sábado, 18 de noviembre de 2017

New CDC resources on antibiotic use and drug resistance in food and animals

CDC takes a One Health Approach to Combat Antibiotic Resistance
New resources to improve antibiotic prescribing and use, and combat antibiotic resistance
This week, CDC observed U.S. Antibiotic Awareness Week, a national effort to help fight antibiotic resistance and improve antibiotic prescribing and use. Antibiotics save lives, but any time antibiotics are used in people or animals, they can lead to the development of antibiotic resistance.
As part of the awareness week, CDC released several new resources, including:
  • Be Antibiotics AwareA new initiative, Be Antibiotics Aware, with new tools for healthcare professionals and consumers around antibiotic prescribing and use in human medicine.
  • A new video about antibiotic resistance and food. CDC estimates that more than 400,000 U.S. residents become ill with infections caused by antibiotic-resistant foodborne bacteria every year. People who are infected with antibiotic-resistant bacteria may experience more severe illness, including hospitalization and death, because these infections can be harder to treat.
  • A new video on CDC’s role in the National Antimicrobial Resistance Monitoring System (NARMS), which helps protect public health by providing information about emerging resistance threats, how resistance spreads, and how resistant infections differ from other infections.
  • A new webpage encouraging pet owners and veterinary professionals to use antibiotics wisely in pets. Antibiotics are necessary to protect the health of people and animals, including pets.
CDC works daily to raise awareness about the importance of appropriate antibiotic prescribing and use to prevent antibiotic resistance. We all have a role to play, and together we can make a difference.
To learn more, visit:

VYZULTA: New Drug Trials Snapshot Posted

A new  DRUG TRIALS SNAPSHOT is now available. 
VYZULTA is a drug for reducing elevated intraocular pressure (IOP) when the pressure inside the eye is too high.
One drop of VYZULTA is applied once daily, in the evening, in the affected eye.
See more  Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.

Drug Trials Snapshots: Vyzulta

The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the VYZULTA Prescribing Information for complete information.
VYZULTA (latanoprostene bunod) 
Bausch & Lomb Inc. 
Approval date: November 2, 2017


What is the drug for?

VYZULTA is a drug for reducing elevated intraocular pressure (IOP) when the pressure inside the eye is too high.

How is this drug used?

One drop of VYZULTA is applied once daily, in the evening, in the affected eye.

What are the benefits of this drug?

VYZULTA lowers the intraocular pressure.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: VYZULTA worked similarly in men and women.
  • Race: VYZULTA worked similarly in White and Black or African American participants. The number of participants in other races was limited, therefore differences in response could not be determined.
  • Age: VYZULTA worked similarly in participants above and below age 65.

What are the possible side effects?

The most common side effects are conjunctival (eye) redness, eye irritation and eye discomfort (pain).
VYZULTA may cause the iris (colored part of the eye) to become darker in color.

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The occurrence of side effects was similar in White and Black or African American participants. The number of participants in other races was limited, therefore differences in side effects among other races could not be determined.
  • Age: The occurrence of side effects was similar in participants above and below age 65.


Who participated in the clinical trials?

The FDA approved VYZULTA based on evidence from two clinical trials that enrolled 840 participants with open angle glaucoma or ocular hypertension. The trials were conducted in the United States, United Kingdom, Germany, Italy, Bulgaria, Czech Republic and Japan.
Figure 1 summarizes how many men and women were enrolled in the clinical trials.
Figure 1. Baseline Demographics by Sex
(Alt-Tag: Pie chart summarizing how many men and women were in the clinical trials. In total, 350 men (42%) and  490 women (58%) participated in the clinical trials.)
Clinical Trial Data
Figure 2 summarizes the percentage of participants by race in the clinical trials.

