CARB-X Funding Opportunities for Innovations in Antimicrobial Resistance on 12th of November, 2019

CARB-X

 

The Centre for Cellular and Molecular Platforms - C-CAMP, is delighted to let you know that fourth round of CARB-X funding, 2019 for product developers, researchers and innovators around the world working in various domains of Antimicrobial Resistance will be open from 12th of November to 19th of November, 2019.

 

C-CAMP, as one of the Global Accelerator Partners of CARB-X is proposing a webinar to provide information on CARB-X Funding Opportunities for Innovations in Antimicrobial Resistance on 12th of November, 2019. If you are keen to attend, please do let us know by filling up the form http://bit.ly/12novCARB-X or write to us at This email address is being protected from spambots. You need JavaScript enabled to view it. details for the webinar is as follows:

 

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Potential for improved survival of newborns in sub-Saharan Africa from affordable, non-invasive point-of-care devices

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Above photo provided by Professor William Macharia

 

Potential for improved survival of newborns in sub-Saharan Africa from affordable, non-invasive point-of-care devices   By William M Macharia

 

An estimated 1 million newborns die in sub-Saharan Africa annually, contributing to 50% of all deaths in children under the age of five. Birth asphyxia, neonatal sepsis and pneumonia are common causes of neonatal death. Especially disadvantaged are children of the poor and residents of rural and urban communities largely served by public health facilities with sub-optimal quality of services. The situation is made worse by scarcity of trained manpower (especially nurses to monitor and administer treatment), shortage of essential supplies, and low staff morale from inadequate remuneration. It is no wonder that most countries in the region failed to meet set Millennium Development Goal targets and are set to miss Sustainable Development Goal (SDG) targets unless major changes take place, and soon. A major let down was stagnation of neonatal and maternal mortality rates that has remained high throughout the years. This has to be the focus for new innovative interventions during the SDG era. Kenya Countdown 2015 case study (https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30246-2/fulltext), whose findings were launched by Kenya’s First Lady in April 2016, pointed out the importance of paying more attention to quality of care around birth and services to poor populations.

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NOVEMBER 2019 MEMBER NEWSLETTER

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Above photo, provided by Fredrik Lerneryd / Save the Children. Nakwan is only seven days old, and she has pneumonia. She will remain in the clinic under treatment until she is stable. Katilu health centre is located in Katilu, Turkana county in Northern Kenya. The centre receives around 3600 patients per month. Among those patients, around 15 are treated for pneumonia, however due to the heavy rain, they treated 34 pneumonia patients last month.

 

A COMMENT FROM THE COORDINATOR

 

This year to commemorate World Pneumonia Day on November 12, 2019, the PIN will be hosting a webinar on Pneumonia Careseeking in Asia. Please join us to learn about pneumonia careseeking behaviors from three organizations in Bangladesh, India, and Pakistan.

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WHO Practical toolkit: Antimicrobial Stewardship Programmes in Health-Care Facilities in Low- and Middle-Income Countries.

Following two years of hard work, involving international AMS experts, wide consultations and feasibility studies in LMICs, WHO is  happy to share the newly published “WHO Practical Toolkit: Antimicrobial Stewardship Programmes in Health-Care Facilities in Low- and Middle-Income Countries” view full toolkit here.

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Usability and acceptability of two automated pneumonia diagnostic aids: Findings from Ethiopia and Nepal

By Malaria Consortium. Published October 2019.

 

The Acute Respiratory Infection Diagnostic Aid (ARIDA) project introduced two automated respiratory rate counting aids in Ethiopia and Nepal to support frontline health workers to classify fast breathing: a symptom of pneumonia. This research brief discusses the usability of the devices, as well as their acceptability to frontline health workers and caregivers.

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American Society of Tropical Medicine & Hygiene (ASTMH) Annual Meeting

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2019 Annual Meeting

ASTMH 68th Annual MeetingNovember 20-24, 2019 (Wednesday through Sunday)Gaylord National Resort and Convention CenterNational Harbor, Maryland USA (adjacent to Washington, DC)

 

View full details here. 

