<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_407"
                     title="ICU Catheter Infections Can Be Virtually Eliminated (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/CriticalCare/InfectionControl/tb/18308?impressionId=1265783421077"
                     
      Catheter-related infections aren&apos;t inevitable in the ICU, according to a quality initiative that maintained rates at nearly zero for three years in Michigan hospitals.&lt;br&gt;
&lt;br&gt;The maintenance phase, after initial implementation of low-tech measures such as handwashing and removal of unneeded catheters, saw no rebound in catheter-related infections, Peter J. Pronovost, MD, PhD, of Johns Hopkins, and colleagues reported online in &lt;em&gt;BMJ&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;The first 18 months of their &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/4771&quot; mce_href=&quot;http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/4771&quot; target=&quot;_blank&quot;&gt;Keystone ICU initiative&lt;/a&gt; dropped catheter-related interventions from a mean of 7.7 and median of 2.2 per 1,000 catheter days down to 1.3 and 0, respectively.&lt;br&gt;
&lt;br&gt;At the 36 month mark, infection rates remained almost nil, at a mean of 1.1 and median of 0 per 1,000 catheter days.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&quot;For the most part, hospitals view these infections as inevitable, as the cost of doing business, that patients are too sick, that these can&apos;t be prevented,&quot; Pronovost told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;That&apos;s just not true.&quot;&lt;/p&gt;
&lt;p&gt;Catheter-related infections are the number one cause of preventable death in hospitals and ICUs, ahead of even ventilator-related pneumonia, he noted.&lt;/p&gt;
&lt;p&gt;The changes seen at the 90 Michigan ICUs that stayed with the catheter-related infection initiative were impressive, representing one of the largest and longest improvements the field has seen.&lt;/p&gt;
&lt;p&gt;Often, quality initiatives fail on durability after the study funding and resources disappear, and hospitals are left on their own, Pronovost noted.&lt;/p&gt;
&lt;p&gt;&quot;If you push you might get some effect, but then you stop pushing  --  in other words the external control goes away  --  and the performance goes right back down,&quot; he said in an interview. &quot;It can&apos;t just be the stick that drives it.&quot;&lt;/p&gt;
&lt;p&gt;The intervention started with 103 ICUs that implemented strategies to reduce rates of catheter-related bloodstream infections rates over 18 months, with measurement and feedback of infection rates.&lt;/p&gt;
&lt;p&gt;The strategies aimed at improving execution of five evidence-based recommendations, as follows: &lt;ul&gt; &lt;li&gt;Hand washing before insertion of the catheter&lt;/li&gt; &lt;li&gt;Using gowns and full barrier precautions at catheter insertion&lt;/li&gt; &lt;li&gt;Cleaning the skin with chlorhexidine before catheter insertion&lt;/li&gt; &lt;li&gt;Avoiding the femoral site when possible&lt;/li&gt; &lt;li&gt;Removing unnecessary catheters&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Then, over the subsequent 18-month maintenance period, ICU teams were instructed to integrate this intervention into staff orientation, to collect monthly data from hospital infection control staff, and to report infection rates to physicians and others.&lt;/p&gt;
&lt;p&gt;Along with the sustained reduction in overall catheter-related infections, the researchers found a prolonged reduction in bloodstream infections that was significant during all study periods, compared to baseline.&lt;/p&gt;
&lt;p&gt;Rates decreased from a mean of 7.7 and median 2.7 of per 1,000 catheter days at baseline to 1.3 and 0, respectively, at 16 to 18 months after implementation. They remained at 1.1 and 0 at months 34 to 36 (-1% versus 18 months, 95% CI -9% to +7%).&lt;/p&gt;
&lt;p&gt;ICU teams interviewed attributed the continuously low rates to five factors: &lt;ul&gt; &lt;li&gt;Continued feedback on infection data&lt;/li&gt; &lt;li&gt;Improvements in safety culture as part of the project&lt;/li&gt; &lt;li&gt;An &quot;unremitting belief in the preventability of bloodstream infections&quot;&lt;/li&gt; &lt;li&gt;Involvement of senior leaders&lt;/li&gt; &lt;li&gt;A noncompetitive, shared goal to reduce infection rates throughout the state&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Of these, Pronovost called culture change in the ICUs the key factor to sustainability, although the researchers cautioned that which aspects contributed were not formally evaluated.&lt;/p&gt;
