FDA announces recall of antimicrobial susceptibility testing cards
The US Food and Drug Administration (FDA) reported yesterday that French diagnostics firm bioMerieux has recalled two of its antimicrobial susceptibility testing (AST) cards because of false results for some strains of methicillin-resistant Staphylococcus aureus (MRSA).
According to a statement on the FDA website, bioMerieux initiated the recall for the VITEK 2 Gram Positive Cefoxitin Screen and VITEK 2 Gram Positive AST for Oxacillin cards on Jan 26 because of false-negative or false-susceptible results, respectively, for some strains of MRSA. Inappropriate treatment of MRSA because of false susceptibility or false-negative results could cause severe health consequences.
The FDA says hospitals and clinics that use the VITEK 2 system and Gram Positive AST cards to screen for MRSA, and patients who are being screened, are likely to be affected by the recall. BioMerieux has issued a MRSA Safety Alert letter directing labs to implement a custom VITEK 2 System Software BIOART Rule to aid in mitigating potential non-detection of MRSA and to send isolates of suspect strains to the firm for additional testing.
The FDA has identified this as a Class I recall, the most serious type of medical device recall.
Aug 23 FDA statement
Analysis finds ASPs in dialysis clinics could reduce infections, costs
An analysis yesterday in the Clinical Journal of the American Society of Nephrology indicates that implementation of antimicrobial stewardship programs (ASPs) in outpatient dialysis facilities might help reduce infections caused by multidrug-resistant organisms (MDROs) and Clostridium difficile,infection-related deaths, and costs.
For the analysis, researchers from Brown University, Rhode Island Hospital, and global health economics and outcomes research company Cornerstone Research Group developed a clinical decision model to examine the potential impact of implementing a nationwide ASP in outpatient dialysis facilities, where approximately 30% of antimicrobial doses are considered unnecessary. Assuming a 20% reduction in unnecessary doses, the model predicted that nationwide ASP implementation would result in 2,182 fewer infections caused by MDROs and C difficile (a 4.8% reduction), 629 fewer infection-related deaths (a 4.6% reduction), and cost-savings of $106,893,517 per year (a 5.0% reduction).
"This paper emphasizes the importance of improving antimicrobial prescribing in dialysis facilities in improving the health of patients on maintenance hemodialysis," lead author Erik D'Agata, MD, MPH, said in a press release from the American Society of Nephrology, publisher of the journal.
Aug 23 Clin J Am Soc Nephrol abstract
Aug 23 American Society of Nephrology press release
Brazilian study suggests outpatient settings as MDRO transmission source
A single-center study by a team of Brazilian researchers suggests that transmission of community-onset multidrug-resistant organisms (CO-MDROs) in outpatient settings may be underreported and understudied.
In a letter to the editor yesterday in the American Journal of Infection Control, the researchers reported that their study of a 350-bed hospital in the city of Barau identified 166 patients harboring CO-MDROs from 2014 through 2016. The organisms included MRSA (72 patients), vancomycin-resistant enterococci (3), carbapenem-resistant Acinetobacter baumannii (49), carbapenem-resistant Pseudomonas aeruginosa (25), and carbapenem-resistant Enterobacteriaceae (17).
Multivariable analysis found that pulmonary disease (odds ratio [OR], 2.30) and previous hospital admission (OR, 1.51) were risk factors for overall CO-MDROs. But previous hospital admission was only reported for 45.7% of case patients, and only 27.7% had been admitted to a hospital in the previous year. In addition, while previous admission was found to be a risk factor for gram-positive pathogens, it was not identified as a risk factor for gram-negative pathogens. Risk factors for gram-negative pathogens included age (OR, 1.02), pulmonary disease (OR, 2.53) and liver disease (OR, 4.05)
The authors say the detection of CO-MDROs in patients without recent exposure to hospitals or invasive procedures argues for long-term harboring of those organisms or for transmission in other settings. "The association of MDROs with underlying conditions that require outpatient care suggests the possibility of transmission in ambulatory settings," they conclude. "This finding opens a new venue for both research and infection control practice."
Aug 23 Am J Infect Control study
UK officials issue draft guidance for acute cough treatment
Originally published by CIDRAP News Aug 23
Draft guidance issued today by the UK National Institute for Health and Care Excellence (NICE) recommends against offering antibiotics for acute cough associated with upper respiratory infection.
In lieu of antibiotics, the guidelines recommended that clinicians advise patients who are not systematically unwell or at risk of higher complications to manage their symptoms with self-care, including honey, the herbal remedy pelargonium, and cough medicines containing the expectorant guaifenesin or the antitussive dextromethorphan (for patients over 12). They also advise clinicians to explain why antibiotics aren't necessary and encourage patients to return if symptoms worsen rapidly or do not improve after 3 to 4 weeks.
For people who are identified at a face-to-face clinical examination as systematically very unwell, the guidelines recommend an immediate prescription of doxycycline (in patients 18 and older) or amoxicillin (in patients under 18). For those identified as having a higher risk of complications, including patients with a pre-existing condition, young children born prematurely, and patients over the age of 65 with prior hospitalization and comorbidities, the guidelines suggest an immediate antibiotic should be considered.
A public comment period on the draft guidance ends on Sep 20. Publication of the new guidelines is expected in February 2019.
