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Luigia Scudeller

Publications and source records attributed to Luigia Scudeller.

13 recordsLinked to original sources
PubMed2006

Surveillance of hospital-acquired infections: a model for settings with resource constraints.

BACKGROUND: Surveillance activities have been considered of paramount importance for effective infection control programs in health care organizations. OBJECTIVES: Our objective was to design a capture system able to assure surveillance of hospital-acquired infections (HAI) in acute hospitals with few resources devoted to infection control. METHODS: We performed 4 biweekly repeated prevalence studies to identify major HAI (urinary tract infections, surgical site infections, lower respiratory tract infection, bloodstream infections) as defined by the Centers for Disease Control and Prevention (CDC) criteria in 3 large hospitals in northeastern Italy (6 internal medicine departments, 5 general surgery departments, 3 intensive care units, and 1 bone marrow transplant unit). RESULTS: One thousand five hundred fifty-four patients were screened (63.9% in medical wards, 27.5% in surgical wards, and 8.5% in intensive care units and bone transplant unit). The overall prevalence of infection was 4.9% (77/1,554); 4.5% (70/1,554) of patients were infected. A capture system based on the presence of fever >or=38 degrees C, antibiotic use, and presence of devices guarantees 100% sensitivity in detecting HAI but requires an assessment of 62% of the population. Using the presence of fever and devices as criteria guarantees a sensitivity of 98%, requiring an assessment of 41.4% of patients, whereas presence of fever and antibiotic use has the same sensitivity but requires an assessment of 50% of patients. Using nursing records, physician records, and direct patient examination as sources of documentation guarantees that all necessary data are collected while requiring a mean of 4 minutes and 42 seconds per patient (standard deviation, 1 minute and 30 seconds). CONCLUSION: A capture system based on biweekly repeated prevalence studies that select patients for the presence of fever, antibiotics, and medical devices ensures the detection of all HAI in a resource-limited environment.

Aged↗
PubMed2006

Human granulocytic anaplasmosis in northeastern Italy.

Sporadic cases of human granulocytic anaplasmosis (HGA) have been reported in areas with a high prevalence of tick-borne diseases (TBDs) in Europe. We aimed at estimating the sero-prevalence of A. phagocytophilum and other TBDs in northeastern Italy in outpatients with a history of recent tick bite or suspected TBD. In the 1-year study, 79 patients were enrolled and 30 (38%) received a diagnosis of TBD: 24 (30%) with Lyme disease and 5 (6%) with HGE. Our findings indicate the presence of HGA in northeastern Italy; so, since co-infection with Lyme disease appeared to be frequent, physicians assessing patients after a tick bite should consider HGA in the diagnosis.

Anaplasmosis↗
PubMed2004

Selection of antiretroviral therapy guided by genotypic or phenotypic resistance testing: an open-label, randomized, multicenter study (PhenGen).

The phenotype/genotype (PhenGen) open-label, randomized, multicenter study evaluated the genotype/virtual phenotype (vPt) and real phenotype (rPt) for choosing a new highly active antiretroviral therapy regimen at failure. Patients with a plasma viral load (pVL) between 2000 and 200,000 copies/mL and a CD4 cell count >200/microL, failing > or =2 regimens (<6 drugs), were randomized for vPt or rPt. Three hundred three patients were enrolled: 111 and 108 patients received a new treatment in the vPt and rPt arms, respectively. The 2 groups were comparable for baseline patient characteristics and treatment history. The new therapy was in agreement with expert advice in 58.5% of cases. After 6 months, no statistical differences were found in the mean absolute change from baseline CD4 cells (+55 and +46 cells/muL; P = 0.7), mean pVL log decrease (-1.35 and -1.37; P = 0.8), or proportion of patients with a pVL <400 copies/mL (54.8% in vPt arm and 52.6% in rPt arm; P = 0.9). At multivariate analysis, variables independently associated with failure of the new regimen were: pVL at baseline (odds ratio [OR] = 1.81; P < 0.021), number of nucleoside reverse transcriptase inhibitor-associated mutations (OR = 1.21; P = 0.001), number of protease mutations (OR = 1.15; P < 0.001), and recycling of indinavir (OR = 4.63; P = 0.019). Patients' adherence to the prescribed regimen (OR = 0.23; P < 0.001), number of active drugs in the new regimen (OR = 0.55; P = 0.001), and adherence to expert advice (OR = 0.37; P < 0.001) predicted virologic response. The vPt is as predictive of treatment outcome as the rPT. Use of expert advice significantly improved the response to therapy.

Adult↗
PubMed2004

Linezolid disposition after standard dosages in critically ill patients undergoing continuous venovenous hemofiltration: a report of 2 cases.