&lt;p&gt;They said they could not determine the impact incentive payments from Blue Cross Blue Shield of Michigan to hospitals that continued their participation  --  payments that were based on performance thresholds in subsequent years.&lt;/p&gt;
&lt;p&gt;Pronovost&apos;s team is now working to implement the quality initiative state-by-state nationwide, supported by the Agency for Healthcare Research and Technology.&lt;/p&gt;
&lt;p&gt;&quot;It seems absurd that this wouldn&apos;t be in every hospital in the country,&quot; he said in an interview. &quot;It&apos;s worked on a large scale, it&apos;s exceedingly cheap, there&apos;s no fancy technology.&quot;&lt;/p&gt;
&lt;p&gt;Success isn&apos;t only for community hospitals, Pronovost emphasized.&lt;/p&gt;
&lt;p&gt;Large, often academic, medical centers frequently express the conviction that their sicker, more complex ICU population wouldn&apos;t produce the same results, that their infections truly are inevitable, he said.&lt;/p&gt;
&lt;p&gt;&quot;To them I say, Not so,&quot; he told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;We have shown at Johns Hopkins, at the University of Michigan, at Pittsburgh, using a similar but different approach, at Tufts  --  many large academic medical centers have had dramatic reductions of these infections.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The project was supported, for the period from October 2003 to September 2005, by the Agency for Healthcare Research and Quality and the Michigan Health &amp;amp; Hospital Association.&lt;/p&gt;&lt;p&gt;Pronovost and a co-author reported receiving received lecture fees from various healthcare organizations and grant support from the Agency for Healthcare Research and Quality, the Robert Wood Johnson Foundation, the National Patient Safety Agency, and the World Health Organization to study and improve quality of care, including catheter-related bloodstream infections.&lt;/p&gt;&lt;p&gt;Co-authors reported conflicts of interest with government agencies, Cubist, Astellas, Merck, Forrest, Cadence, the Robert Wood Johnson Foundation, Lilly, Edward Life Sciences, and Sage.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_301"
                     title="Tight Glucose Control Fails in Septic Shock (CME/CE)"
                     score="0.004"
                     href="http://www.medpagetoday.com/CriticalCare/Sepsis/tb/18160?impressionId=1265783421077"
                     
      Septic shock patients treated with a corticosteroid get no survival advantage from tight glucose control or addition of a second corticosteroid to provide more mineralocorticoid activity, according to results of a randomized trial.&lt;br&gt;
&lt;br&gt;Aiming for normoglycemia at 80 to 110 mg/dL rather than the standard 150 mg/dL had no impact on inhospital mortality rates (45.9% versus 42.9%, &lt;em&gt;P&lt;/em&gt;=0.50), Djillali Annane, MD, of H&amp;#244;pital Raymond Poincar&amp;#233; in Garches, France, and colleagues found.&lt;br&gt;
&lt;br&gt;Inhospital mortality was likewise similar whether patients got hydrocortisone (Solu-Cortef) alone or with the addition of fludrocortisone ([Florinef] 42.9% versus 45.8%, &lt;em&gt;P&lt;/em&gt;=0.50), they reported in the Jan. 27 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;This aggressive treatment strategy should not be routine, the researchers recommended.&lt;/p&gt;
&lt;p&gt;These findings largely match the general lack of benefit seen with tight glycemic control in recent studies with ICU patients overall.&lt;/p&gt;
&lt;p&gt;The prematurely terminated &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/SCCM/5096&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/SCCM/5096&quot; target=&quot;_blank&quot;&gt;European Glucontrol Trial&lt;/a&gt; found no mortality benefit but a seven-fold higher risk of hypoglycemia with an 80 to 110 mg/dL target in the ICU.&lt;/p&gt;
