High Altitude Illness: Knowledge, Practice, and Attitudes of Porters in Nepal.

INTRODUCTION: Porters working at high altitude face a number of preventable health risks ranging from frostbite to potentially fatal high-altitude pulmonary and cerebral edema. Porters are often recruited from impoverished low-altitude areas, poorly equipped in terms of protective clothing, and tasked with carrying loads that equal or exceed their body mass to high elevations. Despite a large population of porters working throughout mountainous parts of the world, there is little documentation regarding knowledge levels, attitudes, and practices related to the prevention of altitude illness in this population. Much of the literature focuses on biomechanics of load carrying for porters or altitude issues for trekkers. METHODS: A cross-sectional survey was developed using a modified Delphi technique. The survey was administered to a convenience sample of porters (n=146) from diverse cultural groups between Lukla (2774 m) and Everest Base Camp (5361 m). RESULTS: Many of the porters started at a young age, carried heavy loads, and had difficulty identifying symptoms of high altitude illness, and less than 20% correctly identified preventive measures for high-altitude illness. CONCLUSIONS: Porters in the Khumbu region continue to face hazards in their working environment. Future research and health education campaigns should address knowledge deficits and help with the design of tailored interventions.

Academy of Nutrition and Dietetics: Revised 2022 Standards of Practice and Standards of Professional Performance for Registered Dietitian Nutritionists (Competent, Proficient, and Expert) in Adult Weight Management.

A person's weight is an anthropometric measure factored into assessing health risk, not a measure of worth, ability, or overall health. Adult weight management is a spectrum of lifelong care services available for persons whose goals can be achieved through evidence-based, weight-related interventions and intersects most practice areas of nutrition. An adult weight management registered dietitian nutritionist (RDN) is responsible for providing a psychologically safe, accessible, and respectful setting and empowering care to those seeking nutrition services. This requires the RDN to act as an advocate by proactively seeking to identify personal and external weight biases, understanding the influence of those predispositions, and acknowledging how weight-related prejudices are intricately connected with systems that influence nutrition both inside and outside of health care. Increases in average weight influence potentially counterproductive discussions about judgment, an individual's body, and relationship with health. RDNs are equipped to provide dynamic care and be on the forefront of implementing weight-inclusive built environments, policies, and person-centered communications to minimize harm and maximize benefit for the individual and society. The authors, Weight Management Dietetic Practice Group, and the Academy of Nutrition and Dietetics Quality Management Committee revised the Standards of Practice and Standards of Professional Performance for RDNs in Adult Weight Management to update established criteria of competent practice, further define core values, and set direction for future areas of opportunity. The Adult Weight Management Standards of Practice and Standards of Professional Performance are complementary tools intended for RDNs to benchmark and identify progressive routes and goals for professional advancement.

Identification and pretherapy susceptibility of pathogens in patients with complicated urinary tract infection or acute pyelonephritis enrolled in a clinical study in the United States from November 2004 through April 2006.

OBJECTIVE: The purpose of this study was to assess the pretherapy microbiology and fluoroquinolone susceptibility of pathogens from 650 patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) as part of a multicenter, randomized, controlled clinical trial. METHODS: In this post hoc analysis of a multicenter, randomized, double-blind study, adults with a clinical diagnosis of cUTI or AP were recruited from 130 community-based and institution-based study centers in the United States from November 2004 through April 2006. Urine and blood culture specimens were identified and tested for susceptibility according to Clinical and Laboratory Standards Institute methods. Presence of a pathogen in the urine culture was confirmed by a colony count of =105 colony-forming units per milliliter. Susceptibility to nonstudy drugs (trimethoprim/sulfamethoxazole [TMP/SMX] and ampicillin) and to study drugs (levofloxacin and ciprofloxacin) was categorized as susceptible, intermediate, or resistant. RESULTS: Six hundred fifty patients (417 women, 233 men; age range, 18-94 years) with a diagnosis of cUTI or AP were recruited. A total of 68.2% patients (224 men, 219 women) were diagnosed with cUTI, and 31.8% (198 women, 9 men), with AP. Most (646/650 [99.4%]) infections were community acquired. The most common pathogen was Escherichia coli (65.6%), although 12.2% of patients had gram-positive pathogens. Testing for susceptibility to ampicillin and TMP/SMX found that 50.1% and 22.1% of gramnegative pathogens were fully resistant to ampicillin and TMP/SMX, respectively. However, 91.9% of isolates were susceptible to levofloxacin and ciprofloxacin, with 6.5% of isolates resistant or intermediately resistant to levofloxacin, and 9.7% of isolates resistant or intermediately resistant to ciprofloxacin at study entry (P < 0.001 [Stuart-Maxwell test]). All isolates resistant to levofloxacin were also resistant to ciprofloxacin, whereas 6 isolates that were fully susceptible to levofloxacin were fully resistant to ciprofloxacin. CONCLUSION: In this study, the level of fluoroquinolone susceptibility of urinary pathogens was high (90.6% in cUTI; 98.1% in AP).

