S. Noviello

Outpatient parenteral antibiotic therapy for bone and joint infections : An italian multicenter study

Abstract In the early eighties, the advantages of outpatient parenteral antibiotic therapy (OPAT) (reduced costs, no hospitalization trauma in children, no immobilization syndrome in elderly, reduction in nosocomial infections by multiresistant organisms) were identified in the United States, and suitable therapeutic programs were established. Currently, more than 250,000 patients per year are treated according to an OPAT program. In order to understand the different ways of managing OPAT and its results, a National OPAT Registry was set up in 2003 in Italy. Analysis of data concerning osteomyelitis, septic arthritis, prosthetic joint infection and spondylodiskitis, allowed information to be acquired about 239 cases of bone and joint infections, with particular concern to demographics, therapeutic management, clinical response, and possible side effects. Combination therapy was the first-line choice in 66.9% of cases and frequently intravenous antibiotics were combined with oral ones. Teicoplanin (38%) and ceftriaxone (14.7%), whose pharmacokinetic/pharmacodynamic properties permit once-a-day administration, were the two top antibiotics chosen; fluoroquinolones (ciprofloxacin and levofloxacin) were the most frequently utilized oral drugs. Clinical success, as well as patients and doctors satisfaction with the OPAT regimen was high. Side-effects were mild and occurred in 11% of cases. These data confirm that the management of bone and joint infections in an outpatient setting is suitable, effective and safe.

Outpatient parenteral antibiotic therapy in the elderly: an Italian observational multicenter study

Abstract Bacterial infections are the most frequent cause of hospitalization in elderly patients. In the early eighties, the advantages of Outpatient parenteral Antibiotic therapy (OPAT) were identified in the United States, and suitable therapeutic programs were established. In order to understand the different ways of managing OPAT, a National OPAT Registry was set up in 2003 in Italy. This study analyzes data concerning bacterial infections in 176 elderly patients including demographics, therapeutic management, clinical response, and side-effects. Bone and joint infections (48.9%) and skin and soft tissue infections (27.8%) were the most common infections treated with OPAT. Teicoplanin (28.9%) and ceftriaxone (22.1%) were the top two antibiotics chosen. OPAT was mainly performed at a hospital infusion center (52.8%). The clinical success rate was high and side-effects were low (12.6% of cases). Management of bacterial infections in the elderly with an outpatient program is effective and safe.

Foot infections in diabetes (DFIs) in the out-patient setting: an Italian multicentre observational survey

Aimsu2003 To conduct a multicentre observational study to describe management of foot infections in diabetes in the out‐patient setting in Italy.

Antibiotic Prophylaxis in Hernia Repair and Breast Surgery: A Prospective Randomized Study Comparing Piperacillin/Tazobactam Versus Placebo

Abstract Although antibiotic prophylaxis is not explicitly indicated for hernia repair and breast surgery, its use for these clean procedures is widely adopted, albeit to a different extent in different countries, often on the personal decision of the individual surgeon. The present study was carried out to compare the efficacy of a single pre-operative dose of piperacillin-tazobactam with placebo in preventing surgical wound infections and to determine the main risk factors associated with infections following two main elective surgical clean procedures such as hernia repair and breast surgery. A total of 501 patients undergoing elective inguinal/femoral hernia repair or breast surgery were enrolled in this prospective randomized clinical study. Patients were randomly assigned to receive preoperative antibiotic prophylaxis or placebo. One dose of piperacillin-tazobactam 2.250 g or placebo was administered i.v. 30 minutes prior to the surgical procedure. Using statistical univariate analysis, the following variables were correlated with a higher infection risk: age >40 years, concomitant disease, WBC <3500, surgical wound size >9cm, use of drainages, non-prophylaxis. Using multivariate analysis, no antibiotic pre-operative prophylaxis, concurrent chronic diseases, especially diabetes (risk 15 times higher), and length of intervention >45 min (risk 6 times higher) were independent predictors of infection. Finally, patients with postoperative infections had a significantly longer hospitalisation. One pre-operative dose of piperacillin-tazobactam 2.250 g is more effective than placebo in preventing postoperative infections in breast surgery and hernia repair.

In Vitro Activity of Tigecycline: MICs, MBCs, Time-Kill Curves and Post-Antibiotic Effect

Abstract The minimum inhibitory concentrations (MICs), minimum bactericidal concentrations (MBCs), time-kill curves, and postantibiotic effect (PAE) of tigecycline, the first in the glycylcycline class of antibiotics, were evaluated. MICs were determined against 749 clinical isolates. Time-kill curves were performed against two isolates each of Enterococcus faecalis, MSSA, and MRSA. The presence of PAE, against the same isolates, was investigated. MIC90s (μg/mL) were the following: Escherichia coli 0.25; Klebsiella spp 0.5; Enterobacter spp 1; Acinetobacter spp. 2; Staphylococcus aureus (MSSA+MRSA) 0.25; CNS (MS+MR) 0.25; vancomycin-susceptible Enterococcus faecalis 0.12. Tigecycline exerted bacteriostatic activity against all the tested isolates, MBC90 values being 32×MIC. Time-kill experiments showed a marked reduction in bacterial growth. A PAE at 1- to 20-fold the MIC was observed against the two enterococcal isolates (1.5-3.2h, range) and the four staphylococci (1.6-3h, range). Our findings confirm the excellent antimicrobial activity of tigecycline, adding in-formation on its bacteriostatic activity vs enterococci and staphylococci, whether methicillin-resistant or -susceptible, and its PAE.