&lt;p&gt;In the &lt;a href=&quot;http://www.medpagetoday.com/CriticalCare/Intensivists/13397&quot; mce_href=&quot;http://www.medpagetoday.com/CriticalCare/Intensivists/13397&quot; target=&quot;_blank&quot;&gt;NICE-SUGAR&lt;/a&gt; study, 90-day mortality was actually higher in the tight glucose control group (27.9% versus 24.9%, &lt;em&gt;P&lt;/em&gt;=0.02), although there was a trend for benefit in patients who got corticosteroids (&lt;em&gt;P&lt;/em&gt;=0.06).&lt;/p&gt;
&lt;p&gt;Glucose targets are being re-evaluated across medicine as the &quot;lower is better&quot; paradigm has had a safety asterisk added everywhere from diabetes care to the ICU, noted Richard Bergenstal, MD, American Diabetes Association president for medicine and science.&lt;/p&gt;
&lt;p&gt;&quot;All of a sudden it&apos;s becoming more than a single number,&quot; he told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;Now be it inpatient or outpatient, we&apos;re realizing that ... you have to do it while you&apos;re minimizing hypoglycemia.&quot;&lt;/p&gt;
&lt;p&gt;A more nuanced and &lt;a href=&quot;http://www.medpagetoday.com/Cardiology/Diabetes/13818&quot; mce_href=&quot;http://www.medpagetoday.com/Cardiology/Diabetes/13818&quot; target=&quot;_blank&quot;&gt;individualized&lt;/a&gt; strategy is prudent, Bergenstal agreed.&lt;/p&gt;
&lt;p&gt;The current clinical uncertainty underscores the need for large-scale international cooperation to get adequately powered trials, according to an accompanying editorial.&lt;/p&gt;
&lt;p&gt;In it, Greet Van den Berghe, MD, PhD, of the Catholic University of Leuven, Belgium, cautioned that Annane&apos;s Corticosteroids and Intensive Insulin Therapy for Septic Shock (COIITSS) study was grossly underpowered.&lt;/p&gt;
&lt;p&gt;The initial studies that led to rapid adoption of intensive insulin therapy in ICUs around the world had suggested an absolute reduction in mortality of only 3%, whereas the COIITSS study projected a 12.5% absolute benefit.&lt;/p&gt;
&lt;p&gt;More importantly, the study achieved mean glucose levels of only between 120 and 130 mg/dL in the intervention group for whom the aim was 80 to 110 mg/dL, which resulted in considerable overlap with the standard care group for whom mean levels were about 145 mg/dL.&lt;/p&gt;
&lt;p&gt;This could account for the lack of difference in outcome, Van den Berghe said.&lt;/p&gt;
&lt;p&gt;But the intensive insulin group did have &quot;markedly&quot; lower blood glucose levels for the duration of their ICU stay and spent more time in the 80 to 110 mg/dL range compared with the standard care group (both &lt;em&gt;P&lt;/em&gt;&amp;lt;0.00001), the researchers noted.&lt;/p&gt;
&lt;p&gt;Because corticosteroids further aggravate the &quot;diabetes of injury&quot; seen with septic shock, Annane&apos;s group undertook a multicenter trial of 509 adults treated for septic shock with multiple organ dysfunction over a three year period at 11 ICUs in France.&lt;/p&gt;
&lt;p&gt;Patients were randomly assigned to tight glucose control using continuous intravenous insulin infusion to target a glucose level of 80 to 110 mg/dL or conventional insulin therapy targeted to guidelines-recommended 150 mg/dL or under. They were additionally randomized to receive hydrocortisone alone (50-mg bolus every six hours) or in combination with fludrocortisone (50-&amp;#956;g tablets once daily) for seven days.&lt;/p&gt;
&lt;p&gt;Aside from the lack of inhospital mortality advantage, tight glucose control also failed to produce a benefit for the following secondary endpoints: &lt;ul&gt; &lt;li&gt;Overall survival (hazard ratio 1.04, &lt;em&gt;P&lt;/em&gt;=0.78) &lt;/li&gt; &lt;li&gt; ICU length of stay for survivors (median 10 versus nine days, &lt;em&gt;P&lt;/em&gt;=0.68)&lt;/li&gt; &lt;li&gt;Duration of hospital stay overall (24 versus 22 days, &lt;em&gt;P&lt;/em&gt;=0.87)&lt;/li&gt; &lt;li&gt;Median vasopressor-free days (four for both, P=0.58)&lt;/li&gt; &lt;li&gt;Median mechanical ventilation-free days (10 versus 13, &lt;em&gt;P&lt;/em&gt;=0.51)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Nor was there evidence for interaction with fludrocortisone in the primary endpoint (relative risk 0.89 versus 0.91 hydrocortisone alone, &lt;em&gt;P&lt;/em&gt;=0.31) or benefit in any other endpoint.&lt;/p&gt;
&lt;p&gt;The one effect of intensive insulin appeared to be an increase in episodes of severe hypoglycemia, defined by glucose falling below 40 mg/dL (mean 0.29 versus 0.14 episodes per patient, &lt;em&gt;P&lt;/em&gt;=0.003).&lt;/p&gt;