 The ASTMH Annual Meeting draws tropical medicine and global health professionals representing academia, government, non-profits, philanthropy, NGOs, industry, military and private practice. The meeting is designed for researchers, professors, government and public health officials, military personnel, travel clinic physicians, practicing physicians in tropical medicine, students and all health care providers working in the fields of tropical medicine, hygiene and global health. The Annual Meeting is a five-day educational conference that includes four pre-meeting courses and draws approximately 4,800 attendees. 
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Multiplex Polymerase Chain Reaction Panel for Suspected Pertussis What About a Positive Mycoplasma pneumoniae Result?

By Michaël  Desjardins, Paméla Doyon-Plourde, Sarah Mousseau, Daniela Iachimov, Fabien Rallu, Caroline Quach. Published in The Journal of Pediatric Infectious Diseases. Published October 1, 2019.  

 

The use of bacterial multiplex polymerase chain reaction (PCR) in children with suspected pertussis sometimes yields unexpected positive results for Mycoplasma pneumoniae. We aimed to evaluate the clinical significance of positive M. pneumoniae results in this population. Retrospective cohort of consecutive patients with suspected pertussis tested with a bacterial multiplex PCR (including Bordetella pertussis and M. pneumoniae) between June 2015 and March 2017. Medical records were reviewed to compare demographics, clinical presentations and outcomes of patients positive for M. pneumoniae with those positive for B. pertussis and those with negative results, using multivariable logistic regression. A total of 1244 patients were included as follows: 56 (4.5%) with M. pneumoniae, 116 (9.3%) with B. pertussis and 1029 (82.7%) with negative results. Mean age was respectively 4.8 years, 6.5 years and 2.8 years (P < 0.05). Children with M. pneumoniae were less likely to present with cardinal symptoms of pertussis such as paroxysmal cough [adjusted odds ratio (OR): 0.19, 95% confidence interval (CI): 0.08–0.40) but were more likely to have fever (adjusted OR: 10.53, 95% CI: 3.54–39.49) and other nonspecific respiratory symptoms compared with children with B. pertussis. Children with M. pneumoniae had very similar clinical presentations to those with a negative PCR, but were more likely to have radiologically confirmed pneumonia (adjusted OR: 5.48, 95% CI: 2.96–9.99) and were less likely to be diagnosed with a concomitant viral infection (adjusted OR: 0.32, 95% CI: 0.07–0.99). In children with suspected pertussis, the detection of M. pneumoniae is clinically relevant. However, the impact of this finding on patients’ outcome is still unclear.

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Delayed Administration of Recombinant Plasma Gelsolin Improves Survival in a Murine Model of Penicillin-Susceptible and Penicillin-Resistant Pneumococcal Pneumonia

By Zhiping Yang, Alice Bedugnis, Susan Levinson, Mark Dinubile, Thomas Stossel, Quan Lu, Lester Kobzik. Published in The Journal of Infectious Diseases. To be published November 1, 2019.  

 

Therapy to enhance host immune defenses may improve outcomes in serious infections, especially for antibiotic-resistant pathogens. Recombinant human plasma gelsolin (rhu-pGSN), a normally circulating protein, has beneficial effects in diverse preclinical models of inflammation and injury. We evaluated delayed therapy (24–48 hours after challenge) with rhu-pGSN in a mouse model of pneumococcal pneumonia. rhu-pGSN without antibiotics increased survival and reduced morbidity and weight loss after infection with either penicillin-susceptible or penicillin-resistant pneumococci (serotypes 3 and 14, respectively). rhu-pGSN improves outcomes in a highly lethal pneumococcal pneumonia model when given after a clinically relevant delay, even in the setting of antimicrobial resistance.

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Preventing Bloodstream Infections and Death in Zambian Neonates: Impact of a Low-cost Infection Control Bundle

By Lawrence Mwananyanda, Cassandra Pierre, James Mwansa, Carter Cowden, A Russell Localio, Monica L Kapasa, Sylvia Machona, Chileshe Lukwesa Musyani, Moses M Chilufya, Gertrude Munanjala, Angela Lyondo, Matthew A Bates, Susan E Coffin, Davidson H Hamer. Published in Clinical Infectious Diseases. To be published October 15, 2019.   