Linezolid is a new oxazolidinone antibiotic active against most Gram-positive microorganisms the renal elimination of which accounts for about 30% to 35% of all the clearance. Its pharmacokinetic ability was assessed during continuous venovenous hemofiltration (CVVH) in 2 anuric patients with severe postsurgical intraabdominal infections who were receiving standard dosages (600 mg intravenously twice a day). Blood samples for quantification of linezolid in plasma and in filtrate were collected after more than 4 days of therapy before dosing and at 0, 0.5, 1, 2, 3, 5, 7, 9, and 11 hours after the morning 1-hour intravenous infusion, and concentrations were determined by means of high-performance liquid chromatography. Linezolid was partially cleared by CVVH in both the patients (hemofiltration clearance [CL CVVH ] = 0.38 and 0.35 mL/min/kg), with high sieving coefficient values (0.76 to 0.92). Efficacious plasma exposure for time-dependent antibacterial activity of linezolid, either in terms of trough levels above minimum inhibitory concentration (MIC) at which 90% of the isolates are inhibited (Cmin >MIC90 ) or of area under the plasma concentration time curve to MIC90 ratio (AUC/MIC90 ) >100 hours, was ensured during CVVH in both patients. However, despite similar CL CVVH , significant interindividual pharmacokinetic variability was found in the 2 patients (AUC during the observational period [AUC 0-tau ] 334.71 versus 109.34 mg/L x h), mainly owing to substantial differences in non-CVVH-related clearance of linezolid (total CL, 0.55 versus 1.21 mL/min/kg). Our findings indicate that linezolid, although partially removed, does not warrant dosage modification during the first 48 hours when CVVH (with polysulfide hemofilter) at standard 2,000 mL/h substitution flow rate in predilution is applied to anuric patients. Thereafter, this choice is a reasonable one with the exception of those patients who have other features of linezolid toxicity and in which non-CVVH-related clearance might be impaired, although further evaluations are warranted.

Acetamides↗
PubMed2004

Strategies to decrease viral load rebound, and prevent loss of CD4 and onset of resistance during structured treatment interruptions.

BACKGROUND: Toxicity and other drug adherence-related factors have contributed to decreased compliance to antiretroviral regimens amongst HIV-infected patients. Irregular therapy disruption causes loss of CD4 T cells, onset of drug resistance and rapid rebound of plasma viral load (VL). However, an appropriate choice of drugs and properly scheduled structured treatment interruptions (STIs) may limit VL rebound, maintain CD4 counts and minimize resistance. METHODS: We conducted a clinical study of STIs, RIGHT 901, involving 60 drug-naive patients with chronic HIV infection (CD4 >300, VL >10,000) randomized to receive didanosine-stavudine-indinavir (IDV group) or didanosine-stavudine-hydroxyurea (HU group), for 12 weeks. Subsequently, all patients were randomized again to start STI (short induction) or to continue the therapy for an additional 24 weeks before starting STI (long induction). Both groups underwent four STI cycles and then stopped therapy as long as viraemia remained below 10,000 copies/ml before reinitiating another four cycles of STI. RESULTS: During continuous therapy VLs were suppressed at similar rates in both the HU and IDV groups, while a blunted CD4 count was documented in the HU group. Following the first stop median VL rebounded close to baseline values in both groups, however, during the following STI median VL rebound decreased in the HU group, while in the IDV group VL continued to rebound to values close to baseline, and the difference between the two groups was statistically significant. Moreover, patients treated with HU had a constant and stable CD4 increase during STI, whereas CD4 counts fluctuated in the IDV group, with sharp falls during treatment interruptions and partial CD4 recovery following treatment restart. Even in the presence of IDV resistance predisposing mutations at baseline, no genotypic change in the protease sequence was observed during STI. A relevant mutation in the reverse transcriptase sequence (K70R) emerged in one patient interrupting treatment after 36 weeks of continuous therapy and in one patient after four STI cycles. Side effects (no major events) were similar among groups. CONCLUSIONS: An appropriate choice of STI schedule and regimens containing drugs less prone to resistance and/or able to prevent CD4 fluctuation may contribute to optimizing STI for chronically infected patients with respect to limiting viral rebound, improving CD4 counts and maintaining a resistance profile comparable to continuous highly active antiretroviral therapy.

Anti-HIV Agents↗
PubMed2003

HIV susceptibility to amprenavir: phenotype-based versus rules-based interpretations.

OBJECTIVES: The objective was to study genotypic correlates of discordant interpretations of amprenavir (APV) resistance between a rules-based algorithm and either recombinant phenotype or virtual phenotype. METHODS: HIV resistance mutations found in patients from the GenPheRex study were interpreted with VGI-TRUGENE (version 5.0; VGI) and compared with either recombinant-phenotype (Antivirogram, r-PHT) or virtual-phenotype (Virtual-Phenotype, v-PHT) interpreted through Virco biological cut-offs. RESULTS: Among 180 samples available, 56 (31.1%) were discordant with the observed genotype interpretation results, as a result of being judged as sensitive by r-PHT or v-PHT but resistant by VGI (S/R). Only the I84V mutation was almost invariably found in concordant resistant isolates compared with S/R isolates (60% versus 0%, respectively; P < 0.0001). Notwithstanding this, the number of multi-protease inhibitor-associated mutations (PAMs) was significantly higher in the concordant resistant isolates; the prevalence of >3 PAMs was 56.52% versus 33.93% in R/R and S/R isolates, respectively (P = 0.01). Correspondence analysis confirmed the relevance of PAMs, although additional mutations appeared to be correlated with APV resistance. CONCLUSIONS: The rate of discordance between rules-based and either r-PHT or v-PHT interpretations for APV was high. Mutation I84V and accumulation of >3 PAMs were found to be associated with resistance as interpreted with all systems tested. However, our results indicate that a number of mutations may have an impact on APV resistance, but that they are missed by current interpretation algorithms and this merits further investigations.