Figure 2. Baseline Demographics by Race

(Alt-Tag: Pie chart summarizing the percentage of patients by race in the clinical trials. In total, 623 White (74%), 204 Black or African American (24%), 8 Asians (1%), and 3 Other (<1%), participated in the clinical trials
Clinical Trial Data
 Table 1. Baseline Demographics by Race
RaceNumber of ParticipantsPercentage
Black or African American20424%
All Other3less than 1%
Figure 3 summarizes the percentage of participants by age that were enrolled in the clinical trials
Figure 3 Baseline Demographics by Age
Alt-Tag: Pie charts summarizing how many individuals of certain age groups were in the clinical trial. In total, 402 patients  were younger than 65 years (48%), and  438 patients were  65 years and older (52%)
Clinical Trial Data

How were the trials designed?

There were two trials that evaluated the benefits and side effects of VYZULTA.
In each trial, participants were randomly assigned to receive either VYZULTA or an approved drug timolol (ophthalmic solution) every day for 3 months. Neither the participants nor the health care providers knew which treatment was being given until after the trials were completed.
The benefit of VYZULTA was measured by decrease in IOP in comparison to timolol after 3 months of treatment.
The side effects were evaluated both during the same three months’ period when the benefits were being evaluated and afterward at which point all the participants (VYZULTA treated and timolol treated) were moved to VYZULTA treatment only for an additional 3 to 9 months. This way, the side effects of VYZULTA could be evaluated in larger number of participants and for longer period.


CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

VYZULTA Prescribing Information

New Articles From Orphanet Journal of Rare Diseases

New Articles For BioMed Central:

Orphanet Journal of Rare Diseases

The following new articles have just been published in Orphanet Journal of Rare Diseases


Identification of GAA variants through whole exome sequencing targeted to a cohort of 606 patients with unexplained limb-girdle muscle weakness

Katherine Johnson, Ana Töpf, Marta Bertoli, Lauren Phillips, Kristl G. Claeys, Vidosava Rakocevic Stojanovic, Stojan Perić, Andreas Hahn, Paul Maddison, Ela Akay, Alexandra E. Bastian, Anna Łusakowska, Anna Kostera-Pruszczyk, Monkol Lek, Liwen Xu, Daniel G. MacArthur…
Orphanet Journal of Rare Diseases 2017, 12:173 | Published on: 17 November 2017

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Hibernating ground squirrels provide clues to new stroke treatments | National Institutes of Health (NIH)

Hibernating ground squirrels provide clues to new stroke treatments | National Institutes of Health (NIH)

