Mifepristone in Italy: the case of a drug trapped between ethics and clinical practice

In Italy mifepristone is not yet marketed. Gynaecologists in our hospital asked to use this medication as a less traumatic method for voluntary abortions. We followed the standard procedure defined by the Italian Health Ministry (IMH) for purchasing drugs from abroad but encountered several unexpected barriers. Starting from this case, this paper is aimed at identifying these barriers which we found to be not only professional, but also ethical, religious and moral.     

Nosocomial infections: back to the future

The increasing rate of nosocomial infections seems to be related to the wider use of invasive procedures. Evaluation of the patient risk factors for infection, use of SIRS classification and knowledge of the setting care should be utilized for the diagnostic approach. The empiric antibiotic therapy should take in account the site of the infection (bacteremia, pneumonia, urinary tract infection etc.) and the presumed pathogen; knowledge of the local epidemiology is a pre-requisite for the antibiotics choice. Among gram-positive microorganisms, methicillin-resistant staphylococci and vancomycin-resistant enterococci are responsible of difficult to treat infections; penicillin-resistant pneumococci, largely present in some european countries, might become an emerging pathogen also in Italy. The knowledge and ability of infectious diseases specialist encompasses clinical, microbiological and epidemiological fields to play a key role in the prevention and management of nosocomial infections.     

Ceftriaxone versus aztreonam plus cefazolin for infections in cancer patients with adequate neutrophil counts

Summary In a prospective randomized trial, 154 febrile episodes in cancer patients with adequate neutrophil counts (>1,000 cells/mm³) were treated with either ceftriaxone (72 episodes) or aztreonam plus cefazolin (82 episodes). Documented infections represented almost half of the febrile episodes. The overall response rates among the 144 evaluable episodes were similar for the two regimens: 76% (51/67) with ceftriaxone versus 82% (63/77) with aztreonam plus cefazolin (p=0.41, not significant). Although not statistically significant, the response rate of the microbiologically documented infections was slightly better in patients treated with the double -lactam combination (85% vs. 65%, p=0.16) and clinically documented infections showed a better response in the group of patients receiving monotherapy (87% vs. 59%, p=0.12). No serious adverse effects were observed during this study and both regimens were well tolerated. Ceftriaxone or the combination of aztreonam plus cefazolin showed a similar efficacy as empirical therapy for infections in cancer patients with adequate neutrophil counts.

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Ceftriaxon im Vergleich zu Aztreonam plus Cefazolin zur Behandlung von Infektionen bei Krebspatienten mit adäquaten Neutrophilenzahlen

Zusammenfassung 154 Fieberschübe bei Krebspatienten mit adäquaten Neutrophilenzahlen (>1.000 Zellen/mm³) wurden in einer prospektiven randomisierten Studie entweder mit Ceftriaxon (72 Episoden) oder Aztreonam plus Cefazolin (82 Episoden) behandelt. Nahezu die Hälfte der fieberhaften Episoden waren dokumentierte Infektionen. Die Gesamtansprechrate bei den 144 auswertbaren Episoden war für beide Therapien ähnlich: 76% für Ceftriaxon (51/67) und 82% für Aztreonam plus Cefazolin (63/77) (p=0,41; nicht signifikant). Bei mikrobiologisch dokumentierten Infektionen war die Ansprechrate unter der Doppel-Betalaktam-Kombination etwas besser (85 % im Vergleich zu 65%; p=0,16), doch war dieser Unterschied nicht signifikant. Bei den klinisch dokumentierten Infektionen zeigten die mit der Monotherapie behandelten Patienten bessere Ansprechraten (87% gegenüber 59%; p=0,12). Während der Studie wurden keine ernsthaften Nebenwirkungen beobachtet, beide Therapien wurden gut vertragen. In der empirischen Therapie von Infektionen bei Krebspatienten mit adäquaten Neutrophilenzahlen erwiesen sich Ceftriaxon und die Kombination von Aztreonam plus Cefazolin als vergleichbar wirksam.