Pharmacokinetics of pradefovir and PMEA in healthy volunteers after oral dosing of pradefovir.

The pharmacokinetics of pradefovir and adefovir, 9-(2-phosphonylmethoxyethyl) adenine (PMEA), was evaluated in healthy male volunteers after oral dosing of pradefovir (10, 30, or 60 mg). Pradefovir was absorbed rapidly. The maximum serum concentration, the area under the concentration-time curve between 0 and 96 hours after dosing (AUC(0-96)), and the area under the plasma concentration versus time curve from time 0 to infinity (AUC(0-infinity)) of pradefovir and PMEA increased with the dose of pradefovir. The ratio of PMEA to pradefovir for AUC(0-96) and AUC(0-infinity) ranged from 1.4 to 1.8. Renal clearance of pradefovir (18-31 L/h) increased with the dose of pradefovir and was greater than glomerular filtration. The fraction of total body clearance due to renal clearance was low (0.045 to 0.083), suggesting that metabolic clearance played a significant role in the clearance of pradefovir in man. In addition, an evaluation of the food effect was conducted at the 30-mg dose. The results indicate that food intake has no effect on the extent of exposure of pradefovir and PMEA but may decrease the rate of systemic availability of PMEA.

Ascending multiple-dose pharmacokinetics of viramidine, a prodrug of ribavirin, in adult subjects with compensated hepatitis C infection.

The current study was carried out to evaluate pharmacokinetic profiles of viramidine and ribavirin in patients (n = 8 per dose group) with compensated hepatitis C infection following oral dosing of viramidine (400, 600, or 800 mg bid for 4 weeks). Pharmacokinetic parameters were determined on days 1 and 29 based on plasma, red blood cell, and urine concentrations of viramidine and ribavirin. The results indicate rapid absorption and conversion of viramidine to ribavirin after oral administration of viramidine. Viramidine and ribavirin exposure in plasma and RBCs generally increased from the 400- to 600-mg dose level of viramidine. However, no further increase in exposure was noted at the 800-mg dose. Long half-lives for viramidine (66-76 hours in plasma and 200-420 hours in red blood cells) and ribavirin (340-410 hours in plasma and 360-430 hours in red blood cells) were noted. A negligible amount of viramidine (1%-4% of dose) and a small amount of ribavirin (9%-14% of dose) were excreted in the urine. The renal clearance was low for both viramidine (5-8 L/h) and ribavirin (4-7 L/h). Significant accumulation of viramidine was noted in red blood cells (accumulation factor [R] = 5-8) but not in plasma (R = 2). Extensive accumulation of ribavirin was noted in both plasma (R = 9-17) and red blood cells (R = 77-129). Steady-state levels of ribavirin and viramidine in plasma and red blood cells were achieved by day 22. At steady state, there was extensive conversion of viramidine to ribavirin in both plasma and red blood cells. Both viramidine and ribavirin were preferentially distributed into red blood cells than plasma.

Activities of carbapenem and comparator agents against contemporary US Pseudomonas aeruginosa isolates from the CAPITAL surveillance program.

