Latest news with #antibioticresistance
Mail & Guardian
3 days ago
- General
- Mail & Guardian
Antibiotic resistance profiles of oral flora in hippopotami (Hippopotamus amphibius): implications for treatment of human bite wound infections
Name of research institution: University of Pretoria Name of Faculty: Veterinary Science Name of department: Veterinary Tropical Diseases First author of the paper: Professor Anita Michel Authors: Maralize Engelbrecht, Francois Roux2 Jeanette Wentzel and Annelize Jonker Email address: Name of submitter: Professor Karen Keddy Capacity of submitter: Head of Department: Veterinary Tropical Diseases Email address of submitter: Submitting authority: Faculty of Veterinary Science Short description of the research: The common hippopotamus ( Hippopotamus amphibius ) which occurs in rivers, lakes and wetlands in sub-Saharan Africa, is known for its aggressive behaviour when defending its territory. This leads to numerous attacks on people close to water often leading to life-threatening injuries and severe wound infections. Our study investigated the bacterial spectrum common to the oral cavity of the hippopotamus and the antibiotic susceptibility profiles of those bacteria as this is of crucial importance to the effective treatment of bite wound infections caused by hippopotami. The findings showed that the bacteria usually residing in the hippopotamus' mouth are aquatic bacteria with a high level of antibiotic resistance to several antibiotic drugs which are commonly used to treat bite wound patients. This study highlights the need for revised, more effective treatment protocols that take into consideration the antibiotic susceptibility profiles reported in this paper. For the full paper see below:
Associated Press
19-05-2025
- Health
- Associated Press
Armata Pharmaceuticals Announces Positive Topline Data from the Phase 1b/2a diSArm Study of Intravenously Administered AP-SA02 in Complicated Staphylococcus aureus Bacteremia
All primary endpoints for safety, tolerability, and clinical response in the intent-to-treat population met AP-SA02 arm significantly improved clinical outcomes and prevented relapse compared to best available antibiotic therapy No treatment-related serious adverse events were observed with repetitive intravenous dosing LOS ANGELES, May 19, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ('Armata' or the 'Company'), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced positive topline results from its Phase 1b/2a diSArm trial which evaluated AP-SA02, a novel intravenous ('IV') administered multi-phage therapeutic for the treatment of Staphylococcus aureus ('S. aureus') bacteremia ('SAB'), in the intent-to-treat ('ITT') population. 'This trial and these data are what the field of phage therapy has been eagerly awaiting for over a decade and represent a critical leap forward for Armata and for the role of bacteriophages in combating life-threatening systemic infections,' stated Dr. Deborah Birx, Chief Executive Officer of Armata. The diSArm study ( NCT05184764 ) was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy ('BAT') compared to BAT alone (placebo) for the treatment of adults with complicated SAB. Safety and efficacy were assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo. AP-SA02, administered IV every six hours for five days, was well-tolerated, with no serious adverse events related to the study drug. Two subjects had adverse events that were possibly related to the study drug: one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation of vancomycin. The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at (i) Test of Cure ('TOC') for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined as one week following the end of IV BAT, and (iii) end of study ('EOS'), defined as four weeks following the end of IV BAT. A statistically significant increase in investigator-assessed responder rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%) versus placebo (58%) (p = 0.047). At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded (p = 0.017) versus 25% of placebo subjects considered non-responsive due to either relapse or treatment failure, consistent with the non-responder rate reported in the literature for recent phase 3 trials. Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with methicillin-sensitive S. aureus ('MSSA') or methicillin-resistant S. aureus ('MRSA'). All subjects infected with MRSA and treated with AP-SA02 and BAT cleared their infection by TOC for BAT with no evidence of relapse through EOS, as compared to the relapse rate of BAT alone as noted above. Supporting the investigator assessment, clinical outcome was assessed by the Clinical Efficacy Adjudication Committee, comprised of leading doctors in the bacteremia field, who agreed that subjects who received placebo had a 22% and 25% non-responder rate at TOC with BAT and at EOS, respectively, while 100% of the subjects who received AP-SA02 clinically responded (p = 0.025: TOC BAT; p = 0.020: EOS). Additionally, faster time to a negative blood culture and decline of key predictors of mortality and complications in SAB, including interleukin-10 and C-reactive protein, support the improved responder rates in subjects treated with AP-SA02. 'This clinical trial is groundbreaking in two fundamental ways: firstly, this is the first clear evidence in a randomized controlled trial of the efficacy of phage against a serious systemic pathogen that is responsible for significant morbidity and mortality in the United States, and secondly, Armata was able to successfully produce high titer phage with high purity allowing for repetitive IV administration every six hours without significant safety concerns,' continued Dr. Birx. 'We previously demonstrated the persistence of AP-SA02 in the IV space on multiple days one hour post IV push. Critically, these trial results support AP-SA02 homing to different sites of infection, presumably penetrating biofilms, and infecting and lysing the target S. aureus bacteria, independent of antibiotic resistance patterns and site of infection.' 