&lt;p&gt;However, having hypoglycemia did not increase the risk of death in intervention group patients compared with controls (45.2% versus 50%).&lt;/p&gt;
&lt;p&gt;The researchers cautioned that the study did not rule out a benefit from some degree of glucose control compared with none.&lt;/p&gt;
&lt;p&gt;They also noted that healthcare providers were not blinded to administration of fludrocortisone, for which no placebo was available.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by the Assistance Publique&amp;#8211;H&amp;#244;pitaux de Paris. The researchers reported no conflicts of interest.&lt;/p&gt;&lt;p&gt;Van den Berghe, through the Catholic University of Leuven, reported receiving structural research financing from the Methusalem program, funded by the Flemish government.&lt;/p&gt;&lt;p&gt;Bergenstal reported receiving research funding and serving on advisory boards for various pharmaceutical companies related to novel diabetes drugs but without any personal financial compensation.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_255"
                     title="Biomarker Guideline Reduced Antibiotic Use (CME/CE)"
                     score="0.001"
                     href="http://www.medpagetoday.com/HospitalBasedMedicine/InfectionControl/tb/18114?impressionId=1265783421077"
                     
      &lt;p&gt;A biomarker-guided strategy for antibiotics in intensive care units reduced drug use without increasing mortality, French researchers said.&lt;/p&gt;
&lt;p&gt;In a randomized, open-label study, the biomarker procalcitonin allowed physicians to reduce the quantity of antibiotics they prescribed, according to Michel Wolff, MD, of H&amp;#244;pital Bichat-Claude-Bernard in Paris, and colleagues.&lt;/p&gt;
&lt;p&gt;In principle, the approach could slow the emergence of antibiotic resistance, Wolff and colleagues concluded online in &lt;em&gt;The Lancet&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Procalcitonin is thought to be a &quot;fairly specific marker for severe bacterial infection in patients with suspected sepsis,&quot; the researchers noted in the journal.&lt;/p&gt;
&lt;p&gt;As well, serum procalcitonin concentrations have been shown to be a useful guide to reducing antibiotic use in patients with lower-respiratory-tract infections, they said.&lt;/p&gt;
&lt;p&gt;But the value of the biomarker in reducing inappropriate antibiotic use has not been shown in all intensive care patients, they said. To fill the gap, they conducted a prospective study of 630 patients in eight French ICUs.&lt;/p&gt;
&lt;p&gt;Patients were randomly assigned to be treated according to usual antibiotic protocols or to have their therapy guided by procalcitonin levels.&lt;/p&gt;
&lt;p&gt;For patients in the procalcitonin group, doctors were encouraged to start antibiotics at inclusion if the levels were 0.5 micrograms per liter or greater. Otherwise, they were discouraged from doing so.&lt;/p&gt;
&lt;p&gt;They were also encouraged to stop antibiotics, once started, if the procalcitonin concentration fell by 80% or more from its peak, or if the concentration was below 0.5 micrograms per liter.&lt;/p&gt;
&lt;p&gt;The primary endpoints were death from any cause at 28 and 60 days and differences in antibiotic use.&lt;/p&gt;
&lt;p&gt;The researchers reported: &lt;ul&gt; &lt;li&gt;At 30 days, mortality in the procalcitonin group was 21.2%, compared with 20.4% in the control group, for an absolute difference of 0.8%. That was well below the pre-set 10% difference for non-inferiority.&lt;/li&gt; &lt;li&gt;At 60 days, the comparable figures were 30% and 26.1%, for an absolute difference of 3.8%, which also established non-inferiority.&lt;/li&gt; &lt;li&gt;Patients in the procalcitonin group had 14.3 days without antibiotics, on average, compared with 11.6 days in the control group. The absolute difference of 2.7 days was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The researchers cited a number of limitations, including the open design, which might have permitted bias, and a low number of surgical patients, which may limit how widely the findings can be applied.&lt;/p&gt;
&lt;p&gt;As well, they noted, 53% of patients in the procalcitonin group did not get therapy guided by the study protocol. Despite that, Wolff and colleagues said, the results remained statistically significant if those patients were excluded.&lt;/p&gt;