Antimicrobial susceptibilities of contemporary Pseudomonas aeruginosa clinical isolates were determined from the CAPITAL 2010 surveillance program. Isolates were collected from 100 sites throughout the USA and Puerto Rico, and included isolates representing a range of patient demographics and infection types. A total of 2722 isolates were tested for susceptibility to a broad spectrum of agents, with susceptibilities ranging from 98.8% for colistin to 74% for levofloxacin. Doripenem was the most active carbapenem agent, with 88.6% of isolates susceptible, in comparison with 78.1% and 84.6% for imipenem and meropenem, respectively. Lower respiratory tract isolates and isolates from the intensive care unit setting were the least susceptible overall. Resistance rates were typically highest in lower respiratory tract isolates, with the exception of urinary tract isolates, which displayed the highest resistance for levofloxacin. Overall, multidrug-resistant isolates comprised 14.8% of the total sample population.

Comparison of the bacterial etiology of early-onset and late-onset ventilator-associated pneumonia in subjects enrolled in 2 large clinical studies.

BACKGROUND: Ventilator-associated pneumonia (VAP) is classified as early-onset or late-onset, in part, to identify subjects at risk for infection with resistant pathogens. We assessed differences in the bacterial etiology of early-onset versus late-onset VAP. METHODS: Subjects enrolled in 2004-2006 in 2 clinical studies of doripenem versus imipenem or piperacillin/tazobactam, with a diagnosis of VAP (n = 500) were included in the analysis. Subjects were classified by ventilator status: early-onset VAP (< 5 d of ventilation) or late-onset VAP (≥ 5 d of ventilation). Baseline demographics and bacterial etiology were analyzed by VAP status. RESULTS: Late-onset VAP subjects had higher Acute Physiology and Chronic Health Evaluation (APACHE II) scores (mean 16.6 versus 15.5, P = .008). There were no significant differences in Clinical Pulmonary Infection Score, sex, age, or presence of bacteremia between the groups. A total of 496 subjects had a baseline pathogen, and 50% of subjects in each group had ≥ 2 pathogens. With the exception of Staphylococcus aureus, which was common in early-onset VAP, the pathogens (including potentially multidrug-resistant (MDR) pathogens) isolated from early-onset versus late-onset VAP were not significantly different between groups. Acinetobacter baumannii or Pseudomonas aeruginosa with decreased susceptibility to any study drug was observed in early-onset and late-onset VAP subjects. CONCLUSIONS: There were no significant differences in the prevalence of potential MDR pathogens associated with early-onset or late-onset VAP, even in subjects with prior antibiotics. Empiric therapy for early-onset VAP should also include agents likely to be effective for potential MDR pathogens. Further prospective studies should evaluate microbiology trends in subjects with VAP.

Risk evaluation and mitigation strategies (REMS): educating the prescriber.

The US FDA Amendments Act of 2007 was signed into law on 27 September 2007. A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (REMS). REMS are deemed necessary when a question exists as to whether the benefits of a drug outweigh its risks. REMS constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients. This applies to existing drugs on the market, new drug applications (NDAs), abbreviated NDAs (generics) and biologics licence applications. REMS represent an 'upgrade' from previously required risk minimization action plans, based on the strengthening of FDA powers of authority and enforceability to incur monetary penalties against individuals representing the pharmaceutical industry who fail to comply. For illustrative purposes, we chose the drug romiplostim (Nplate®) to present an REMS, as all components were utilized to help assuage risks associated with the drug. Romiplostim is an FDA-approved drug used to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura that has a significant adverse safety profile based on the risk of changes in bone marrow reticulin formation and bone marrow fibroses, and other associated risks. This review of current REMS policy is intended to provide the prescriber with a better understanding of current modalities in FDA-mandated drug safety programmes, which will impact day-to-day healthcare provider practices.

Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed.

INTRODUCTION: Enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized the FDA to require manufacturers to submit Risk Evaluation and Mitigation Strategy (REMS) when it was deemed necessary to ensure that a drug's benefit outweigh its risk. REMS apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs). The objective of this review is to describe the impact of REMS requirements on the pharmaceutical industry. AREAS COVERED: Articles were identified in MEDLINE searches through October 11, 2011, using the MeSH terms and keywords pharmaceutical industry, risk management, United States Food and Drug Administration, REMS, ETASU, and Medication Guide in various combinations. EXPERT OPINION: The new powers ascribed to the FDA are notable, as they add enforceability to safety strategies that were not part of FDA's prior risk management tools, risk minimization action plans (RiskMAPs). Failure to comply with REMS can lead to financial penalties up to $10 million, and a drug could be deemed misbranded if the REMS is not followed. The new approach to risk management via FDAAA has elevated the rigor with which manufacturers must fulfill postmarketing safety commitments.

