Stewardship / Resistance Scan for Oct 08, 2018

News brief

Report identifies bacterial pathogens that could be addressed by vaccines

A new report from the Wellcome Trust and Boston Consulting Group identifies antibiotic-resistant pathogens that could be addressed by increased vaccine uptake and vaccine development.

The report evaluates the potential health impact of vaccines against all strains of bacterial pathogens identified by the World Health Organization (WHO) as "priority pathogens." It also considers the feasibility of developing vaccines for these pathogens and the likelihood of implementing a successful vaccination program. Through this assessment, the report identifies pathogen clusters that would most benefit from a vaccine.

In the "increase uptake" cluster are the pathogens Haemophilus influenza, Streptococcus pneumoniae, and Salmonella typhi. While vaccines have been developed for these pathogens, the report recommends expanding coverage for these vaccines to increase their health impact. In the "bring to market" category are Escherichia coli, non-typhoidal Salmonella, and Shigella—pathogens with significant health impact and sufficiently advanced research and development (R&D) to recommend accelerated clinical development of a vaccine. In the "advance early R&D" cluster are pathogens with significant health impact that require more early-stage investment in R&D. These include Mycobacterium tuberculosis, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Staphylococcus aureus, and urinary E coli.

The report concludes that other pathogens on the WHO priority list—Acinetobacter baumannii, Enterobacteriaceae, Campylobacter, Klebsiella pneumoniae, Enterococcus faecium, Helicobacter pylori, and Salmonella paratyphi—are less well-suited to vaccine development because of significant outstanding epidemiological questions and low incidence and associated morbidity and mortality. It recommends exploring alternative strategies for addressing these pathogens.

"By employing a carefully considered prioritisation framework to evaluate these pathogens, this report enables comprehensive comparisons across pathogens," the report states. "This assessment and prioritisation provides a guide for research priorities, policy focus and investment decisions, while recognising that individuals and institutions have varied areas of focus and seek to interact at different parts of the value chain."
Oct 5 Vaccines for AMR report

New CDC document highlights ASP strategies for low-resource settings

The US Centers for Disease Control and Prevention (CDC) has released the latest in a series of guidelines for developing and implementing antibiotic stewardship programs (ASPs).

The Core Elements of Human Antibiotic Stewardship Programs in Resource-Limited Settings guide contains ASP strategies that can be implemented in low- and middle-income countries with weak health systems, based on the resources available. "Such strategies must be feasible, sustainable, and tailored to the resources that are currently available in such countries while capacity is built in areas of need to ensure access and reduce the inappropriate use of antibiotic agents," the report states.

The document includes both national and facility-level activities. National-level activities are grouped into basic, intermediate, and advanced categories, with basic activities requiring only limited resources and intermediate and advanced categories requiring additional resources and staff. Basic activities include setting up a national ASP committee and developing a national antibiotic stewardship plan, while intermediate and advanced activities include developing and ensuring access to recommended formularies, measuring antibiotic use, and setting national targets for improvement.

At the facility level, the guide recommends that hospitals in resource-limited settings begin by identifying a single point of contact for an ASP. That individual should preferably be an infectious disease (ID) trained physician, but could be a physician without formal ID training if necessary. In addition, the ASP focal point should have support from the hospital administration. Beyond this foundation, the guide recommends that hospitals form antibiotic stewardship committees, identify a single priority area for reducing antibiotic use, educate staff, and implement stewardship activities targeted at the priority area.

The CDC says the document, which is based on expert opinion and experiences in implementing ASPs in the United States and elsewhere, is intended to serve as a starting point for stakeholders in resource-limited settings.
Sep 24 CDC core elements guide


Nursing home study illustrates risk of resistant bacteria transmission

A multicenter study of nursing home residents has found that 11% of interactions with healthcare workers resulted in the transmission of antibiotic-resistant gram-negative bacteria (RGNB) to gloves and gowns worn by those workers when providing care.

In the study, which was published today in Infection Control and Hospital Epidemiology, investigators collected perianal swabs from 399 residents of 13 community-based nursing facilities in Maryland and Michigan to detect RGNB. Healthcare personnel (HCP) at the facilities were asked to wear gowns and gloves during usual care activities, and those items were swabbed when HCP were finished with those activities. The objective was to estimate the risk of transmission of RGNB to gloves and gowns worn by HCP when providing care and to identify the types of care and resident characteristics associated with transmission.