National Institutes of Health (NIH) - Turning Discovery into Health



Hibernating ground squirrels provide clues to new stroke treatments

Multi-step screening process leads to molecule that may protect brain cells.
In the fight against brain damage caused by stroke, researchers have turned to an unlikely source of inspiration: hibernating ground squirrels.
While the animals’ brains experience dramatically reduced blood flow during hibernation, just like human patients after a certain type of stroke, the squirrels emerge from their extended naps suffering no ill effects. Now, a team of NIH-funded scientists has identified a potential drug that could grant the same resilience to the brains of ischemic stroke patients by mimicking the cellular changes that protect the brains of those animals. The study was published in The FASEB Journal, the official journal of the Foundation of American Societies for Experimental Biology.
“For decades scientists have been searching for an effective brain-protecting stroke therapy to no avail. If the compound identified in this study successfully reduces tissue death and improves recovery in further experiments, it could lead to new approaches for preserving brain cells after an ischemic stroke,” said Francesca Bosetti, Ph.D., Pharm.D., program director at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS).
An ischemic stroke occurs when a clot cuts off blood flow to part of the brain, depriving those cells of oxygen and nutrients like the blood sugar glucose that they need to survive. Nearly 800,000 Americans experience a stroke every year and 87 percent of those are ischemic strokes.
Currently, the only way to minimize stroke-induced cell death is to remove the clot as soon as possible. A treatment to help brain cells survive a stroke-induced lack of oxygen and glucose could dramatically improve patient outcomes, but no such neuroprotective agents for stroke patients exist.
Recently, researchers led by John Hallenbeck, M.D., an NINDS senior investigator and co-senior author of the study, found that a cellular process called SUMOylation goes into overdrive in a certain species of ground squirrel during hibernation. Dr. Hallenbeck suspected this was how the animals’ brains survived the reduced blood flow caused by hibernation, and subsequent experiments in cells and mice confirmed his suspicions.
“If we could only turn on the process hibernators appear to use to protect their brains, we could help protect the brain during a stroke and ultimately help people recover,” said Joshua Bernstock, a graduate student in Dr. Hallenbeck’s lab and the study’s first author.
SUMOylation occurs when an enzyme attaches a molecular tag called a Small Ubiquitin-like Modifier (SUMO) to a protein, altering its activity and location in the cell. Other enzymes called SUMO-specific proteases (SENPs) can then detach those tags, thereby decreasing SUMOylation. In the current study, Bernstock and his colleagues teamed up with researchers from the NIH’s National Center for Advancing Translational Sciences (NCATS) to examine whether any of over 4,000 molecules from the NCATS small molecule collections could boost SUMOylation by blocking a SENP called SENP2, which would theoretically protect cells from a shortage of life-sustaining substances.
The researchers first used an automated process to examine whether the compounds prevented SENP2 from severing the connection between a tiny metal bead and an artificial SUMO protein created in the lab of Wei Yang, Ph.D., the study’s other senior author and an associate professor at Duke University in Durham, NC. This system, along with computer modeling and further tests performed both in and outside of cells, whittled the thousands of candidate molecules down to eight that could bind to SENP2 in cells and were non-toxic. Two of those – ebselen and 6-thioguanine – were then found to both boost SUMOylation in rat cells and keep them alive in the absence of oxygen and glucose.
A final experiment showed that ebselen boosted SUMOylation in the brains of healthy mice more than a control injection. 6-thioguanine was not tested because it is a chemotherapy drug with side effects that make it unsuitable as a potential stroke treatment. The researchers now plan to test whether ebselen can protect the brains of animal models of stroke.
Because SUMOylation affects a variety of molecules, Bernstock believes his group’s approach could inspire similar attempts to treat neurological conditions by targeting pathways with wide-ranging effects. He also hopes it will prompt others to look to natural models, as he and Dr. Hallenbeck did with the ground squirrel.
“As a physician-scientist, I really like to work on projects that have clear relevance for patients,” Bernstock said. “I always want outcomes that can lend themselves to new therapeutics for people who are in need.”
The study was funded by the Intramural Research Programs of the NINDS and NCATS, NINDS grant NS099590, the NIH-OxCam Fellowship, and the American Heart Association. 
The National Institute of Neurological Disorders and Stroke (NINDS) is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.
About the National Center for Advancing Translational Sciences (NCATS): NCATS conducts and supports research on the science and operation of translation – the process by which interventions to improve health are developed and implemented – to allow more treatments to get to more patients more quickly. For more information about how NCATS is improving health through smarter science, visit https://ncats.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH…Turning Discovery Into Health®


Bernstock et al. Quantitative high-throughput screening identifies cytoprotective molecules that enhance SUMO-conjugation via the inhibition of SUMO-specific protease (SENP)2. The FASEB Journal. November 16, 2017. doi: 10.1096/fj.201700711R. 