Aug 23 NICE draft guideline for acute cough
Multiplex assay reduces antibiotic treatment in kids with CNS infections
Originally published by CIDRAP News Aug 23
A single-center study conducted in Australia found that a cerebrospinal fluid multiplex assay performed on children with a confirmed central nervous system (CNS) infection reduced time to organism identification, antibiotic treatment, and duration of hospitalization, researchers report in the Pediatric Infectious Disease Journal.
The researchers at Australia's Royal Darwin Hospital looked at two cohorts of patients: A 15-month prospective cohort from February 2016 to May 2017 and a 15-month retrospective cohort from November 2014 to February 2016, when the multiplex assay, which can identify up to 14 potential pathogens in cerebrospinal fluid, was introduced. The researchers then compared the time to organism identification and antibiotic management before and after multiplex assay introduction.
Sixty-five cases of pediatric CNS infection were diagnosed over the 30-month period, with 36 diagnosed before the introduction of the assay and 29 diagnosed after. Young infants were the most commonly affected, with 80% of cases occurring in children 3 months or younger. The assay was performed on 26 of the 29 cerebrospinal isolates from children diagnosed as having a CNS infection in the prospective cohort, with enterovirus identified as the most common causative organism (14 children), followed by human parechovirus (4 children). The assay performed with 93.8% sensitivity and 90% specificity when compared with microbiologic culture or reference laboratory results.
After the assay was introduced, the median time to organism identification was reduced from 6 days to 2 days (P < 0.001), median duration of antibiotic therapy fell from 3 days to 2 days (P < 0.001), and median duration of hospitalization fell from 5 days to 3 days (P = 0.016).
The authors of the study say the reduction in the duration of broad-spectrum antibiotic use could reduce short- and long-term adverse drug effects, including disruption of the neonatal gut microbiome. They suggest the multiplex assay could be of most value to hospitals that don't have an onsite molecular laboratory.
September Pediatr Infect Dis J abstract
Study supports oral antibiotic monotherapy for most kids with UTIs
Originally published by CIDRAP News Aug 21
A study today in Pediatrics suggests that a dose of parenteral antibiotics prior to discharge from the emergency department (ED) is likely not necessary for most young children with urinary tract infections (UTIs).
In the study, researchers conducted a retrospective analysis of administrative data from 26 hospitals from 2010 through 2016 to better understand the value of a single dose of parenteral antibiotics in children with UTIs who are well enough to be discharged from the ED. While oral antibiotics are as effective as parenteral antibiotics in the treatment of UTIs in young children, and the American Academy of Pediatrics UTI guidelines recommend oral antibiotics alone for children with UTIs who are able to tolerate oral intake and are not ill-appearing, the administration of parenteral antibiotics before ED discharge remains a common practice.
The primary outcome of the study was an ED revisit within 3 days requiring admission. All ED revisits served as a secondary outcome.
Overall, 29,919 children with a median age of 8.6 months were included in the analysis; 36% (10,849) of those children received parenteral antibiotics before ED discharge, 4.0% (1,199) had a 3-day ED revisit, and 1.1% (336) had a 3-day revisit with admission. After adjusting for demographic factors, clinical severity, and hospital-level factors, the researchers found that ED revisit rates with admission were similar among patients who received parenteral antibiotics and those who did not (1.3% vs. 1.0%; risk difference, 0.3%). Overall ED revisit rates were higher among patients who received parenteral antibiotics (4.8% vs. 3.3%; risk difference, 1.5%).
The authors of the study say the findings support the goal of using oral antibiotics as monotherapy for most children who are discharged with UTIs.
Aug 21 Pediatrics study
Researchers develop method for real-time surveillance of drug-resistant TB
Originally published by CIDRAP News Aug 21
A study today in PLoS Medicine by US and South African researchers describes a method to monitor drug-resistant tuberculosis (TB) by identifying high-burden communities using routinely collected laboratory data.
South Africa has one of the highest TB incidence rates globally (781 per 100,000 inhabitants), yet little is known about the spatial heterogeneity of TB or drug-resistant TB within the country. This kind of spatial information is required to understand where drug-resistant TB exists, to determine why it persists in those communities, and to create appropriate control and elimination strategies.
To derive spatial estimates of drug-resistant TB in the country, the researchers retrospectively identified cases of TB and rifampicin-resistant TB (RR-TB) from all biological samples submitted for testing to the Western Cape National Health Laboratory Services (NHLS) from 2008 through June 2013. Because the NHLS database lacks unique patient identifiers, the researchers created a person-matching algorithm to match specimen records to individual patients. Cases were then aggregated by clinic location to estimate the percentage of RR-TB cases per clinic.
Of the 799,779 individuals who were mappable to clinic locations, 27.8% (222,735) had microbiologically confirmed TB, and, of these, 4.6% (10,255) had RR-TB. Mapping of cases at the clinic level showed that while the median percentage of RR-TB diagnosed at clinics was 4.3%, the percentage of diagnosed RR-TB cases ranged from 0% to 25% across Western Cape province, with significant yearly fluctuations in RR-TB percentages at several locations.
"Maps such as the ones we have created can be the platform for this next generation of disease surveillance," the authors of the study conclude. "Improved knowledge of subnational geographic variability of RR-tuberculosis is essential for the improved design and implementation of national and local responses to reduce drug-resistant tuberculosis transmission and for timely context-specific resource allocation."
Aug 21 PLoS Med study