 

Sepsis is a leading cause of neonatal mortality in low-resource settings. As facility-based births become more common, the proportion of neonatal deaths due to hospital-onset sepsis has increased. We conducted a prospective cohort study in a neonatal intensive care unit in Zambia where we implemented a multifaceted infection prevention and control (IPC) bundle consisting of IPC training, text message reminders, alcohol hand rub, enhanced environmental cleaning, and weekly bathing of babies ≥1.5 kg with 2% chlorhexidine gluconate. Hospital-associated sepsis, bloodstream infection (BSI), and mortality (>3 days after admission) outcome data were collected for 6 months prior to and 11 months after bundle implementation. Most enrolled neonates had a birth weight ≥1.5 kg (2131/2669 [79.8%]). Hospital-associated mortality was lower during the intervention than baseline period (18.0% vs 23.6%, respectively). Total mortality was lower in the intervention than prior periods. Half of enrolled neonates (50.4%) had suspected sepsis; 40.8% of cultures were positive. Most positive blood cultures yielded a pathogen (409/549 [74.5%]), predominantly Klebsiella pneumoniae (289/409 [70.1%]). The monthly rate and incidence density rate of suspected sepsis were lower in the intervention period for all birth weight categories, except babies weighing <1.0 kg. The rate of BSI with pathogen was also lower in the intervention than baseline period. A simple IPC bundle can reduce sepsis and death in neonates hospitalized in high-risk, low-resource settings. Further research is needed to validate these findings in similar settings and to identify optimal implementation strategies for improvement and sustainability.

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The Association of Antibiotic Stewardship With Fluoroquinolone Prescribing in Michigan Hospitals: A Multi-hospital Cohort Study

By Valerie M Vaughn, Tejal Gandhi, Anna Conlon, Vineet Chopra, Anurag N Malani, Scott A Flanders. Published in Clinical Infectious Diseases. To be published October 15, 2019.   

 

Fluoroquinolones increase the risk of Clostridioides difficile infection and antibiotic resistance. Hospitals often use pre-prescription approval or prospective audit and feedback to target fluoroquinolone prescribing. Whether these strategies impact aggregate fluoroquinolone use is unknown. This study is a 48-hospital, retrospective cohort of general-care, medical patients hospitalized with pneumonia or positive urine culture between December 2015–September 2017. Hospitals were surveyed on their use of pre-prescription approval and/or prospective audit and feedback to target fluoroquinolone prescribing during hospitalization (fluoroquinolone stewardship). After controlling for hospital clustering and patient factors, aggregate (inpatient and post-discharge) fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) exposure was compared between hospitals with and without fluoroquinolone stewardship. There were 11 748 patients (6820 pneumonia; 4928 positive urine culture) included at 48 hospitals. All hospitals responded to the survey: 29.2% (14/48) reported using pre-prescription approval and/or prospective audit and feedback to target fluoroquinolone prescribing. After adjustment, fluoroquinolone stewardship was associated with fewer patients receiving a fluoroquinolone (37.1% vs 48.2%; P = .01) and fewer fluoroquinolone treatment days per 1000 patients (2282 vs 3096 days/1000 patients; P = .01), driven by lower inpatient prescribing. However, most (66.6%) fluoroquinolone treatment days occurred after discharge, and hospitals with fluoroquinolone stewardship had twice as many new fluoroquinolone starts after discharge as hospitals without (15.6% vs 8.4%; P = .003). Hospital-based stewardship interventions targeting fluoroquinolone prescribing were associated with less fluoroquinolone prescribing during hospitalization, but not at discharge. To limit aggregate fluoroquinolone exposure, stewardship programs should target both inpatient and discharge prescribing.