     

Worrisome Trend of New Multiple Mechanisms of Linezolid Resistance in Staphylococcal Clones Diffused in Italy

In order to assess the frequency of clinically relevant linezolid-resistant staphylococcal isolates, and the role of linezolid in maintaining and coselecting multiple resistance mechanisms (cfr, 23S rRNA, L3/L4 mutations), a prospective Italian study was performed from 2010 to 2011 to confirm the diffusion of three major multidrug-resistant clones (ST2, ST5, ST23).     

Tested communication strategies for providing information to patients in medical consultations: A scoping review and quality assessment of the literature

ObjectivesTo systematize the scientific knowledge of empirically tested strategies for verbally providing medical information in patient-physician consultations.MethodsA scoping review searching for terms related to physician, information, oral communication, and controlled study. Four pairs of reviewers screened articles. For each selected study, we assessed the quality and summarized aspects on participants, study, intervention, and outcomes. Information provision strategies were inductively classified by types and main categories.ResultsAfter screening 9422 articles, 39 were included. The methodological quality was moderate. We identified four differently used categories of strategies for providing information: cognitive aid (n = 13), persuasive (n = 8), relationship- (n = 3), and objectivity-oriented strategies (n = 4); plus, one “mixed” category (n = 11). Strategies were rarely theoretically derived.ConclusionsCurrent research of tested strategies for verbally providing medical information is marked by great heterogeneity in methods and outcomes, and lack of theory-driven approaches. The list of strategies could be used to analyse real life communication.Practice implicationsFindings may aid the harmonization of future efforts to develop empirically-based information provision strategies to be used in clinical and teaching settings.     

Ceftolozane/tazobactam for the treatment of serious Pseudomonas aeruginosa infections: a multicentre nationwide clinical experience

This study describes the largest clinical experience using ceftolozane/tazobactam (C/T) for different Pseudomonas aeruginosa infections. A retrospective study was performed at 22 hospitals in Italy (June 2016–March 2018). All adult patients treated with ≥4 days of C/T were enrolled. Successful clinical outcome was defined as complete resolution of clinical signs/symptoms related to P. aeruginosa infection and lack of microbiological evidence of infection. C/T treatment was documented in 101 patients with diverse infections, including nosocomial pneumonia (31.7%), acute bacterial skin and skin-structure infection (20.8%), complicated UTI (13.9%), complicated IAI (12.9%), bone infection (8.9%) and primary bacteraemia (5.9%). Over one-half of P. aeruginosa strains were XDR (50.5%), with 78.2% of isolates resistant to at least one carbapenem. C/T was used as first-line therapy in 39 patients (38.6%). When used as second-line or later, the most common reasons for discontinuation of previous antibiotics were in vitro resistance of P. aeruginosa and clinical failure of previous therapy. Concomitant antibiotics were reported in 35.6% of patients. C/T doses were 1.5 g q8h in 70 patients (69.3%) and 3 g q8h in 31 patients (30.7%); median duration of C/T therapy was 14 days. Overall clinical success was 83.2%. Significant lower success rates were observed in patients with sepsis or receiving continuous renal replacement therapy (CRRT). Mild adverse events were reported in only three patients. C/T demonstrated a favourable safety and tolerability profile regardless of the infection type. Clinicians should be aware of the risk of clinical failure with C/T therapy in septic patients receiving CRRT.     

Dual photoacoustic/ultrasound multi-parametric imaging from passion fruit-like nano-architectures

Ultrasound (US) imaging is a well-established diagnostic technique to image soft tissues in real time, while photoacoustic (PA) is an emerging imaging technique employed to collect molecular information. Integration of PA and US imaging provides complementary information enhancing diagnostic accuracy without employing ionizing radiations. The development of contrast agents able to combine PA and US features is pivotal to improve the significance of PAUS imaging and for PAUS-guided treatment of neoplasms. Here, we demonstrate in relevant ex-vivo models that disassembling passion fruit-like nano-architectures (pfNAs) can be employed in PAUS imaging. pfNAs are composed by silica nanocapsules comprising aggregates of commercial NIR-dyes-modified polymers and ultrasmall gold nanoparticles. The intrinsic US and PA features of pfNAs have been fully characterized and validated in tissue-mimicking materials and in ex vivo preparations. Moreover, the application of a multi-parametric approach has allowed the increase of information extrapolated from collected images for a fine texture analysis.