Multidrug resistance among Acinetobacter spp. in the USA and activity profile of key agents: results from CAPITAL Surveillance 2010.

Multidrug resistance among Acinetobacter spp. leaves few effective antibiotic options for treatment. To monitor antibiotic resistance in Acinetobacter spp., the US CAPITAL 2010 Surveillance data were evaluated by patient demographics, specimen source, and hospital ward. Isolates (N=514) were collected from 65 sites across the USA and Puerto Rico. Isolates were centrally tested for susceptibility to carbapenems and key antimicrobials by broth microdilution. Colistin was the most effective agent tested, with 95% susceptibility. The overall susceptibility of Acinetobacter spp. was low (39% for piperacillin/tazobactam, 41% for levofloxacin, 45% for ceftazidime, 47-51% for the carbapenems, and 58% for tobramycin). Multidrug resistance (MDR), defined as resistance to ≥3 antimicrobial agent groups, was detected in 54% of the isolates. MDR isolates were most common among elderly patients (65%), lower respiratory tract isolates (62%), and inpatient/intensive care unit isolates (54-58%). These data update trends in the distribution and prevalence of the MDR phenotype in Acinetobacter spp.

Safety and efficacy of levofloxacin 750 mg for 2 weeks or 3 weeks compared with levofloxacin 500 mg for 4 weeks in treating chronic bacterial prostatitis.

OBJECTIVE: To compare the safety and efficacy of levofloxacin 750 mg QD for 2 weeks or levofloxacin 750 mg QD for 3 weeks to levofloxacin 500 mg QD for 4 weeks in treating chronic bacterial prostatitis (CBP). RESEARCH DESIGN AND METHODS: This was a randomized, multicenter, double-blind, noninferiority study. The primary efficacy end point was investigator assessment of clinical success in the modified intent-to-treat (mITT) population at post-therapy. National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) scores were utilized to evaluate subject-reported responses post-therapy. RESULTS: A total of 241 subjects were enrolled. At post-therapy (test of cure [TOC]), clinical success rates for levofloxacin-treated subjects (750 mg QD for 3 weeks [64.9%, 48/74]) were noninferior to 500 mg QD for 4 weeks (69.3%, 52/75: 95% CI, -19.5%, 10.6%). Success rates with levofloxacin 750 mg QD for 2 weeks (63.0%, 46/73) were not noninferior to therapy with levofloxacin 500 mg QD for 4 weeks (95% CI, -21.5%, 8.9%) at TOC. At 3 and 6 months post-therapy, clinical success rates were clinically higher for the 500-mg, 4-week treatment group, and statistical analysis demonstrated both groups were not noninferior to standard therapy with levofloxacin 500 mg (95% CI, -32.5%, -0.6% for both 750-mg groups at 6 months). NIH-CPSI scores showed similar trends. Overall, adverse event (AE) rates were similar for the three treatment groups; however, discontinuation of therapy due to AEs was higher with the 750-mg dose (p = 0.02, and p = 0.13 for 750 mg, 2 weeks and 750 mg, 3 weeks versus 500 mg for 4 weeks, respectively). The main limitation of this study was that no bacterial cultures were required. CONCLUSIONS: Higher doses for shorter durations were determined to be no worse than standard therapy with levofloxacin 500 mg for a longer duration at the TOC visit. However, at the 6-month follow-up visit, the levofloxacin 750-mg dose administered for either 2 weeks or 3 weeks was inferior to the standard therapy, suggesting that a longer duration of treatment may help extend the relapse-free interval in patients with CBP. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, nct00402688.

Levofloxacin for the treatment of pneumonia caused by Streptococcus pneumoniae including multidrug-resistant strains: pooled analysis.