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Effect of Age on Relative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccines Among US Medicare Beneficiaries Aged ≥65 Years

By Yun Lu, Yoganand Chillarige, Hector S Izurieta, Yuqin Wei, Wenjie Xu, Michael Lu, Heng-Ming Sung, Arnstein Lindaas, Michael Wernecke, Thomas Macurdy, Jeffrey Kelman, Richard A Forshee. Published in The Journal of Infectoius Diseases. To be published November 1, 2019.   

 

Studies have found that the high-dose influenza vaccine has a higher relative vaccine effectiveness (rve) versus standard-dose vaccines in some seasons. We evaluated the effect of age on the rve of high-dose versus standard-dose influenza vaccines among medicare beneficiaries. A 6-season retrospective cohort study from 2012 to 2018 among medicare beneficiaries aged ≥65 years was performed. Poisson regression was used to evaluate the effect of age on the rve of high-dose versus standard-dose influenza vaccines in preventing influenza-related hospitalizations.The study included >19 million vaccinated beneficiaries in a community pharmacy setting. The poisson models indicated a slightly increasing trend in rve with age in all seasons. The high-dose vaccine was more effective than standard-dose vaccines in preventing influenza-related hospital encounters (ie, influenza-related inpatient stays and emergency department visits) in the 2012–2013 (rve, 23.1%; 95% confidence interval [ci], 17.6%–28.3%), 2013–2014 (rve, 15.3%; 95% ci, 7.8%–22.3%), 2014–2015 (rve, 8.9%; 95% ci, 5.6%–12.1%), and 2016–2017 (rve, 12.6%; 95% ci, 6.3%–18.4%) seasons and was at least as effective in all other seasons. We also found that the high-dose vaccine was consistently more effective than standard-dose vaccines across all seasons for people aged ≥85 years. Similar trends were observed for influenza-related inpatient stays. The rve of high-dose versus standard-dose influenza vaccines increases with age.

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Burden of Invasive Pneumococcal Disease

By Mary Slack, Andrew Vyse, Harish Madhava, Gillian Ellsbury, Carole Czudek, Ralf-Rene Reinert, Bradford Gessner. Published in Clinical Infectious Diseases. October 15, 2019.  

 

TO THE EDITOR—We read with interest the article by Kent et al [1]. The authors note that the burden of invasive pneumococcal disease (IPD) in UK infants aged <1 year is substantial and that the incidence of IPD in this age group increased over the study period (2013–2016). Although the majority of IPD cases (369/454, 71.4%) were due to non–13-valent pneumococcal conjugate vaccine (PCV13) serotypes, disease also was caused by PCV13 (vaccine type [VT]) serotypes (85/454, 16.4%), with a limited reduction in VT IPD from 36 cases in 2013 to 28 cases in 2016. Serotype 3 was the most common VT serotype identified…

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Preference for Private Sector for Vaccination of Under-Five Children in India and Its Associated Factors: Findings from a Nationally Representative Sample

By Gokul Sarveswaran, Yuvaraj Krishnamoorthy, Manikandanesan Sakthivel, Karthiga Vijayakumar, Shanthosh Priyan, Pruthu Thekkur, Palanivel Chinnakali

Journal of Tropical Pediatrics. October 2019.

 

Understanding the factors associated with private sector preference for vaccination will help in understanding the barriers in seeking public facility and also the steps to improve public–private partnership (PPP) model. We analysed the recent National Family Health Survey-4 data (NFHS-4; 2015–16) gathered from Demographic Health Survey programme. Stratification and clustering in the sample design was accounted using svyset command. Weighted proportion of children receiving private vaccination was 10.0% (95% CI: 9.7–10.3). Children belonging to highest wealth quantile (adjusted Prevalence ratio; aPR-1.58), male child (aPR-1.07) urban area (aPR-1.11), not receiving anganwadi/Integrated Childhood Development Services (aPR-1.71) and receiving antenatal care in private sector was significantly associated with higher proportion of private vaccination. Current study showed that 1 in 10 <5 years child in India received vaccination from private health facility. Preference for private health facility was found to be influenced by higher socio-economic strata, urban area residence and seeking private health facility for antenatal and delivery services.

