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Article ; Online: Bacterial sensitivity to chlorhexidine and povidone-iodine antiseptics over time: a systematic review and meta-analysis of human-derived data.

Aftab, Raiyyan / Dodhia, Vikash H / Jeanes, Christopher / Wade, Ryckie G

2023 Volume 13, Issue 1, Page(s) 347

Abstract: Surgical site infection (SSI) is the most common complication of surgery, increasing healthcare costs and hospital stay. Chlorhexidine (CHX) and povidone-iodine (PVI) are used for skin antisepsis, minimising SSIs. There is concern that resistance to ... ...

Abstract	Surgical site infection (SSI) is the most common complication of surgery, increasing healthcare costs and hospital stay. Chlorhexidine (CHX) and povidone-iodine (PVI) are used for skin antisepsis, minimising SSIs. There is concern that resistance to topical biocides may be emergeing, although the potential clinical implications remain unclear. The objective of this systematic review was to determine whether the minimum bactericidal concentration (MBC) of topical preparations of CHX or PVI have changed over time, in microbes relevant to SSI. We included studies reporting the MBC of laboratory and clinical isolates of common microbes to CHX and PVI. We excluded studies using non-human samples and antimicrobial solvents or mixtures with other active substances. MBC was pooled in random effects meta-analyses and the change in MBC over time was explored using meta-regression. Seventy-nine studies were included, analysing 6218 microbes over 45 years. Most studies investigated CHX (93%), with insufficient data for meta-analysis of PVI. There was no change in the MBC of CHX to Staphylococci or Streptococci over time. Overall, we find no evidence of reduced susceptibility of common SSI-causing microbes to CHX over time. This provides reassurance and confidence in the worldwide guidance that CHX should remain the first-choice agent for surgical skin antisepsis.
MeSH term(s)	Humans ; Anti-Infective Agents, Local/pharmacology ; Povidone-Iodine/pharmacology ; Chlorhexidine/pharmacology ; Preoperative Care ; Surgical Wound Infection/prevention & control
Chemical Substances	Anti-Infective Agents, Local ; Povidone-Iodine (85H0HZU99M) ; Chlorhexidine (R4KO0DY52L)
Language	English
Publishing date	2023-01-07
Publishing country	England
Document type	Meta-Analysis ; Systematic Review ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-022-26658-1
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Diagnosing tuberculosis in the 21st century - Dawn of a genomics revolution?

Jeanes, Christopher / O'Grady, Justin

International journal of mycobacteriology

2016 Volume 5, Issue 4, Page(s) 384–391

Abstract: Tuberculosis (TB) ranks alongside HIV as the leading cause of death worldwide, killing 1.5million people in 2014. Traditional laboratory techniques do not provide sufficiently rapid results to inform clinicians on appropriate treatment, especially in the ...

Abstract	Tuberculosis (TB) ranks alongside HIV as the leading cause of death worldwide, killing 1.5million people in 2014. Traditional laboratory techniques do not provide sufficiently rapid results to inform clinicians on appropriate treatment, especially in the face of increasingly prevalent drug-resistant TB. Rapid molecular methods such as PCR and LAMP are vital tools in the fight against TB, however, rapid advances in next generation sequencing (NGS) technology are allowing increasingly rapid and accurate sequencing of entire bacterial genomes at ever decreasing cost, providing unprecedented depth of information. These advances mean NGS stands to revolutionise the diagnosis and epidemiological study of Mycobacterium tuberculosis infection. This review focuses on current applications of NGS for TB diagnosis including sequencing cultured isolates to predict drug resistance and, more desirably, direct diagnostic metagenomic sequencing of clinical samples. Also discussed is the potential impact of NGS on the epidemiological study of TB and some of the key challenges that need to be overcome to enable this promising technology to be translated into routine use.
MeSH term(s)	Genomics/methods ; High-Throughput Nucleotide Sequencing/methods ; High-Throughput Nucleotide Sequencing/statistics & numerical data ; Humans ; Molecular Diagnostic Techniques/methods ; Mycobacterium tuberculosis/genetics ; Mycobacterium tuberculosis/isolation & purification ; Tuberculosis/diagnosis
Language	English
Publishing date	2016-12-08
Publishing country	Netherlands
Document type	Journal Article ; Review
ISSN	2212-554X
ISSN (online)	2212-554X
DOI	10.1016/j.ijmyco.2016.11.028
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Article ; Online: The predictive role of symptoms in COVID-19 diagnostic models: A longitudinal insight.

