Prevalence and risk factors for nosocomial infections in hospitals of the Veneto region, north-eastern Italy.

OBJECTIVE: The study aimed to assess prevalence and risk factors for nosocomial infection (NI) in 21 hospitals of the Veneto Region (Italy). METHODS: In May 2003, a one-week-period prevalence study of NI was carried out in 21 hospitals, representing 63% of all hospital beds for acute patients of the Veneto Region. Intensive care units represented 84% of all intensive care beds of the Region. Long term care, neonatal intensive care, burn, psychiatric and dermatology units were excluded. RESULTS: Overall, 6,352 patients were surveyed. The prevalence of NI was 7.6% (range 2.6%-17.7%), while 6.9% of patients (range 2.6%-15.5%) were affected by at least one NI. The prevalence of patients with NI in medical, surgical and intensive care areas was 6.6%, 5.0% and 25.8%, respectively. The sites most frequently affected were the following: urinary tract (28.4%), surgical site (20.3%), blood stream (19.3%), pulmonary and lower respiratory tract (17.6%). At multivariate analysis risk factors independently associated to NI were: Charlson index score >1, severity of underlying disease, exposure to antibiotics, surgical intervention, trauma at admission, presence of central venous catheter >24 h, urinary catheter, intubation, tracheostomy, and duration since admission >15 days. CONCLUSION: The study provided baseline data of NI in the Veneto Region hospitals. It showed that NI are frequent, and display a wide inter-hospital variability of rates. The highest prevalence has been reported in intensive care units. The unusual high frequency of blood stream infections and the relatively lower prevalence rate of surgical site infections highlighted the limits of prevalence studies.

Linkage of microbiology reports and hospital discharge diagnoses for surveillance of surgical site infections.

Surveillance of surgical site infections (SSIs) with feedback to surgical personnel is pivotal in decisions regarding infection control. Prospective surveillance is time and resource consuming, so we aimed to evaluate a method based on data collected routinely during care delivery. The study was carried out at three acute hospitals in North-eastern Italy, from 1 January 2001 to 31 December 2001. Hospital discharge diagnoses (selected codes from the International Classification of Diseases, 9th Revision--Clinical Modification) and electronic microbiology reports (positive cultures from surgical wounds and drainages) were linked to identify suspected SSIs. A random sample of tracked events was submitted to total chart review in order to confirm the presence of SSIs retrospectively according to Centers for Disease Control and Prevention definitions. Of 865 suspected SSIs, 64.5% were identified from the microbiological database, 27.1% from discharge codes, and 8.4% from both. Four hundred and three admissions were sampled for review; the overall positive predictive value was 72% (95%CI=69-76%). Since inpatient individual antibiotic exposure is not registered in Italy, the combined use of discharge codes and microbiology reports represents the most feasible automated method for surveillance of SSIs developing during hospital stay.

Predictors of protease inhibitor-associated adverse events.

Risk factors in the development of adverse reactions in HIV-1-infected patients treated with highly active antiretroviral therapy (HAART) containing protease inhibitors are poorly understood. To identify predictors of protease inhibitor-associated adverse events, we are conducting a prospective, cohort, multicenter study on HIV-positive patients starting treatment with at least one protease inhibitor. Rate ratios (RR) of adverse events were calculated, and logistic regression was used to adjust simultaneously for the potentially confounding effects of selected variables, according to the Cox model. A total of 1477 patients have been enrolled up to April 2000, having an average age of 37.1 years (SD +/- 8.1); 1066 (72.2%) were male. Where risk factors for HIV infection are concerned, the distribution was as follows: 48.1% intravenous drug users, 31.6% heterosexual contacts, 16.2% homosexual males and 0.7% blood transfusion. Average CD4+ lymphocyte count at enrollment was 265 cells/mmc (SD +/- 201). Average follow-up time is equal to 17.8 months (range 1-32). The risk of developing adverse reactions is significantly increased in female patients, older patients, hemophiliac subjects and in subjects with hepatitis. Patients treated with ritonavir, the association ritonavir-saquinavir HGC, stavudine and efavirenz have significantly increased incidence of adverse reactions in PI-containing regimens; conversely, saquinavir HGC, zidovudine and lamivudine use was associated with a lower risk of developing adverse reactions.

Incidence of adverse reactions in HIV patients treated with protease inhibitors: a cohort study. Coordinamento Italiano Studio Allergia e Infezione da HIV (CISAI) Group.

OBJECTIVE: To assess the probability that protease inhibitor (PI) therapy might be discontinued because of adverse events (AE) and to evaluate the incidence rate of adverse reactions during PI treatment. DESIGN: A prospective cohort, multicenter study on HIV-positive patients starting treatment with at least one PI. SETTING: Ten departments of infectious diseases in Northern Italy. PATIENTS: A total of 1207 patients who started PI therapy in September 1997 and were consecutively observed up to April 1999. MAIN OUTCOME MEASURES: Adverse reactions following initiation of PI therapy, and time to therapy discontinuation due to AE. RESULTS: During the study period, 35.9% patients presented adverse reactions of any grade, whereas 9.7% presented at least one serious AE. After 12 months of treatment, the percentage of patients who had interrupted treatment was 36% of ritonavir-treated patients, 14.2% of those treated with indinavir, 13.6% of ritonavir-saquinavir hard gel capsules (HGC)-treated patients, and 8.5% and 2.1%, respectively, for those treated with nelfinavir and saquinavir HGC. Women and patients with hepatitis experienced a significantly greater number of adverse events compared with other categories. Gastrointestinal events were more frequently observed in patients treated with either ritonavir alone or in combination with saquinavir HGC, as well as in patients receiving nelfinavir, although in this group serious events were rare. Here again, neurologic, metabolic, and hepatic toxicity occurred more frequently in ritonavir and ritonavir-saquinavir HGC treated patients. Allergic reactions were more often observed in patients receiving nelfinavir. Indinavir-treated patients presented the highest incidence of renal toxicity. CONCLUSION: Ritonavir is the drug associated with the largest number of reactions, which appear during the first few months of treatment. Saquinavir HGC and nelfinavir are the best tolerated drugs in a clinical setting.

[Causality relationship of drug adverse reactions: experience in the use of HIV-protease inhibitors]. / Relazione di causalità delle reazioni avverse a farmaci: un'esperienza nell'utilizzo degli inhibitori della proteasi di HIV.

PURPOSE: To establish the exact cause and effect relationship between protease inhibitors (PIs) and adverse events. MATERIALS AND METHOD: Prospective, cohort, multicenter study on HIV-positive patients who are beginning treatment with a PI. Causal relationships are evaluated using the RUCAM algorithm. RESULTS: Since the beginning of the study 1207 patients have been enrolled. Average time of observation is 10.7 months. To date, 784 adverse events have been observed, distributed as follows: excluded 3.8%, improbable 18.5%, possible 41.3%, probable 30.1%, and highly probable 6.3%. Saquinavir shows a statistically significant difference in the rate of non-correlated events with respect to other groups. CONCLUSIONS: Over 20% of adverse events during PI treatment are shown to be non-correlated to these drugs. Saquinavir shows the highest rate of non-correlated events.