gene that encodes for resistance to methicillin and other beta-lactam antibiotics but generally not for other antibiotics. CA-MRSA often contains various virulence factors that may result in tissue necrosis. CA-MRSA clinical presentation includes mostly skin and soft tissue infections and less frequently pneumonia. In many of the small soft tissue abscesses due to CA-MRSA, primary treatment with surgical drainage may result in improvement without antibiotic therapy. Optimal treatment and prevention of CA-MRSA infections are unclear. However, distinction between CA-MRSA and HA-MRSA may be less relevant in the future, as CA-MRSA strains are now diagnosed in the hospital setting.
Remediation of struggling learners is a challenge faced by all educators. In recognition of this reality, and in light of contemporary challenges facing infectious diseases (ID) fellowship program directors, the Infectious Diseases Society of America Training Program Directors’ Committee focused the 2018 National Fellowship Program Directors’ Meeting at IDWeek on “Remediation of the Struggling Fellow.” Small group discussions addressed 7 core topics, including feedback and evaluations, performance management and remediation, knowledge deficits, fellow well-being, efficiency and time management, teaching skills, and career development. This manuscript synthesizes those discussions around a competency-based framework to provide program directors and other educators with a roadmap for addressing common contemporary remediation challenges.
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