Bird, Olivia / Galiza, Eva P / Baxter, David Neil / Boffito, Marta / Browne, Duncan / Burns, Fiona / Chadwick, David R / Clark, Rebecca / Cosgrove, Catherine A / Galloway, James / Goodman, Anna L / Heer, Amardeep / Higham, Andrew / Iyengar, Shalini / Jeanes, Christopher / Kalra, Philip A / Kyriakidou, Christina / Bradley, Judy M / Munthali, Chigomezgo /

Minassian, Angela M / McGill, Fiona / Moore, Patrick / Munsoor, Imrozia / Nicholls, Helen / Osanlou, Orod / Packham, Jonathan / Pretswell, Carol H / San Francisco Ramos, Alberto / Saralaya, Dinesh / Sheridan, Ray P / Smith, Richard / Soiza, Roy L / Swift, Pauline A / Thomson, Emma C / Turner, Jeremy / Viljoen, Marianne Elizabeth / Heath, Paul T / Chis Ster, Irina

Epidemiology and infection

2024 Volume 152, Page(s) e37

Abstract: To investigate the symptoms of SARS-CoV-2 infection, their dynamics and their discriminatory power for the disease using longitudinally, prospectively collected information reported at the time of their occurrence. We have analysed data from a large ... ...

Abstract	To investigate the symptoms of SARS-CoV-2 infection, their dynamics and their discriminatory power for the disease using longitudinally, prospectively collected information reported at the time of their occurrence. We have analysed data from a large phase 3 clinical UK COVID-19 vaccine trial. The alpha variant was the predominant strain. Participants were assessed for SARS-CoV-2 infection via nasal/throat PCR at recruitment, vaccination appointments, and when symptomatic. Statistical techniques were implemented to infer estimates representative of the UK population, accounting for multiple symptomatic episodes associated with one individual. An optimal diagnostic model for SARS-CoV-2 infection was derived. The 4-month prevalence of SARS-CoV-2 was 2.1%; increasing to 19.4% (16.0%-22.7%) in participants reporting loss of appetite and 31.9% (27.1%-36.8%) in those with anosmia/ageusia. The model identified anosmia and/or ageusia, fever, congestion, and cough to be significantly associated with SARS-CoV-2 infection. Symptoms' dynamics were vastly different in the two groups; after a slow start peaking later and lasting longer in PCR+ participants, whilst exhibiting a consistent decline in PCR- participants, with, on average, fewer than 3 days of symptoms reported. Anosmia/ageusia peaked late in confirmed SARS-CoV-2 infection (day 12), indicating a low discrimination power for early disease diagnosis.
MeSH term(s)	Humans ; Ageusia ; Anosmia/epidemiology ; Anosmia/etiology ; COVID-19/diagnosis ; COVID-19 Testing ; COVID-19 Vaccines ; Longitudinal Studies ; SARS-CoV-2 ; Clinical Trials, Phase III as Topic
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2024-01-22
Publishing country	England
Document type	Journal Article
ZDB-ID	632982-2
ISSN	1469-4409 ; 0950-2688
ISSN (online)	1469-4409
ISSN	0950-2688
DOI	10.1017/S0950268824000037
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Article ; Online: Nanopore metagenomics enables rapid clinical diagnosis of bacterial lower respiratory infection.

