Micafungin for Candida infections in Slovenia and Romania: A multicenter, observational, prospective study.

INTRODUCTION: An echinocandin, such as micafungin, is recommended as first-line treatment for invasive Candida infections in immunocompromised patients. This multicenter, observational, prospective, non- interventional study evaluated the real-world use of micafungin in clinical practice in Slovenia and Romania, as this remains unexplored. METHODOLOGY: The primary endpoint was evaluation of micafungin use, including rationale for prescription, treatment duration, and daily dose. Secondary endpoints included recordings of patient baseline characteristics and evaluations of efficacy and safety. Across 11 centers in two countries, 118 patients (18 children [< 16 years] and 100 adults [≥ 16 years]) received micafungin for the first time according to their clinic's standard practice. RESULTS: Micafungin was prescribed for treatment in 57.6% of patients and for prophylaxis in 40.7% of patients. The median (range) treatment duration was 9.0 (0 - 54) days and 13.0 (2 - 6)] days, respectively. The median dose of micafungin was higher than recommended for children receiving prophylaxis or treatment for invasive candidiasis and for adults receiving prophylaxis. Fever was the most commonly observed clinical sign at baseline (16 children [88.9%] and 31 adults [31%]) and hematologic malignancy was the most frequent primary diagnosis at admission (11 children [61.1%] and 40 adults [40%]). Candida species were the most commonly identified causal agents of invasive fungal infections (2 children [11.1%] and 48 adults [48%]). CONCLUSIONS: The efficacy and safety profiles of micafungin use in Slovenia and Romania based on clinician's own experiences in local clinical practice were consistent with those reported in other real-world studies.

Prophylactic versus clinically-driven antibiotics in comatose survivors of out-of-hospital cardiac arrest-A randomized pilot study.

AIM: To investigate benefits of prophylactic antibiotics in comatose survivors of out-of-hospital cardiac arrest (OHCA). METHODS: Patients without evidence of tracheobronchial aspiration on admission bronchoscopy were randomized to prophylactic Amoxicillin-Clavulanic acid 1.2g every 8h (P) or clinically-driven antibiotics (C) administered if signs of infection developed during initial 7days of intensive care unit (ICU) stay. RESULTS: Among 83 patients enrolled between September 2013 and February 2015, tracheobronchial aspiration was documented in 23 (28%). Accordingly, 60 patients were randomized. Percentage of patients on antibiotics between days 1-5 was significantly greater in P group. White blood count, C-reactive protein, procalcitonin (PCT) and CD 64 significantly increased during the postresuscitation phase. Except for lower CRP and PCT in group P on day 6 (p<0.05), there was no significant differences. Mini BAL on day 3 was less often positive in group P (7% vs. 42%; p<0.01). There was no significant difference in other microbiological samples and X-ray signs of pneumonia cumulatively documented in 50% in both groups. Use of vasopressors/inotropes (93% in both groups), duration of mechanical ventilation (5.4±3.7 vs. 5.2±3.1 days), tracheal intubation (6.5±4.6 vs. 5.9±4.3 days), ICU stay (7.7±5.2 vs. 6.9±4.5 days), survival (73% vs. 73%) and survival with good neurological outcome (50% vs. 40%) were also comparable between P and C groups. CONCLUSION: Bronchoscopy on admission documented tracheobronchial aspiration in 28% of comatose survivors of OHCA. In the absence of aspiration, prophylactic antibiotics did not significantly alter systemic inflammatory response, postresuscitation pneumonia, ICU treatment and outcome (ClinicalTrials.gov Identifier: NCT02899507).