Ahead of Print -Ceftriaxone-Resistant Neisseria gonorrhoeae, Canada, 2017 - Volume 24, Number 2—February 2018 - Emerging Infectious Disease journal - CDC

Ahead of Print -Ceftriaxone-Resistant Neisseria gonorrhoeae, Canada, 2017 - Volume 24, Number 2—February 2018 - Emerging Infectious Disease journal - CDC

Volume 24, Number 2—February 2018


Ceftriaxone-Resistant Neisseria gonorrhoeae, Canada, 2017

Brigitte LefebvreComments to Author , Irene Martin, Walter Demczuk, Lucie Deshaies, Stéphanie Michaud, Annie-Claude Labbé, Marie-Claude Beaudoin, and Jean Longtin
Author affiliations: Institut National de Santé Publique du Québec, Québec, Québec, Canada (B. Lefebvre, J. Longtin)Public Health Agency of Canada, Winnipeg, Manitoba, Canada (I. Martin, W. Demczuk)Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale, Québec (L. Deshaies)Direction de Santé Publique du Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale, Québec (S. Michaud)Université de Montréal, Québec (A.-C. Labbé)Centre de Recherche en Infectiologie, Université Laval, Québec (M.-C. Beaudoin, J. Longtin)


We identified a ceftriaxone-resistant Neisseria gonorrhoeae isolate in a patient in Canada. This isolate carried the penA-60 allele, which differs substantially from its closest relative, mosaic penA XXVII (80% nucleotide identity). Epidemiologic and genomic data suggest spread from Asia. Antimicrobial susceptibility surveillance helps prevent spread of highly resistant N. gonorrhoeae strains.
Ceftriaxone is one of the last remaining treatments available for gonorrhea and a component of the recommended dual therapy with azithromycin in Canada (1). As of October 15, 2017, only 5 ceftriaxone-resistant Neisseria gonorrhoeae isolates had been reported worldwide (MIC range 0.5–2 mg/L) (26). The highest ceftriaxone MIC reported in Canada was 0.25 mg/L, representing only 0.45% (49/10,805) of all N. gonorrhoeae isolates tested during 2010‒2016 (7). We describe ceftriaxone-resistant N. gonorrhoeae isolated in Canada.