Charalampous, Themoula / Kay, Gemma L / Richardson, Hollian / Aydin, Alp / Baldan, Rossella / Jeanes, Christopher / Rae, Duncan / Grundy, Sara / Turner, Daniel J / Wain, John / Leggett, Richard M / Livermore, David M / O'Grady, Justin

Nature biotechnology

2019 Volume 37, Issue 7, Page(s) 783–792

Abstract: The gold standard for clinical diagnosis of bacterial lower respiratory infections (LRIs) is culture, which has poor sensitivity and is too slow to guide early, targeted antimicrobial therapy. Metagenomic sequencing could identify LRI pathogens much ... ...

Abstract	The gold standard for clinical diagnosis of bacterial lower respiratory infections (LRIs) is culture, which has poor sensitivity and is too slow to guide early, targeted antimicrobial therapy. Metagenomic sequencing could identify LRI pathogens much faster than culture, but methods are needed to remove the large amount of human DNA present in these samples for this approach to be feasible. We developed a metagenomics method for bacterial LRI diagnosis that features efficient saponin-based host DNA depletion and nanopore sequencing. Our pilot method was tested on 40 samples, then optimized and tested on a further 41 samples. Our optimized method (6 h from sample to result) was 96.6% sensitive and 41.7% specific for pathogen detection compared with culture and we could accurately detect antibiotic resistance genes. After confirmatory quantitative PCR and pathobiont-specific gene analyses, specificity and sensitivity increased to 100%. Nanopore metagenomics can rapidly and accurately characterize bacterial LRIs and might contribute to a reduction in broad-spectrum antibiotic use.
MeSH term(s)	Anti-Bacterial Agents/pharmacology ; Bacteria/drug effects ; Bacteria/genetics ; Bacteria/isolation & purification ; Bronchitis/diagnosis ; Bronchitis/microbiology ; DNA, Bacterial/genetics ; Drug Resistance, Bacterial/genetics ; Genome, Bacterial ; High-Throughput Nucleotide Sequencing/methods ; Humans ; Metagenomics/methods ; Nanopores ; Pilot Projects ; Pneumonia, Bacterial/diagnosis ; Pneumonia, Bacterial/microbiology ; Sensitivity and Specificity
Chemical Substances	Anti-Bacterial Agents ; DNA, Bacterial
Language	English
Publishing date	2019-06-24
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1311932-1
ISSN	1546-1696 ; 1087-0156
ISSN (online)	1546-1696
ISSN	1087-0156
DOI	10.1038/s41587-019-0156-5
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Article ; Online: Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial.

Heath, Paul T / Galiza, Eva P / Baxter, David Neil / Boffito, Marta / Browne, Duncan / Burns, Fiona / Chadwick, David R / Clark, Rebecca / Cosgrove, Catherine A / Galloway, James / Goodman, Anna L / Heer, Amardeep / Higham, Andrew / Iyengar, Shalini / Jeanes, Christopher / Kalra, Philip A / Kyriakidou, Christina / Bradley, Judy M / Munthali, Chigomezgo /

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2022 Volume 76, Issue 3, Page(s) 398–407

Abstract: Background: The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against coronavirus disease 2019 (COVID-19) in a phase 3, randomized, observer-blinded, placebo-controlled trial in the United Kingdom. The protocol was amended ... ...