A pilot study on prevention of catheter-related urinary tract infections with fluoroquinolones

Abstract The objective of this multicenter, randomized, controlled, parallel group trial was to evaluate the efficacy of levofloxacin 250 mg oral, once daily (LVFX), placebo one tablet oral once daily (Placebo [P] group) and ciprofloxacin (CPFX) 500 mg oral, twice daily (single blind), prophylaxis in preventing bacteriuria (≤103 CFU/ml) in post-surgical catheterized patients. In the modified intention-to-treat (M-ITT) population of the 82 enrolled patients, negative bacteriuria was observed in 92% of LVFX group, in 80% of P group and in 100% of CPFX group while in the per-protocol (PP) population figures were: 100%, 86.4% and 100% respectively. Only one symptomatic urinary tract infection and one surgical wound infection were observed in the P group. Both drugs were well tolerated, showing a safety profile comparable to placebo. The high frequency of negative bacteriuria in the placebo group sounds encouraging as it underlines that the adoption of closed urinary drainage system catheters in hospital setting may reduce the frequency of hospital-acquired infections.

Short-course therapy with cefaclor for treatment of streptococcal pharyngotonsillitis.

Short-course treatments for streptococcal pharyngotonsillitis with oral cephalosporins or macrolides have resulted in a similar bacteriological and clinical cure rate and better compliance compared with the conventional 10-day course. One hundred and thirty eight of 420 recruited patients had a positive culture for Streptococcus pyogenes and were randomly assigned to receive cefaclor (25 mg/kg/bid) for a 5-day (70 patients) or 10-day (68 patients) course. Patients were assessed clinically and bacteriologically 2-3 days after completing the course and followed up after 20-30 days. All 420 recruited patients belonged to a population of 2800 children who had been previously screened for a streptococcal carrier state to exclude carriers from final evaluation. Clinical cure and bacterial eradication was recorded in 92.8 and 92.6% of patients in groups A and B, respectively. Therefore, short-course therapy with cefaclor may offer an effective alternative treatment to conventional regimens, with potential for better compliance.

Treatment options for skin and soft tissue infections caused by meticillin-resistant Staphylococcus aureus: oral vs. parenteral; home vs. hospital

Although meticillin-resistant Staphylococcus aureus (MRSA) is recognized as a significant cause of nosocomial infections, it is also becoming an increasingly common cause of infections in the community. Overall, the most common infections caused by MRSA are those involving the skin and skin structures. These infections are difficult to treat and are associated with high morbidity and substantial cost. This article summarizes the current oral and parenteral therapeutic options, of which there are several, and the optimal site of care for the management of these infections. Defining the severity of the illness is central to improving the decision-making process about the route of administration and site of care.

Ceftazidime for Outpatient Parenteral Antibiotic Therapy (OPAT) of Chronic Suppurative Otitis Media Due to Pseudomonas aeruginosa

Abstract The number of patients receiving parenteral antibiotic therapy outside the hospital (OPAT) is growing rapidly, not only because of financial considerations, but also to limit the risk of nosocomial infections, hospitalization trauma, and to improve the quality of life. The same benefits of OPAT have recently been extended to pediatric patients. In the present study, the efficacy and safety of OPAT was evaluated in 52 children (age range 6-12 years) affected by chronic suppurative otitis media (CSOM) whose parents were deemed compliant. Otorhinolaryngologists and infectious disease specialists (IDS) cooperated in diagnosing, managing patients and being available 24 hours a day for family consultation. Bacteriological examination of ear exudate was carried out before antibiotic treatment. For all 52 children the infection was caused by Pseudomonas aeruginosa in vitro sensitive to ceftazidime. Ceftazidime was administered at the dosage of 500 mg b.i.d. i.m. at the patients home according to a self administration model for 7-10 days. All patients returned every other day during the treatment course for clinical observation and cleansing of the ear, and 30 days after the end of the treatment (follow-up). Complete clinical cure and bacteriological eradication were observed in 35 patients (67%), clinical improvement in 12 (23%). No side-effects or hearing impairment were reported at clinical and audiometric check-ups; compliance was absolute. Our data suggest that children affected by CSOM can be managed as outpatients by a cooperative team of otorhinolaryngologists and IDS.

Clinical Efficacy and Tolerability of Levofloxacin in Patients with Liver Disease: A Prospective, Non Comparative, Observational Study

Abstract The aim of this open, non comparative, observational study was to assess the clinical and bacteriological efficacy, the tolerability and safety of levofloxacin for treatment of concurrent bacterial infections in patients with chronic liver disease. Overall, 40 patients (inpatients or outpatients) were recruited to the study (28 with UTI, 6 with pneumonia, and 6 with spontaneous bacterial peritonitis (SBP)). Patients affected by UTI received 250 mg oral levofloxacin once daily for five days; patients with pneumonia or SBP underwent a 10/14-day therapeutic oral regimen with 500 mg b.i.d. Clinical evaluation and possible side effects were monitored daily both in out- and in-patients. For all patients, laboratory tests were performed at baseline and 3-4 days after the end of therapy in order to evaluate levofloxacin tolerability. Statistical analysis was performed by means of Students t test to show differences between cases; all values are reported as means and standard deviations and p values were considered as significant when p<0.05. After treatment, clinical cure and bacteriological eradication were achieved in all patients (40/40; 100%). Adverse events, mainly gastrointestinal disturbances (e.g. nausea), were observed in 5 out of 40 patients (12.5%) and no neurotoxic effects were registered (e.g. anxiety, hallucinations, convulsions, mental confusion). No significant variation in laboratory tests due to hematic crasis and/or hepatic and renal disorders was observed. Levofloxacin proved to be highly efficacious and safe in the treatment of bacterial infections in patients affected by liver disease.