&lt;p&gt;Various studies have shown that it&apos;s possible to curtail unnecessary antibiotic use in hospitals, according to Marin Kollef, MD, of Washington University School of Medicine in St Louis.&lt;/p&gt;
&lt;p&gt;But because of the limitations of the French study, it remains unclear whether using procalcitonin is the best approach, he wrote in an accompanying editorial.&lt;/p&gt;
&lt;p&gt;&quot;Whether the ideal strategy involves the use of a serum marker such as procalcitonin or a locally applied practice protocol remains to be established,&quot; Kollef concluded.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by the Assistance Publique-H&amp;#244;pitaux de Paris, France, and Brahms, Germany. Wolff reported financial links with Merck Sharp &amp;amp; Dohme-Chibret, Janssen-Cilag, Gilead, and AstraZeneca.&lt;/p&gt;&lt;p&gt;Kollef reported no conflicts.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_216"
                     title="Novel Treatment Cuts Recurrence of &lt;em&gt;C. difficile&lt;/em&gt; (CME/CE)"
                     score="-0.004"
                     href="http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/tb/18067?impressionId=1265783421077"
                     
      &lt;p&gt;Adding two investigational monoclonal antibodies to standard antibiotics reduced the rate of recurrent &lt;em&gt;Clostridium difficile &lt;/em&gt;infection, a phase II randomized controlled trial showed.&lt;/p&gt;
&lt;p&gt;Patients who received a single infusion with the two monoclonal antibodies were significantly less likely to have a recurrence through 84 days of follow-up than those who received placebo (7% versus 25%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), according to Israel Lowy, MD, PhD, of Medarex in Princeton, N.J., and colleagues.&lt;/p&gt;
&lt;p&gt;Adverse events occurred at similar rates in the two groups, the researchers reported in the Jan. 21 &lt;em&gt;New England Journal of Medicine.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Medarex is a subsidiary of Bristol-Myers Squibb focused on developing fully human antibody-based therapies.&lt;/p&gt;
&lt;p&gt;&quot;The trial results are impressive,&quot; Lorraine Kyne, MD, MPH, of University College Dublin, wrote in an accompanying editorial.&lt;/p&gt;
&lt;p&gt;Although monoclonal antibodies probably would not be used as first-line treatment, she said, &quot;this novel nonantibiotic approach to secondary prevention is likely to offer hope to physicians and patients battling &lt;em&gt;C. difficile&lt;/em&gt; infection.&quot;&lt;/p&gt;
&lt;p&gt;Agreeing was Neil Fishman, MD, of the University of Pennsylvania, who called the findings &quot;very encouraging and very exciting&quot; in an interview.&lt;/p&gt;
&lt;p&gt;However, he noted that the safety of the treatment would have to be established in a much higher number of patients.&lt;/p&gt;
&lt;p&gt;The proper place for the antibody therapy in the management of &lt;em&gt;C. difficile&lt;/em&gt; needs to be established in future studies as well, said Fishman, who is also chair of the antimicrobial resistance work group for the Infectious Diseases Society of America.&lt;/p&gt;
&lt;p&gt;Whether it should be administered during a first episode or at first recurrence is an open question, he said, and the answer will depend both on phase III results and cost, which tends to be high for monoclonal antibody therapies.&lt;/p&gt;
&lt;p&gt;Still, he said, &quot;All disclaimers aside, I think this is a very significant, important study and an important new development in the management of &lt;em&gt;C. difficile&lt;/em&gt;.&quot;&lt;/p&gt;
&lt;p&gt;Lowy&apos;s group wrote in the journal that new therapies are needed to manage &lt;em&gt;C. difficile&lt;/em&gt;, which is increasing in prevalence and severity.&lt;/p&gt;
&lt;p&gt;Some 15% to 30% of patients will have a recurrence despite antibiotic treatment, which itself puts patients at risk for &lt;em&gt;C. difficile&lt;/em&gt; diarrhea or colitis. Broad-spectrum antibiotics knock the infection down but do not allow for the re-establishment of normal bowel flora.&lt;/p&gt;