Overall, 19% of the residents were colonized with at least one RGNB at enrollment. Either gloves or gowns were contaminated with RGNB during 11% of 584 interactions with colonized residents. RGNB transmission to HCP varied by activity, but showering and bathing residents, changing wound dressings, and assisting with hygiene and toilet needs were associated with a high risk of transmission, while glucose monitoring and assisting with feeding or medication were associated with low risk of transmission. Residents with a pressure ulcer were three times more likely to transmit RGNB than residents without one.

The findings are noteworthy because though previous studies have found that more half (57%) of nursing home residents are colonized with multidrug-resistant organisms, there are few evidence-based guidelines describing best practices for preventing transmission of these organisms in nursing homes. The authors of the study suggest that glove and gown use in community nursing facilities should be prioritized for certain residents and care interactions that are deemed a high risk for transmission.
Oct 8 Infect Control Hosp Epidemiol abstract

News Scan for Oct 08, 2018

News brief

FDA approves expanded Gardasil 9 use in women and men aged 27 through 45

The US Food and Drug Administration (FDA) on Oct 5 announced that it approved expanded use of Gardasil 9 human papillomavirus (HPV) vaccine for women and men 27 through 45 years old. The vaccine prevents certain cancers and diseases caused by the nine HPV types contained in the vaccine.

Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research said in an FDA statement that the approval is an important opportunity to help prevent HPV-related diseases in a broader range of ages. "The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing," he added.

In June the FDA granted priority review for Merck's supplemental biologics license application for Gardasil with a target action date of Oct 6. Previously, the vaccine had been approved for use in females and males ages 9 though 26.

The FDA said its approval is based on a study of about 3,200 women 27 though 45 years of age who were followed for an average of 3.5 years. The vaccine was 88% effective in preventing persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer. The new data also included long-term follow-up. It added that the effectiveness in 27- through 45-year-old men was inferred from the data from women, efficacy data in younger males, and immunogenicity findings in a clinical trial of 150 men aged 27 through 45 who received 3 doses over a 6-month period.

In safety studies that included 13,000 males and females, the most common adverse reactions were injection-site pain, swelling, and redness and headaches.
Oct 5 FDA press release


WHO: Cases rise in Zimbabwe and Niger cholera outbreaks

Cholera activity in Zimbabwe's capital city, Harare, that began in early September is rapidly increasing, and in Niger, a cholera outbreak that began in July near the Nigerian border threatens the county's capital and some of Niger's neighbors, the World Health Organization (WHO) said Oct 5 in separate updates.

In Zimbabwe, 4,971 more cases have been reported since the WHO's last update on Sep 20. As of Oct 3, the overall total had reached 8,535 cases, 163 of them confirmed and 50 of them fatal. Most are from the densely populated capital, especially the suburbs Glen View and Burdiriro. Last week, a mass oral cholera vaccine campaign was launched in the outbreak area targeting 1.4 million people.

The WHO said the source of the outbreak is suspected to be contaminated boreholes and wells, from which nearly 70% of the urban population relies on as a water source. High demand for water in Harare, complicated by increasing rural-urban migration that is straining the infrastructure, isn't being met by the city's water supply, which is a focus of response efforts. The country is also battling a large typhoid outbreak that began in August.

Meanwhile, Niger's cholera outbreak has grown to 3,692 cases (14% have been in Nigerian residents seeking care in Niger), 68 of them fatal, from 12 health districts in 4 regions, the WHO said. The outbreak began at a known hot spot near the border with Nigeria and has spread to three geographically distinct areas. The ongoing rainy season and the rise in cases along the Nigerian border poses a high risk of spread within Niger and to other countries. Cases were recently confirmed in Niger's Dosso region, a major trading hub with links to Niger's capital city, Niamey, and to Benin. The collapse of a bridge across the Niger River at the Niger-Benin border may slow population movements in the area but could also increase travel through Burkina Faso and Nigeria.

In other African cholera developments, the pace of disease activity in Somalia over the past 10 weeks has slowed, according to an Oct 4 statement from the WHO's Regional Office for the Eastern Mediterranean (WHO EMRO). The outbreak began in December 2017 and has now sickened 6,394 people, 42 of them fatally.
Oct 5 WHO statement on cholera in Zimbabwe
Oct 5 WHO statement on cholera in Niger
Oct 4 WHO EMRO statement on cholera in Somalia

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