OBJECTIVE: To determine the clinical and microbiologic efficacy of levofloxacin for the treatment of subjects with pneumonia caused by multidrug-resistant (MDR) Streptococcus pneumoniae (MDRSP) and non-MDRSP strains. RESEARCH DESIGN AND METHODS: A pooled analysis was conducted using data from ten clinical studies in pneumonia: five comparative studies and five noncomparative studies conducted from 1992 to 2002. This analysis included data from levofloxacin-treated subjects with S. pneumoniae isolated at study entry. Susceptibility of S. pneumoniae isolated from subjects at study entry was determined against representative agents from five antimicrobial classes: tetracyclines, sulfonamides, second-generation cephalosporins, penicillins, and macrolides. Isolates were classified as MDRSP (based on resistance to two or more antimicrobial classes) or non-MDRSP (intermediate resistance or susceptible to all classes or resistant to 1 antimicrobial class). Clinical and microbiologic efficacy of levofloxacin (i.v., p.o., or i.v./p.o. for 5 to 14 days) in the microbiologically evaluable population was determined at post-therapy; a test for homogeneity of the odds ratio of the difference in clinical success for comparative versus noncomparative studies was performed. MAIN OUTCOME MEASURES AND RESULTS: The main outcome measures were clinical success rates and microbiologic eradication rates of 419 microbiologically evaluable levofloxacin-treated subjects with MDRSP or non-MDRSP. Clinical success rates were 96.3% (52/54) and 95.1% (347/365), respectively (difference -1.2; 95% confidence interval [CI]: -6.7, 4.3). Similarly, per pathogen microbiologic eradication rates for MDRSP and non-MDRSP were 96.3% (52/54) and 95.6% (350/366), respectively (difference -0.7; 95% CI: -6.1, 4.8). Study limitations include the use of data from comparative and noncomparative studies. A test for homogeneity of the odds ratios for clinical success in comparative versus noncomparative studies showed no significant difference (p = 0.27). CONCLUSIONS: These data support the use of levofloxacin for patients with community-acquired pneumonia caused by S. pneumoniae, including MDR strains.

Levofloxacin versus azithromycin on the oropharyngeal carriage and selection of antibacterial- resistant streptococci in the microflora of healthy adults.

OBJECTIVE: To determine the proportion of subjects with oropharyngeal streptococci resistant to either levofloxacin or azithromycin prior to and during antibacterial exposure, and to follow temporal changes in the proportion of resistant and susceptible isolates through 6 weeks post-exposure. This randomized, open-label, single-center study is registered with ClinicalTrials.gov (identifier: NCT00821782). RESEARCH DESIGN AND METHODS: A total of 143 healthy volunteers (levofloxacin, n = 71; azithromycin, n = 72) without antibacterial exposure in the previous 90 days received either levofloxacin 750 mg once daily for 5 days or azithromycin 500 mg once daily on day 1 and 250 mg once daily on days 2 through 5. Oropharyngeal cultures were obtained pre-exposure, at day 5, and at 2, 4, and 6 weeks post-dosing. Bacterial strains were identified and the minimum inhibitory concentrations for levofloxacin and azithromycin were determined. RESULTS: At study entry 117 streptococci were isolated from 72 subjects randomized to azithromycin and 53 (45.3%) were azithromycin-resistant. None of the 121 streptococci isolated from 71 subjects randomized to.levofloxacin were colonized by a levofloxacin-resistant microorganism prior to dosing. At the end of dosing, the number of subjects with resistant streptococci (S. mitis, S. salivarius, S. sanguis, or alpha streptococcus species [spp.]) increased in azithromycin-exposed subjects and resistant isolates remained through 6 weeks post-dosing. In contrast, a small number of levofloxacin-resistant streptococci were observed at the end of dosing but decreased by week 2 post-dosing and continued to decrease through the 6-week evaluation period (p < 0.001 azithromycin vs. levofloxacin for S. mitis, S. salivarius, S. sanguis and alpha streptococcus spp. at week 6). Limitations of this study included the fact that, since previous antibiotic use was self-reported, genetic typing was not done. The results of this study may not be completely generalizable, because subjects in this study received study drug under directly-observed conditions, thus ensuring compliance. CONCLUSIONS: Both antibacterial agents were well tolerated. Levofloxacin 750 mg administered for 5 days was associated with less microbial resistance than that observed with azithromycin in healthy subjects.