&lt;p&gt;In addition, a hypervirulent strain  --  called BI/NAP1/027 --  has emerged in several large, deadly outbreaks in the U.S., Canada, and Europe. (See &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/PublicHealth/2254&quot; mce_href=&quot;http://www.medpagetoday.com/InfectiousDisease/PublicHealth/2254&quot; target=&quot;_blank&quot;&gt;Virulent Strain of &lt;em&gt;C. Difficile&lt;/em&gt; Called Cause of Diarrhea Outbreaks&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;The two fully human, monoclonal antibodies evaluated by Lowy&apos;s group  --  one each against &lt;em&gt;C. difficile&lt;/em&gt; toxins A (CDA1) and B (CDB1)  --  showed efficacy in a hamster model and safety in healthy people.&lt;/p&gt;
&lt;p&gt;To further establish safety and efficacy, the researchers enrolled 200 patients with &lt;em&gt;C. difficile&lt;/em&gt; infection at 30 sites in the U.S. and Canada and randomized half to receive the antibodies and half to placebo.&lt;/p&gt;
&lt;p&gt;The antibodies were given together in a single infusion, both at a dose of 10 mg/kg.&lt;/p&gt;
&lt;p&gt;All patients were also receiving either metronidazole or vancomycin.&lt;/p&gt;
&lt;p&gt;In the antibody group, all cases of recurrence within 84 days of infusion occurred in patients who had been hospitalized during their initial episode.&lt;/p&gt;
&lt;p&gt;Echoing the primary finding, the rate of recurrence was significantly lower following the antibody infusion among the subgroup of patients who had had more than one previous episode of &lt;em&gt;C. difficile&lt;/em&gt; infection (7% versus 38%, &lt;em&gt;P&lt;/em&gt;=0.006).&lt;/p&gt;
&lt;p&gt;The recurrence rate also tended to be lower in the antibody group among patients who had the epidemic BI/NAP1/027 strain (8% versus 32%), although the difference did not reach statistical significance (&lt;em&gt;P&lt;/em&gt;=0.06).&lt;/p&gt;
&lt;p&gt;During the initial episode, the antibody treatment did not shorten the length of hospitalization or the time to resolution or severity of diarrhea compared with placebo.&lt;/p&gt;
&lt;p&gt;The antibodies were not immunogenic.&lt;/p&gt;
&lt;p&gt;Safety from the monoclonal antibody infusion was not a concern. Adverse events during infusion or within the next two hours occurred in 15 patients in the antibody group and 10 in the placebo group. All were mild to moderate, with headache the most common.&lt;/p&gt;
&lt;p&gt;During follow-up, at least one serious adverse event was reported by 18 patients in the antibody group and 28 in the placebo group, a difference that was not statistically significant (&lt;em&gt;P&lt;/em&gt;=0.09).&lt;/p&gt;
&lt;p&gt;There were 15 deaths during the study  --  seven in the antibody group and eight in the placebo group. None was attributed to the study drug.&lt;/p&gt;
&lt;p&gt;Lowy stressed that larger studies are needed to confirm the findings.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by MassBiologics and Medarex, which employs two of the study authors.&lt;/p&gt;&lt;p&gt;Lowy and one of his co-authors reported being employees of Medarex and having an equity interest in the company. Lowy reported being named as a co-inventor on relevant patents with all rights or royalties assigned to Medarex and having an equity interest in Merck. His co-authors reported being named as co-inventors on relevant patents and sharing a partial interest in them, and having relationships with MassBiologics, Medarex, Robert Michael Associates, ViroPharma, GOJO Industries, Salix, Schering-Plough, Cepheid, Merck, TheraDoc, Optimer, and Genzyme.&lt;/p&gt;&lt;p&gt;Kyne reported receiving salary support from a Clinician Scientist Award from the Health Research Board, Ireland.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_507"
                     title="Some MRSA Infections Falling"
                     score="-0.005"
                     href="http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/tb/12930?impressionId=1265783421077"
                     
      ATLANTA, Feb. 17 -- Despite perceptions that antibiotic-resistant infections are on the rise in hospitals, there has been a consistent decline in one major category since 2001, CDC researchers said.
              &lt;br&gt; 
              &lt;br&gt;Central line-associated bloodstream infections caused by methicillin-resistant &lt;em&gt;Staphylococcus aureus&lt;/em&gt; (MRSA) increased from 1997 through 2001 and then fell substantially through 2007, according to Deron Burton, M.D., and colleagues.
