The anti-cytomegalovirus (CMV) activity and safety of oral maribavir in CMVseropositive allogeneic stem-cell transplant recipients were evaluated in a randomized, double-blind, placebocontrolled, dose-ranging study. After engraftment, 111 patients were randomized to receive CMV prophylaxis with maribavir (100 mg twice daily, 400 mg once daily, or 400 mg twice daily) or placebo. Within the first 100 days after transplantation, the incidence of CMV infection based on CMV pp65 antigenemia was lower in each of the respective maribavir groups (15%, P ؍ .046; 19%, P ؍ .116; 15%, P ؍ .053) compared with placebo (39%). Similarly, the incidence of CMV infection based on plasma CMV DNA was lower in each of the respective maribavir groups (7%, P ؍ .001; 11%, P ؍ .007; 19%, P ؍ .038) compared with placebo (46%). Anti-CMV therapy was also used less often in patients receiving each respective dose of maribavir (15%, P ؍ .001; 30%, P ؍ .051; 15%, P ؍ .002) compared with placebo (57%). There were 3 cases of CMV disease in placebo patients but none in the maribavir patients. Adverse events, mostly taste disturbance, nausea, and vomiting, were more frequent with maribavir. Maribavir had no adverse effect on neutrophil or platelet counts. These results show that maribavir can reduce the incidence of CMV infection and, unlike ganciclovir, does not cause myelosuppression. This trial is registered at www. ClinicalTrials.gov as #NCT00223925.
A multicenter survey of 11 cancer centers was performed to determine the rate of hospital-onset Clostridium difficile infection (HO-CDI) and surveillance practices. Pooled rates of HO-CDI in patients with cancer were twice the rates reported for all US patients (15.8 vs 7.4 per 10,000 patient-days). Rates were elevated regardless of diagnostic test used.In 2011, an estimated 1.6 million people underwent treatment for cancer. 1 Clostridium difficile is the most common bacterial cause of healthcare-associated diarrhea in persons receiving chemotherapy for cancer. Several risk factors in this population raise the risk of C. difficile infection (CDI). 2,3 In the last decade, with the emergence of BI/NAP1 strain the incidence and severity of CDI increased across North America and Europe, and the need for widespread surveillance became more important than ever. With the advent of public reporting for CDI, comparison of rates across centers will occur and may not take into account differences in patient populations. Therefore, we sought to determine the rate of hospital-onset (HO)-CDI and surveillance practices in a population of HSCT recipients and patients with cancer. Establishment of a benchmark for this large but unique patient group will assist both infection control practitioners and concerned consumers as they compare rates across states and hospitals.
METHODS
RESULTSA total of 11 centers participated in the survey. Hospital characteristics are shown in Table 2. Among the centers, the number of oncology beds ranged from 22 to 600 (median, 100 beds); HSCT beds, 6-80 (median, 26 beds). PCR was the most common detection method (6), followed by EIA (4) and CTA (1). Six centers are located in states where C. difficile is a reportable healthcare-associated infection (HAI).
Rates of HO-CDIA case of HO-CDI was defined as a positive result of a laboratory assay for C. difficile toxin A and/or B following in-patient admission. The cutoff used was >48 hours at 5 centers and >72 hours at 6 centers.Centers using PCR as detection method had a higher median HO-CDI rate (1.72 per 1,000 patient-days) compared to EIA (0.9 per 1,000 patient-days; Figure 1). Among the centers that use PCR, the median HO-CDI rate was highest when the 48-hour cutoff from admission was used to define an HO-CDI case: 2.2 per 1,000 patient-days (more than 48 hours) and 1.57 per 1,000 patient-days (more than 72 hours).
Relapse versus second new infectionMost centers followed the ad hoc C. difficile surveillance working group's criteria for recurrent infection. 6 In total, 7 of 9 centers that track recurrent cases consider an episode occurring more than 8 weeks after the index episode as a second new infection. One center uses 12 weeks as the interval and another center only considers a recurrent episode occurring at least 6 months after the index episode as second new infection.
Duration of isolationIsolation practice for C. difficile varied widely across all centers. Two of 11 centers isolated patients with CDI for the entire duration of hos...
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