Meta-analysis of doripenem vs comparators in patients with pseudomonas infections enrolled in four phase III efficacy and safety clinical trials.

OBJECTIVE: Pseudomonas aeruginosa is a difficult-to-treat bacterial pathogen often isolated from patients with serious nosocomial infections. The goal of this analysis is to present the clinical and microbiologic effectiveness of doripenem in the treatment of infections due to P. aeruginosa. RESEARCH DESIGN AND METHODS: A meta-analysis was conducted on the subset of subjects enrolled in four randomized phase III clinical trials of doripenem in subjects with complicated intra-abdominal infections (cIAI) and nosocomial pneumonia/ventilator-associated pneumonia (NP/VAP) due to P. aeruginosa. Clinical and microbiologic success was determined by infection and across the two infections. RESULTS: Clinical success rates for modified intent-to-treat (mITT) subjects with P. aeruginosa in the cIAI and NP/VAP groups were 78.7% (37/47) and 59.6% (31/52), respectively, following treatment with doripenem versus 74.3% (26/35) and 32.8% (19/58), respectively, for subjects in the comparator groups (p < 0.05 for difference in success rates across infection types). Microbiologic eradication rates also favored doripenem, although the differences did not achieve statistical significance. The weighted difference (doripenem minus comparator) for the mITT population in clinical success rates between doripenem and the comparator agents was 16.0% (95% CI: 3.1%, 29.0%) and for microbiologic eradication rates was 9.1% (95% CI: -4.2%, 22.3%). The proportion of subjects reporting one or more treatment-emergent adverse events or serious adverse events was similar for doripenem and the comparator agents. Fourteen doripenem and 14 comparator subjects died during the study. Limitations of this retrospective meta-analysis also include the qualitative heterogeneity of the data, and a selected, narrow population of moderately ill clinical trial subjects included in the analysis. Due to limitations, these data may not be generalizable to all populations and should be considered hypothesis generating. CONCLUSION: The weighted difference in clinical success rates for subjects with cIAI and NP/VAP infections caused by P. aeruginosa was in favor of doripenem, with the relative benefit of doripenem compared with the comparator agents similar across the two infections.

A double-blind, randomized comparison of levofloxacin 750 mg once-daily for five days with ciprofloxacin 400/500 mg twice-daily for 10 days for the treatment of complicated urinary tract infections and acute pyelonephritis.

OBJECTIVES: A clinical study was conducted to compare the efficacy and safety of levofloxacin 750 mg once daily for 5 days to ciprofloxacin twice daily for 10 days for the treatment of complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). METHODS: A multicenter, double-blind, randomized, noninferiority study enrolled subjects with AP or cUTI. Subjects received either levofloxacin 750 mg intravenously or orally once daily for 5 days or ciprofloxacin 400 mg intravenously and/or ciprofloxacin 500 mg orally twice daily for 10 days and were evaluated at end of therapy, posttherapy, and poststudy for microbiologic eradication and clinical outcome. RESULTS: A total of 1109 subjects were enrolled; 619 with confirmed diagnosis of AP or cUTI and a study entry uropathogen with a colony count 10(5) CFU/mL or greater and were included in the modified intent-to-treat population. Five hundred six subjects met all criteria for inclusion and were included in the microbiologically evaluable population. At end of therapy, eradication rates in the modified intent-to-treat population were 79.8% for levofloxacin and 77.5% for ciprofloxacin-treated subjects (95% CI, -8.8% to 4.1%). In the microbiologically evaluable population, eradication rates were 88.3% for levofloxacin and 86.7% for ciprofloxacin-treated subjects (95% CI, -7.4% to 4.2%). Outcomes were comparable for the 2 treatments at posttherapy and poststudy. CONCLUSIONS: This study demonstrates that both drug regimens are safe and effective and that a 5-day course of therapy with levofloxacin, administered at a dose of 750 mg once daily, is noninferior to a 10-day course of therapy with ciprofloxacin for the treatment of AP and cUTI.