The Study

An asymptomatic 23-year-old woman had a positive N. gonorrhoeae nucleic acid amplification test (NAAT) result (Cobas 4800 CTNG; Roche Diagnostics Canada, Laval, Canada) on January 17, 2017, obtained as part of a screening for sexually transmitted infections (STIs). Upon receiving the result, a physician instructed the patient to follow-up with the STI clinic to have proper counselling. She visited on January 24 and obtained a prescription of single-dose cefixime 800 mg and azithromycin 1 g (recommended therapy according to Québec STI Treatment Guidelines) (8). Because the patient was from a low-prevalence population, the healthcare provider decided to perform a genital gonorrhea culture. The culture was positive for N. gonorrhoeae (no. GC063564/47707), thus confirming the positive NAAT result.
Because antimicrobial susceptibility testing (Etest, bioMérieux, Marcy l’Etoile, France) demonstrated nonsusceptibility of the isolate to ceftriaxone and cefixime but susceptibility to azithromycin, a second follow-up visit was requested by the practitioner. The second visit occurred February 7, 2017, and the patient was then prescribed empirically a single 2-g dose of azithromycin. Tests of cure by NAAT and cervical culture were performed during this visit and were negative for N. gonorrhoeae, indicating a successful initial treatment with cefixime and azithromycin administered 14 days earlier.
The patient reported a month-long sexual relationship 60 days before the STI screening. The partner was assessed by clinical examination and screening tests and treated with cefixime 800 mg and azithromycin 1 g on January 27, 2017. He was asymptomatic and his urinary NAAT screening result was negative for N. gonorrhoeae. He did not have sex with men or a sex worker but did report unprotected sexual activity during a trip to China and Thailand in November 2016, before his relationship with the patient in this case study. Information about antimicrobial drug use during his trip to Asia was not available. He was followed up February 2017, and NAAT test results of his urine and pharyngeal specimens were again both negative for gonorrhea. Public health professionals also contacted the case study patient’s next-to-last partner (5 months earlier), and his screening result was also negative for N. gonorrhoeae.
The bacterial isolate from our patient was confirmed to be N. gonorrhoeae by API NH (bioMérieux), VITEK (bioMérieux), matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (bioMérieux), and whole-genome sequencing. Antimicrobial susceptibilities for isolate GC063564 were confirmed by using the agar dilution method according to the Clinical and Laboratory Standards Institute protocol (9). The strain was resistant to ceftriaxone (MIC 1 mg/L), cefixime (MIC 2 mg/L), ciprofloxacin (MIC 32 mg/L), and tetracycline (MIC 4 mg/L) and susceptible to azithromycin (MIC 0.5 mg/L). The Clinical and Laboratory Standards Institute does not have a resistance breakpoint for cefixime or ceftriaxone but defines susceptibility at an MIC <0.25 mg/L. The European Committee on Antimicrobial Susceptibility Testing defines cefixime and ceftriaxone resistance at an MIC >0.125 mg/L (10), and the World Health Organization defines decreased susceptibility to cefixime as an MIC ≥0.25 mg/L and to ceftriaxone an MIC ≥0.125 mg/L (11). Although the defined resistance breakpoint is not consistent among these organizations, a ceftriaxone MIC 1 mg/L has been previously reported as resistance (2,6).
We performed molecular typing in silico using whole-genome sequence data (BioProject PRJNA415047). We sequenced the isolate with the Illumina MiSeq platform (Illumina, San Diego, CA, USA) and used genomic quality, assembly, and annotation pipelines as previously described (12). The multilocus sequence type (ST) of GC063564 was ST1903, and N. gonorrhoeae multiantigen sequence type (MAST) was ST1614. Using a novel antimicrobial genomic sequence analytic tool called NG-STAR (N. gonorrhoeae Sequence Typing for Antimicrobial Resistance) (13), we identified the isolate GC063564 as NG-STAR ST233, which contains a mosaic penA allele, mtrR-35A deletion, porB G120K/A121D, ponA L421P, gyrA S91F/D94A, parC S87R, and no 23S rRNA A2059/C2611 mutations. The GC063564 isolate also had an rpsJ V57M mutation, and tetM was not detected.
The molecular antimicrobial resistance profile corresponds to the MICs determined phenotypically (13). The multilocus sequence type (ST1903) and mosaic penA allele (penA-60) of this isolate from Canada were identical to those of the ceftriaxone- and multidrug-resistant N. gonorrhoeae FC428 isolated in 2015 in Japan (14). PenA-60 has a mosaic penicillin-binding protein 2 structure with 2 key mutations (A311V and T483S) that confer ceftriaxone resistance. PenA-60 differs substantially from previously described penA types (5), resembling only 80% of the closest-related mosaic allele penA-XXVII. Bacterial isolates GC063564 and FC428 had identical porB1b NG-MAST alleles but different tbpB alleles (GC063564 had tbpB-33; FC428 had tpbB-21), resulting in different N. gonorrhoeae MAST profiles (ST-1614 for GC063564 and ST-3435 for FC428). The variation in the N. gonorrhoeaeMAST types between the 2 isolates collected 2 years apart is not unexpected, considering the highly recombinant nature of the N. gonorrhoeae genome (15).


We identified a ceftriaxone-resistant N. gonorrhoeae isolate in Canada that contained the penA-60 allele formerly reported in Japan in 2015. Epidemiologic information suggests international spread of a penA allele associated with high-level ceftriaxone resistance. Antimicrobial susceptibility surveillance successfully identified this novel isolate introduced into Canada and prompted public health officials to rapidly conduct an investigation to prevent further spread in the community. In an era of multidrug-resistant gonorrhea, ongoing antimicrobial susceptibility surveillance of N. gonorrhoeae is critical to support treatment guidelines, public health intervention, and protection.
Dr. Lefebvre is the head of the Antibiotics Resistance Department at the Laboratoire de Santé Publique du Québec, Québec, Canada, and in charge of the provincial surveillance programs, which investigates invasive Neisseria meningitidisStreptococcus pneumoniae, and Haemophilus influenzae infections and monitors for resistance of Neisseria gonorrhoeae and carbapenemase-producing enterobacteria. Her research interests includes antimicrobial drug resistance of pathogenic agents of public health interest.