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Impact of H1N1 Influenza Vaccination on Child Morbidity in Guinea-Bissau

By Olga Bengård Hansen, Amabelia Rodrigues, Cesario Martins, Andreas Rieckmann, Christine Stabell Benn, Peter Aaby, Ane Bærent Fisker

Journal of Tropical Pediatrics. October 2019.

 

In addition to vaccines’ specific effects, vaccines may have non-specific effects (NSEs) altering the susceptibility to unrelated infections. Non-live vaccines have been associated with negative NSEs. In 2010, a campaign with the non-live H1N1-influenza vaccine targeted children 6–59 months in Guinea-Bissau. Bandim Health Project runs a health and demographic surveillance system site in Guinea-Bissau. Using a Cox proportional hazards model, we compared all-cause consultation rates after vs. before the campaign, stratified by participation status. Among 10 290 children eligible for the campaign, 60% had participated, 18% had not and for 22% no information was obtained. After the H1N1 campaign, the consultation rates tended to decline less for participants [HR = 0.80 (95% confidence interval, CI: 0.75; 0.85)] than for non-participants [HR = 0.68 (95% CI: 0.58; 0.79)], p = 0.06 for same effect. The decline in the vaccinated group may have been smaller than the decline in the non-vaccinated group consistent with H1N1-vaccine increasing susceptibility to unrelated infections.

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Effects of Zinc Combined with Probiotics on Antibiotic-associated Diarrhea Secondary to Childhood Pneumonia

By Rong Xiang, MS, Qing Tang, PhD, Xiu-Qi Chen, MS, Mu-Yan Li, MS, Mei-Xiong Yang, MS, Xiang Yun, MS, Li Huang, MS, Qing-Wen Shan

Journal of Tropical Pediatrics. October 2019

 

The aim of this study was to evaluate the impact of zinc combined with probiotics (Bifico) on antibiotic-associated diarrhea (AAD) secondary to pneumonia. A total of 50 patients with AAD secondary to pneumonia were randomly divided into a probiotics group (Bifico) and a combined group (zinc combined with Bifico) and 25 pneumonia patients without AAD as the control group. Serum levels of zinc, diamine oxidase (DAO) activity, D-lactate and intestinal flora [Bifidobacterium, Escherichia coli and Bifidobacterium/E. coli (B/E) ratio] were detected before and after intervention. The results showed that zinc combined with Bifico had significantly higher overall efficiency than Bifico alone for treatment of AAD secondary to pneumonia. Notably, the combined treatment increased the population of Bifidobacterium, while the number of E. coli was reduced, the B/E value was improved and DAO activity and D-lactate levels were markedly reduced. Patients with AAD secondary to pneumonia benefit from zinc supplementation of probiotic treatment.

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Paediatric sepsis

By Luregn Schlapbach. Published in Infectious Diseases. October 2019.   

 

Sepsis remains among the leading causes of childhood mortality worldwide. This review serves to highlight key areas of knowledge gain and ongoing controversies pertinent to sepsis in children. Recent findings Several recent publications describe the epidemiology of paediatric sepsis, demonstrating the impact on child health in terms of mortality and morbidity, and the shortcomings of current paediatric sepsis definitions. Although emerging data support the importance of organ dysfunction as a hallmark of paediatric sepsis, the understanding of host susceptibility to sepsis and to sepsis severity remains very limited. Next-generation sequencing and host transcriptomics have the potential to provide new insights into the pathogenesis of sepsis and may enable personalized medicine approaches. Despite good observational data indicating benefit of sepsis recognition and treatment bundles, the evidence for the individual bundle components remains scarce, implying an urgent need for large trials. Recent studies have demonstrated distinct epidemiological patterns pertinent to age groups, healthcare settings, and comorbidities in the era post meningococcal epidemics. Although sepsis quality improvement initiatives have led to substantial outcome improvements, there is urgency for innovative trials to reduce uncertainty around the optimal approach for the recognition and treatment of sepsis in children.