The use of knee-length versus thigh-length compression stockings and sequential compression devices.

BACKGROUND: Nurses on an Acute Care Evidence Based Practice Committee, creating a policy to increase patient compliance with thromboembolic deterrent stockings (TEDS) and sequential compression devices (SCDs) for deep vein thrombosis prophylaxis, found limited literature on patient preference and response to this treatment. STUDY AIM: The study purpose was to determine whether knee-length or thigh-length TEDS and/or SCDs were more comfortable, correctly applied, and worn by patients, and to assess patient reasons for noncompliance. METHOD: A patient survey and observational data tool was designed. Six surveyors collected data (interrater reliability = 93%) from 137 randomly selected patients with orders for TEDS and/or SCDs admitted to acute care medical or surgical nursing units. RESULTS: Most patients wore thigh-length SCDs and TEDS. However, only 29.2% (n = 40) had SCDs on them at the time of survey, and 62.8% (n = 86) were compliant with TEDS. The most common reasons given for noncompliance with SCDs were that the devices were not reapplied after bathing or ambulating, or were removed because they were hot or itchy. Complaints of discomfort were highest among patients wearing thigh-length SCDs and TEDS. Problems with fit were 50% higher in those who wore thigh-length TEDS, and involved stockings that created restricting bands. Most patients understood the purpose of treatment, and older patients were more compliant than younger patients. IMPLICATIONS FOR PRACTICE: Knee-length TEDS and SCDs are more comfortable for patients, encourage higher levels of compliance with treatment, do not pose a risk for venous stasis to patients by creating restricting bands, and are less expensive. Patients need ongoing education to resume wearing TEDS and SCDs after activities of daily living, and knee-length stockings and devices would be easier to reapply. The policy in our institution was changed for the use of knee-length compression stockings and SCDs.

A trial of levofloxacin 750 mg once daily for 5 days versus ciprofloxacin 400 mg and/or 500 mg twice daily for 10 days in the treatment of acute pyelonephritis.

OBJECTIVE: A double-blind, noninferiority trial was conducted to establish the safety and efficacy of a once-daily, 5-day course of levofloxacin 750 mg compared to a twice-daily, 10-day course of ciprofloxacin in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). This report focuses on subjects with AP. RESEARCH DESIGN AND METHODS: Adult male and female subjects with clinical signs and symptoms of AP and laboratory confirmation of their diagnosis were randomized to receive one dose of levofloxacin 750 mg once daily intravenously (i.v.) or orally and one dose of placebo for 5 days, followed by placebo; or ciprofloxacin 400 mg i.v. and/or 500 mg orally twice daily for 10 days. MAIN OUTCOME MEASURES: The primary, prospectively defined end point was microbiologic eradication at post-therapy (study days 15-22). Secondary outcomes included clinical response and safety and tolerability. RESULTS: In the modified intent-to-treat (mITT) population (levofloxacin 94, ciprofloxacin 98), 83% of levofloxacin-treated and 79.6% of ciprofloxacin-treated subjects achieved microbiological eradication (difference -3.4, 95% CI -14.4%, 7.6%). In the microbiologically evaluable (ME) population (levofloxacin 80, ciprofloxacin 76), 92.5% of levofloxacin-treated vs. 93.4% of ciprofloxacin-treated subjects (difference -0.9, 95% CI -7.1%, 8.9%) achieved microbiologic eradication. Clinical success was achieved in 86.2% vs. 80.6% (mITT) and in 92.5% vs. 89.5% (ME) of levofloxacin-treated and ciprofloxacin-treated subjects, respectively. Escherichia coli was the most commonly isolated uropathogen. Few (2.1%) of the pathogens were fluoroquinolone-resistant. Adverse events (AEs) were similar to those seen previously with both agents. Potential limitations are that this analysis is based on a subset of subjects from a larger study and, because of different durations of therapy, the results may be biased against levofloxacin. CONCLUSIONS: High-dose, short-course therapy with levofloxacin in subjects with AP is at least as effective as standard 10-day therapy with ciprofloxacin.