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  2. Cámara JSerra JAyats JBastida TCarnicer-Pont DAndreu Aet al. Molecular characterization of two high-level ceftriaxone-resistant Neisseria gonorrhoeae isolates detected in Catalonia, Spain. J Antimicrob Chemother2012;67:185860DOIPubMed
  3. Deguchi TYasuda MHatazaki KKameyama KHorie KKato Tet al. New clinical strain of Neisseria gonorrhoeae with decreased susceptibility to ceftriaxone, Japan. Emerg Infect Dis2016;22:1424DOIPubMed
  4. Lahra MMRyder NWhiley DMA new multidrug-resistant strain of Neisseria gonorrhoeae in Australia. N Engl J Med2014;371:18501DOIPubMed
  5. Ohnishi MGolparian DShimuta KSaika THoshina SIwasaku Ket al. Is Neisseria gonorrhoeae initiating a future era of untreatable gonorrhea?: detailed characterization of the first strain with high-level resistance to ceftriaxone. Antimicrob Agents Chemother2011;55:353845DOIPubMed
  6. Unemo MGolparian DNicholas ROhnishi MGallay ASednaoui PHigh-level cefixime- and ceftriaxone-resistant Neisseria gonorrhoeae in France: novel penA mosaic allele in a successful international clone causes treatment failure. Antimicrob Agents Chemother2012;56:127380DOIPubMed
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  8. Institut National d'excellence en Santé et en Services Sociaux. Guide de traitement pharmacologique sur les ITSS. Infection à Chlamydia trachomatiset infection à Neisseria gonorrhoeae2015 [cited 2017 Oct 23]. http://www.inesss.qc.ca/fileadmin/doc/INESSS/Outils/Guides_ITSS/Guide_ITSS-Chlamydia_gonorrhoeae_majdec2015_.pdf
  9. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing; twenty-seven informational supplement (M100–S27). Wayne (PA): The Institute; 2017.
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  11. World Health Organization. Global action plan to control the spread and impact of antimicrobial resistance in Neisseria gonorrhoeae2012 [cited 2017 Oct 23]. http://www.who.int/reproductivehealth/publications/rtis/9789241503501/en/
  12. Demczuk WLynch TMartin IVan Domselaar GGraham MBharat Aet al. Whole-genome phylogenomic heterogeneity of Neisseria gonorrhoeaeisolates with decreased cephalosporin susceptibility collected in Canada between 1989 and 2013. J Clin Microbiol2015;53:191200DOIPubMed
  13. Demczuk WSidhu SUnemo MWhiley DMAllen VGDillon JRet al. Neisseria gonorrhoeae sequence typing for antimicrobial resistance, a novel antimicrobial resistance multilocus typing scheme for tracking global dissemination of N. gonorrhoeae strains. J Clin Microbiol2017;55:145468DOIPubMed
  14. Nakayama SShimuta KFurubayashi KKawahata TUnemo MOhnishi MNew ceftriaxone- and multidrug-resistant Neisseria gonorrhoeae strain with a novel mosaic penA gene isolated in Japan. Antimicrob Agents Chemother2016;60:433941DOIPubMed
  15. De Silva DPeters JCole KCole MJCresswell FDean Get al. Whole-genome sequencing to determine transmission of Neisseria gonorrhoeae: an observational study. Lancet Infect Dis2016;16:1295303DOIPubMed
Suggested citation for this article: Lefebvre B, Martin I, Demczuk W, Deshaies L, Michaud S, Labbé A-C, et al. Ceftriaxone-resistant Neisseria gonorrhoeae, Canada, 2017. Emerg Infect Dis. 2018 Feb [date cited]. http://doi.org/10.3201/eid2402.171756

DOI: 10.3201/eid2402.171756