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Respiratory Syncytial Virus Vaccines Are We Making Progress?

By Asuncion Mejias, Rosa Rodriguez-Fernandez, Mark E. Peeples, Octavio Ramilo. Published in The Journal of Pediatric Infectious Diseases. Published October 1, 2019.  

 

Globally, it is estimated that respiratory syncytial virus (RSV) causes 33 million new episodes of acute lower respiratory tract infection (LRTI) in children <5 years of age and ≈120,000 deaths annually. In infants, RSV represents the leading cause of hospitalization worldwide and the second commonest cause of mortality in low- and middle-income countries.1,2 RSV also causes significant disease in immunocompromised hosts and the elderly and has been associated with the development of asthma.3 The increasingly recognized burden of RSV disease has made the development of a vaccine(s) a global health priority. The World Health Organization recently released a roadmap to facilitate the development and implementation of vaccines and monoclonal antibodies (mAbs) and estimated that RSV vaccination will be available in the next 5–10 years.4 This review summarizes the strategies and challenges associated with RSV vaccine development and the vaccine candidates undergoing clinical evaluation, with a focus on those geared toward the pediatric population.

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Estimated Annual Health and Cost Impact of PHiD-CV Immunization Program in Brazil

By Jorge A. Gomez, de Abreu Lopes, de Jesus Ariane, Diana C. Caceres, Javier Nieto, Eduardo Ortega-Barria. Published in The Journal of Pediatric Infectious Diseases. Published October 1, 2019.  

 

Streptococcus pneumoniae causes invasive pneumococcal disease (IPD), community-acquired pneumonia (CAP) and acute otitis media (AOM). Two higher-valent pneumococcal conjugate vaccines (PCV) are available, pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) and 13-valent PCV (PCV-13). This study estimated the economic and health impact of PHiD-CV vaccination on pneumococcal disease burden in children <5 years of age in Brazil.The disease burden prior to the PHiD-CV vaccination program was estimated from literature and databases. The effect of PHiD-CV was estimated as a reduction of 70% for IPD, 26% for CAP and 40% for AOM, based on published studies. Residual IPD cases attributable to serotype 19A were estimated using surveillance data. PCV-13 effectiveness against 19A-IPD was set at 30%–70% higher than PHiD-CV. Vaccine prices were US$12.85/dose for PHiD-CV and US$14.50/dose for PCV-13. PHiD-CV vaccination reduced IPD by 6359, CAP by 315,016 and AOM by 669,943 cases, with estimated cost savings of >US$84 million annually and US$211–22,232 per case averted depending on the outcome. Switching from PHiD-CV to PCV-13 would avoid only a few additional IPD cases at additional costs exceeding US$18 million per year (US$125,192–386,230 per IPD case averted). The PHiD-CV vaccination program in Brazil has resulted in important reductions of pneumococcal disease and substantial cost savings. Instead of switching PCVs, expanding vaccine coverage or investing in other health care interventions would be a more efficient use of resources to improve the health of the population in Brazil.

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Mycoplasma pneumoniae Carriage With De Novo Macrolide-Resistance and Breakthrough Pneumonia.

By Ammar Saadoon Alishlash, Thomas Prescott Atkinson, Charles Schlappi, Sixto M. Leal Jr, Ken B. Waites, Li Xiao. Published in Pediatrics. Published October 1, 2019.  

 