'These data, including the favorable safety profile of AP-SA02, warrant that we move as rapidly as possible towards initiation of a pivotal trial. I am grateful to the patients who participated in this study, our excellent trial sites, and the unrelenting commitment of the Armata team. Finally, this progress and this initial breakthrough would not have been possible without ongoing support from Innoviva and the U.S. Department of Defense.' 'Importantly, Armata has developed the capacity to manufacture drug product at its cGMP facility in California. All Active Pharmaceutical Ingredients are maintained in house and Armata's current proprietary manufacturing process can produce over 10,000 full courses of phage therapy annually, distributed from its facility, consistent with supporting the need to onshore biomedical breakthroughs needed by the American people,' Dr. Birx concluded. Armata's latest corporate presentation with topline results from the Phase 1b/2a diSArm study can be found here. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage-specific current Good Manufacturing Practices ('cGMP') manufacturing to support full commercialization. Forward Looking Statements This communication contains 'forward-looking' statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant cGMP; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption 'Risk Factors' and elsewhere in Armata's filings and reports with the U.S. Securities and Exchange Commission (the 'SEC'), including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2025, and in its subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Media Contacts: At Armata: Pierre Kyme [email protected] 310-665-2928 Investor Relations: Joyce Allaire LifeSci Advisors, LLC [email protected] 212-915-2569 View original content to download multimedia: SOURCE Armata Pharmaceuticals, Inc.
The Independent
14-05-2025
- Health
- The Independent
Companies that provide surgery abroad should foot NHS bill, nurses say
Nurses have warned that surgical procedures abroad are too easily being sold as 'holiday packages', as they called for companies providing the operations to foot the NHS bill when things go wrong. So-called surgical tourism could also be driving a deadly resistance to antibiotics. The trend of people travelling overseas for the likes of weight loss surgery, dental care and cosmetic procedures is 'likely to grow', nurses said, despite some patients dying from complications. Speaking to delegates at the Royal College of Nursing's annual congress in Liverpool, Nicola Smith, who works in district nursing, said she has been 'really shocked' by some cases. 'Over the last two years, I've seen some horrendous, horrendous wounds coming back from people that have had surgery abroad,' she said. She spoke of one woman whose wound from skin removal surgery – which is usually performed after weight loss – turned necrotic. Ms Smith added: 'I think she thought she would come home, have a quick recovery and go back to work. I ended up sending her in with sepsis. 'It's really sad – this procedure was sold to her as like a holiday package. 'A lot of young people are very exposed to social media. You know, 'you can have a holiday, six grand'. 'All she told me about was how fantastic the hotel was after she had her surgery. There was no blood pressure tested. There was no aftercare for this woman at all. 'In fact, to be fair, I'm surprised she made it back on the flight. It's really scary. 'We need to educate our young people … we need to educate people on the dangers of having surgery abroad.' Infection control nurse Nykoma Hamilton, of the RCN Fife branch, suggested companies that provide packages which include hotels, surgery and transfers to appointments should pay insurance for the NHS to seek financial compensation when complications arise. 'We're all getting told to tighten our budget,' Ms Hamilton told delegates. 'So if people have decided that the wait list is too long, they're in too much pain, for whatever reason, they've decided to have that option of surgery abroad, that company that they went with, they should pay an insurance, so if you do have to be cared for by the NHS for – and we've seen some horrid complications – the NHS should then be able to seek financial compensation from that company.' She also issued a warning over the 'granddaddy' of antibiotic resistance. 'Our concerns relate to the fact that a lot of people are colonised with a lot of extensively drug resistant organisms,' Ms Hamilton said. 'Now, that is a global health problem that affects us here in the UK, as well as abroad, but the infection control teams are getting slightly worried. 'So we've had a near 30% increase in the detection of carbapenemase resistance – now that's your absolute granddaddy of resistance ones.' Carbapenems are among the most powerful antibiotics, while carbapenemases are chemicals made by some strains of bacteria. These chemicals allow the bacteria to destroy carbapenems and become resistant to the antibiotic. Ms Hamilton said patients can be colonised with this bacteria and live with it for a while without harm, unless it gets into the bloodstream when they will be resistant to most of the antibiotics available. Elsewhere, Samantha Spence, who tabled the debate at the RCN congress, claimed about 5,000 people from the UK travelled abroad for weight loss surgery alone last year. 'That was almost equal to the number treated within the NHS in 2021/22,' she added. 'Now within the UK, private care is costly. NHS waiting lists long. This trend looks likely to grow. 'While some return with positive life-changing outcomes, others come back with complications requiring urgent care, adding strains to NHS resources. 'With variations in infection control, differing medical standards, lack of follow up, coordination, tragically, some patients have died from such complications.'