Abstract	Background: The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against coronavirus disease 2019 (COVID-19) in a phase 3, randomized, observer-blinded, placebo-controlled trial in the United Kingdom. The protocol was amended to include a blinded crossover. Data to the end of the placebo-controlled phase are reported. Methods: Adults aged 18-84 years received 2 doses of NVX-CoV2373 or placebo (1:1) and were monitored for virologically confirmed mild, moderate, or severe COVID-19 (onset from 7 days after second vaccination). Participants who developed immunoglobulin G (IgG) against nucleocapsid protein but did not show symptomatic COVID-19 were considered asymptomatic. Secondary outcomes included anti-spike (S) IgG responses, wild-type virus neutralization, and T-cell responses. Results: Of 15 185 participants, 13 989 remained in the per-protocol efficacy population (6989 NVX-CoV2373, 7000 placebo). At a maximum of 7.5 months (median, 4.5) postvaccination, there were 24 cases of COVID-19 among NVX-CoV2373 recipients and 134 cases among placebo recipients, a vaccine efficacy of 82.7% (95% confidence interval [CI], 73.3%-88.8%). Vaccine efficacy was 100% (95% CI, 17.9%-100.0%) against severe disease and 76.3% (95% CI, 57.4%-86.8%) against asymptomatic disease. High anti-S and neutralization responses to vaccination were evident, together with S-protein-specific induction of interferon-γ secretion in peripheral blood T cells. Incidence of serious adverse events and adverse events of special interest were similar between groups. Conclusions: A 2-dose regimen of NVX-CoV2373 conferred a high level of ongoing protection against asymptomatic, symptomatic, and severe COVID-19 through >6 months postvaccination. A gradual decrease of protection suggests that a booster may be indicated. Clinical trials registration: EudraCT, 2020-004123-16.
MeSH term(s)	Adult ; Humans ; COVID-19 Vaccines/adverse effects ; COVID-19/prevention & control ; SARS-CoV-2 ; Vaccines, Synthetic/adverse effects ; Immunoglobulin G ; Immunogenicity, Vaccine ; Double-Blind Method ; Antibodies, Viral
Chemical Substances	NVX-CoV2373 adjuvated lipid nanoparticle (2SCD8Q63PF) ; COVID-19 Vaccines ; Vaccines, Synthetic ; Immunoglobulin G ; Antibodies, Viral
Language	English
Publishing date	2022-10-06
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciac803
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Article ; Online: Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.

Heath, Paul T / Galiza, Eva P / Baxter, David N / Boffito, Marta / Browne, Duncan / Burns, Fiona / Chadwick, David R / Clark, Rebecca / Cosgrove, Catherine / Galloway, James / Goodman, Anna L / Heer, Amardeep / Higham, Andrew / Iyengar, Shalini / Jamal, Arham / Jeanes, Christopher / Kalra, Philip A / Kyriakidou, Christina / McAuley, Daniel F /

Meyrick, Agnieszka / Minassian, Angela M / Minton, Jane / Moore, Patrick / Munsoor, Imrozia / Nicholls, Helen / Osanlou, Orod / Packham, Jonathan / Pretswell, Carol H / San Francisco Ramos, Alberto / Saralaya, Dinesh / Sheridan, Ray P / Smith, Richard / Soiza, Roy L / Swift, Pauline A / Thomson, Emma C / Turner, Jeremy / Viljoen, Marianne E / Albert, Gary / Cho, Iksung / Dubovsky, Filip / Glenn, Greg / Rivers, Joy / Robertson, Andreana / Smith, Kathy / Toback, Seth

The New England journal of medicine

2021 Volume 385, Issue 13, Page(s) 1172–1183

Abstract: Background: Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype ... ...

Abstract	Background: Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population. Methods: In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline. Results: A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups. Conclusions: A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16.).
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines/administration & dosage ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/immunology ; Humans ; Immunogenicity, Vaccine ; Injections, Intramuscular/adverse effects ; Middle Aged ; SARS-CoV-2 ; Single-Blind Method ; Vaccines, Synthetic/immunology ; Young Adult
Chemical Substances	COVID-19 Vaccines ; Vaccines, Synthetic ; NVX-CoV2373 adjuvated lipid nanoparticle (2SCD8Q63PF)
Language	English
Publishing date	2021-06-30
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2107659
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Article ; Online: Bacterial sensitivity to chlorhexidine and povidone-iodine antiseptics over time: a systematic review and meta-analysis of human-derived data.

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Article ; Online: Diagnosing tuberculosis in the 21st century - Dawn of a genomics revolution?

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Article ; Online: The predictive role of symptoms in COVID-19 diagnostic models: A longitudinal insight.

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Article ; Online: Nanopore metagenomics enables rapid clinical diagnosis of bacterial lower respiratory infection.

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Article ; Online: Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial.

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Article ; Online: Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.

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