              &lt;br&gt; 
              &lt;br&gt;Over the entire period from 1997 through 2007, the incidence of such infections fell 49.6%, a decline that was significant at &lt;em&gt;P&lt;/em&gt;&lt;0.001, Dr. Burton and colleagues said in the Feb.18 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.
              &lt;p&gt; 
              &lt;p&gt;Put another way, the rate was 0.43 infections per 1,000 central line days in 1997, rose to a peak in 2001, and then fell to 0.21 in 2007, the researchers reported.
              &lt;p&gt; 
              &lt;p&gt;The findings came from two CDC surveillance programs -- the National Nosocomial Infections Surveillance and its successor, the National Healthcare Safety Network.
              &lt;p&gt; 
              &lt;p&gt;In both systems, healthcare facilities chose the patient care areas under surveillance and performed surveillance for a calendar month for each area. They also chose the types of healthcare-associated infections to monitor.
              &lt;p&gt; 
              &lt;p&gt;For this analysis, the CDC looked at reported central line-associated bloodstream infections in seven types of intensive care units -- medical, surgical, combined medical-surgical units in facilities affiliated with a medical school, combined medical-surgical units in facilities without such an affiliation, cardiothoracic, coronary, and pediatric.
              &lt;p&gt; 
              &lt;p&gt;Overall, the researchers found, there were 33,587 central line-associated bloodstream infections in 1,684 ICUs, representing 16,225,498 patient-days of surveillance. Of those, 2,498 or 7.4% were MRSA and 1,590 or 4.7% involved methicillin-susceptible &lt;em&gt;S. aureus&lt;/em&gt;.
              &lt;p&gt; 
              &lt;p&gt;From 1997 through 2001, surgical, nonteaching-affiliated medical-surgical, cardiothoracic, and coronary units saw increases in MRSA-caused central line-associated bloodstream infections, but medical, teaching-affiliated medical-surgical, and pediatric units had no significant changes.
              &lt;p&gt; 
              &lt;p&gt;On the other hand, from 2001 through 2007, such infections fell significantly in all ICU types except in pediatric units, where they were stable. 
              &lt;p&gt; 
              &lt;p&gt;The researchers said the declines ranged from 51.5% in medical-surgical ICUs without a major teaching affiliation to 69.2% in surgical ICUs. Both declines were significant at &lt;em&gt;P&lt;/em&gt;&lt;0.001.
              &lt;p&gt; 
              &lt;p&gt;At the same time, MRSA occurrence rates fell continuously throughout the study period, so that MRSA infections rose 25.8% as a proportion of all infections caused by &lt;em&gt;S. aureus&lt;/em&gt;. 
              &lt;p&gt; 
              &lt;p&gt;Central line-associated bloodstream infections caused by other pathogens fell continuously and significantly (at &lt;em&gt;P&lt;/em&gt;&lt;0.001) during the study period, Dr. Burton and colleagues said.
              &lt;p&gt; 
              &lt;p&gt;One limitation of the study is that hospitals reporting to the two systems were not a continuous cohort and migration in and out of the groups may have affected the results, the researchers said.
              &lt;p&gt; 
              &lt;p&gt;It is also possible that being involved in the surveillance effort influences infection control at participating hospitals, they said, and the study was also unable to link specific infection control practices with the results. They also lacked specific data on changes in the mix of patients or patient care practices (such as the average duration of central line placement) in reporting ICUs, which could have influenced the observed trends.
              &lt;p&gt; 
              &lt;p&gt;ICUs have begun using a range of interventions over the past decade, including better hand hygiene and shorter periods of catheter use, to prevent nosocomial infections, according to Michael William Climo, M.D., of the Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Va.
              &lt;p&gt; 
              &lt;p&gt;The study &quot;leaves the unsettling realization that the observed reductions in infection cannot be attributed to any particular intervention,&quot; Dr. Climo said in an accompanying editorial.
              &lt;p&gt; 
              &lt;p&gt;On the other hand, ICUs participating in the two surveillance systems have &quot;clearly&quot; made progress at reducing hospital-acquired infections, he said, &quot;suggesting that real change is being made.&quot;
              &lt;p&gt; 
              &lt;p&gt;The downside is that &quot;most ICUs are far from the goal of zero infections and many have not implemented suggested prevention strategies,&quot; he said.
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;There was no specific financial support for the study. All of the authors are employees of the CDC.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
         
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