Mycoplasma pneumoniae pneumonia is prevalent in children and can be followed by upper airway carriage for months. Treatment of M pneumoniae pneumonia with macrolides is widespread and can lead to the development of macrolide resistance. The clinical consequences of chronic M pneumoniae carriage are unknown. In this article, we describe a child with acute lymphoblastic leukemia who developed macrolide-susceptible M pneumoniae pneumonia confirmed by nasopharyngeal secretions polymerase chain reaction and culture with good response to azithromycin. Five months later, the patient developed another M pneumoniae pneumonia that was diagnosed with positive macrolide-resistant M pneumoniae polymerase chain reaction and culture from the bronchoalveolar lavage. The child responded well to fluoroquinolones and eventually was discharged from the hospital. The M pneumoniae recovered from the second pneumonia is a novel strain and is genetically identical to the M pneumoniae that caused the first pneumonia, apart from the macrolide-resistance 23S ribosomal RNA gene. Both isolates are identical in both P1 (subtype 2 with a novel variant, 2bv) and multiple-locus variable number tandem repeat analysis type (53662). This is indicative of chronic M pneumoniae carriage with de novo macrolide-resistance mutation and subsequent breakthrough pneumonia that is reported for the first time here. Children with immunosuppression may be at increased risk of life-threatening macrolide-resistant pneumonia after M pneumoniae carriage. Further studies are required to evaluate the impact of this phenomenon. This will then guide strategies to limit the associated morbidity, such as testing for macrolide resistance, treatment of M pneumoniae pneumonia in high-risk children with bactericidal antibiotics (such as fluoroquinolones), and possibly eradication protocols of M pneumoniae carriage to prevent subsequent life-threatening infections.

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Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure

By Alpha A. Fowler III, Jonathon D. Truwit, R. Duncan Hite, Peter E. Morris, Christine DeWilde, Anna Priday, Bernard Fisher, Leroy R. Thacker II, Ramesh Natarajan, Donald F. Brophy, Robin Sculthorpe, Rahul Nanchal, Aamer Syed, Jamie Sturgill, Greg S. Martin, Jonathan Sevransky, Markos Kashiouris, Stella Hamman, Katherine F. Egan, Andrei Hastings, Wendy Spencer, Shawnda Tench, Omar Mehkri, James Bindas, Abhijit Duggal, Jeanette Graf, Stephanie Zellner, Lynda Yanny, Catherine McPolin, Tonya Hollrith, David Kramer, Charles Ojielo, Tessa Damm, Evan Cassity, Aleksandra Wieliczko, Matthew Halquist. Published in JAMA. October 1, 2019.

 

Experimental data suggest that intravenous vitamin C may attenuate inflammation and vascular injury associated with sepsis and acute respiratory distress syndrome (ARDS). To determine the effect of intravenous vitamin C infusion on organ failure scores and biological markers of inflammation and vascular injury in patients with sepsis and ARDS. The CITRIS-ALI trial was a randomized, double-blind, placebo-controlled, multicenter trial conducted in 7 medical intensive care units in the United States, enrolling patients (N = 167) with sepsis and ARDS present for less than 24 hours. The study was conducted from September 2014 to November 2017, and final follow-up was January 2018. Patients were randomly assigned to receive intravenous infusion of vitamin C (50 mg/kg in dextrose 5% in water, n = 84) or placebo (dextrose 5% in water only, n = 83) every 6 hours for 96 hours. The primary outcomes were change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 96 hours, and plasma biomarkers of inflammation (C-reactive protein levels) and vascular injury (thrombomodulin levels) measured at 0, 48, 96, and 168 hours. Among 167 randomized patients (mean [SD] age, 54.8 years [16.7]; 90 men [54%]), 103 (62%) completed the study to day 60. There were no significant differences between the vitamin C and placebo groups in the primary end points of change in mean modified Sequential Organ Failure Assessment score from baseline to 96 hours (from 9.8 to 6.8 in the vitamin C group [3 points] and from 10.3 to 6.8 in the placebo group [3.5 points]; difference, −0.10; 95% CI, −1.23 to 1.03; P = .86) or in C-reactive protein levels (54.1 vs 46.1 μg/mL; difference, 7.94 μg/mL; 95% CI, −8.2 to 24.11; P = .33) and thrombomodulin levels (14.5 vs 13.8 ng/mL; difference, 0.69 ng/mL; 95% CI, −2.8 to 4.2; P = .70) at 168 hours. In this preliminary study of patients with sepsis and ARDS, a 96-hour infusion of vitamin C compared with placebo did not significantly improve organ dysfunction scores or alter markers of inflammation and vascular injury. Further research is needed to evaluate the potential role of vitamin C for other outcomes in sepsis and ARDS.

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