Algorithms↗
PubMed2003

HIV-1 phenotypic susceptibility to lopinavir (LPV) and genotypic analysis in LPV/r-naive subjects with prior protease inhibitor experience.

The relationship between phenotypic susceptibility to lopinavir (LPV) and genotypic pattern was investigated in LPV-naive, protease inhibitor (PI)-experienced subjects. Protease sequences of 100 HIV isolates with ascertained susceptibility (determined by Antivirogram) to LPV were analyzed (VircoGen). Two different thresholds (2.5- and 10-fold) were used for defining reduced susceptibility. Mutations were classified as LPV/r (the actual formulation of LPV that combines LPV with low-dose ritonavir) mutations according to the International AIDS Society-USA. Thirty-four isolates showed reduced LPV susceptibility (2.6- to 75.9-fold). Fold resistance to LPV correlated with the number of total and LPV/r mutations (Spearman coefficient = 0.62 and 0.74, respectively; P < 0.001). Current PI therapy (P = 0.002) and indinavir administration (P < 0.001), >5 LPV/r mutations (P < 0.0012), and detection of L10FIRV, K20MR, M46IL, I54VL, A71VT, G73SA, V82AFTS, I84V, and M90L were associated with LPV resistance in univariate analysis. Factors independently associated with LPV resistance were K20MR (odds ratio [OR], 13.9; 95% confidence interval [CI], 1.3-145.1; P = 0.028), I54VL (OR, 131.7; 95% CI, 10.5-1654.7; P < 0.001), G73SA (OR, 19.2; 95% CI, 1.4-273.7; P = 0.029), and I84V (OR, 177.5; 95% CI, 6.0-5232.5; P = 0.003) mutations and >9 protease mutations (OR, 18.6; 95% CI, 1.6-213.0; P = 0.019). Sixteen of 34 and 18 of 34 isolates with reduced LPV susceptibility showed >10-fold or <10-fold LPV resistance, respectively. Linear regression analysis demonstrated that each additional LPV mutation and I54VL accounted for much of the fold resistance to LPV (adjusted R2 = 0.70). In conclusion, for PI-experienced patients requiring salvage therapy, switching to LPV should be based on the number of baseline mutations and the presence of mutation 54.

Adult↗
PubMed2003

Comparison between rules-based human immunodeficiency virus type 1 genotype interpretations and real or virtual phenotype: concordance analysis and correlation with clinical outcome in heavily treated patients.

We compared 2 rules-based genotype interpretation systems and real or virtual phenotype through a retrospective analysis of a prospective trial. Genotypes were determined with VircoGEN II (VIRCO) and were interpreted with either RetroGram 1.4 or TRUGENE HIV-1 (guidelines 3.0) or original virtual phenotype (Virtual Phenotype; VIRCO), as available in the year 2000. Among 188 human immunodeficiency virus (HIV) type 1 isolates, overall concordance (kappa agreement) was observed for the 2 rules-based systems, whereas striking discordances were noted between them and real and virtual phenotype interpretations for stavudine, didanosine, zalcitabine, abacavir, and amprenavir (kappa<0.4). Clinical evaluation of a subset of 173 patients showed that both rules-based sensitivity scores were independently associated with HIV RNA loads <400 copies/mL at week 16 of during-treatment analysis (TRUGENE: odds ratio [OR], 2.90; 95% confidence interval [CI], 1.52-5.52; P=.001; RetroGram: OR, 2.34; 95% CI, 1.21-4.55; P=.012), whereas, in contrast to real or virtual phenotype, interpretations according to biological cut-offs were not (OR, 1.91; 95% CI, 0.77-4.76; P=.162).

Adult↗
PubMedDate not supplied

Access site-related infection in dialysis: the AStRID project: a multicenter prospective Italian study.

A multicenter prospective study has been planned, in a large sample of Italian end-stage renal disease (ESRD) patients, aiming to assess the vascular access (VA) site-related infection rates and to identify variables associated with them. All ESRD patients undergoing chronic hemodialysis (HD) in the participating centers will be enrolled in the study. Participating centers were selected on a voluntary basis. Patients will be enrolled within an 18-month recruitment period. Primary study end points are the overall incidence rate of VA-related infections in ESRD patients on chronic HD (defined as infection episodes/100 patient-months), and the incidence rate of different types of VA-related infections (exit site, tunnel and bacteraemia/sepsis). All VA types in use will be evaluated: fistula, graft, tunneled (permanent) central venous catheter (CVC) and temporary CVC.

Humans↗