Shria Kumar, MD, from the University of Miami, and colleagues evaluated the results of community-based HP testing in an at-risk, underserved population. The analysis included 155 participants undergoing testing using a portable urea breath test machine.

The researchers found that 34% of participants had HP infection, 63% were negative, and 3% were indeterminate. HP infection was significantly more common among participants who were Hispanic/Latino (79 vs 54%), younger (48 vs 52 years), and non-English speakers (Spanish-speaking: 67 vs 30%). Among the 52 participants with infection, 42% were retested with confirmed eradication, 37% were unable to be recontacted, and 19% did not complete treatment. Barriers identified by participants included medication tolerability, frequent dosing, and logistics of attending a second testing session. High motivation for testing and treatment was seen among those with familiarity of the association between HP and gastric cancer.

“While our medication-focused eradication rate is 96%, suggesting acceptable rates of eradication based on antibiotic efficacy, an intention-to-treat analysis yields markedly lower results: among 52 with infection, only 42% had confirmed eradication,” the authors write.

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In a retrospective cohort study at 619 US hospitals, Jeffrey R. Strich, MD, from the National Institutes of Health in Bethesda, Maryland, and colleagues examined use patterns of recently US Food and Drug Administration-approved gram-negative antibiotics and identified factors associated with their preferential use over traditional generic agents in patients with gram-negative infections due to pathogens displaying difficult-to-treat resistance (DTR).

The researchers found that ceftolozane–tazobactam (approved in 2014) and ceftazidime–avibactam (approved in 2015) predominated new antibiotic usage between quarter 1 of 2016 and quarter 2 of 2021, while there was relatively low uptake of subsequently approved gram-negative antibiotics. Overall, 0.7% of the gram-negative infection hospitalizations displayed DTR pathogens. In 41.5% of DTR episodes, patients were treated exclusively using traditional agents, including reserve antibiotics such as polymyxins, aminoglycosides, and tigecycline in 79.3%. The adjusted probability of receiving newer versus traditional antibiotics for DTR infections was greater for patients with bacteremia and chronic diseases and was lower for those with do-not-resuscitate status, acute liver failure, and Acinetobacter baumannii complex and other nonpseudomonal nonfermenter pathogens.

“There is a stark imbalance between available new antibiotics and unmet pathogen targets,” the authors write. “These findings call for paradigm-changing countermeasures.”

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Trisha N. Peel, MB, BS, PhD, from Monash University in Melbourne, Australia, and colleagues conducted a multicenter, superiority, placebo-controlled trial in which adult patients without known methicillin-resistant Staphylococcus aureus (MRSA) colonization who were undergoing arthroplasty were randomly assigned to receive 1.5g vancomycin or normal saline placebo in addition to cefazolin prophylaxis. The modified intention-to-treat analysis included 4113 patients: 2233 undergoing knee arthroplasty; 1850 undergoing hip arthroplasty; and 30 undergoing shoulder arthroplasty.

The researchers found that surgical site infections occurred in 4.5 and 3.5% of patients in the vancomycin and placebo groups, respectively, among the modified intention-to-treat population (relative risk, 1.28; 95% CI, 0.94 to 1.73; P =.11). Surgical site infection occurred in 5.7 and 3.7% of patients in the vancomycin and placebo groups, respectively, among those undergoing knee arthroplasty (relative risk, 1.52; 95% CI, 1.04 to 2.23). For those undergoing hip arthroplasty, the corresponding proportions were 3.0 and 3.1% (relative risk, 0.98; 95% CI, 0.59 to 1.63). Adverse events occurred in 1.7% of patients in both the vancomycin group and the placebo group.

“In this pragmatic, randomized trial involving adult patients undergoing arthroplasty who had a low prevalence of MRSA colonization, the addition of vancomycin was not superior to surgical antimicrobial prophylaxis with cefazolin,” the authors write.

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On behalf of the AGA, Anne F. Peery, MD, from the University of North Carolina at Chapel Hill, and colleagues developed guidelines to provide recommendations on use of fecal microbiota-based therapies in adults with recurrent C. difficile infection, severe to fulminant C. difficile infection, inflammatory bowel diseases, including pouchitis, and irritable bowel syndrome. The Evidence-to-Decision framework was used to develop recommendations and provide considerations for implementation in clinical practice.

The guideline panel developed 7 recommendations. The AGA suggests select use of fecal microbiota-based therapies upon completion of standard-of-care antibiotics to prevent recurrence among immunocompetent adults with recurrent C. difficile. Use of conventional fecal microbiota transplant is suggested in mildly or moderately immunocompromised adults with recurrent C. difficile infection. The AGA suggests against use of any fecal microbiota-based therapies to prevent recurrent C. difficile in severely immunocompromised adults. Select use of conventional fecal microbiota transplant is suggested for adults hospitalized with severe or fulminant C. difficile not responding to standard-of-care antibiotics. Except in the context of clinical trials, the AGA suggests against use of conventional microbiota transplant as treatment for inflammatory bowel diseases or irritable bowel syndrome.

“Fecal microbiota transplant is a safe and effective treatment with enough scientific evidence to be offered to most patients with two or more C. diff recurrences,” Peery said in a statement.

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The Food and Drug Administration (FDA) has approved Cyfendus (anthrax vaccine absorbed, adjuvanted) for postexposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.

Cyfendus is made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of B. anthracis. The vaccine is administered intramuscularly as a series of 2 doses (0.5mL each) two weeks apart postexposure in combination with antibacterial therapy. 

The approval was supported by data from a series of studies including a multicenter, randomized, double-blind, parallel-group phase 3 study (ClinicalTrials.gov Identifier: NCT03877926) that evaluated the lot consistency, immunogenicity, and safety of Cyfendus compared with BioThrax in adults aged 18 to 65 years.

Findings showed that 66.3% participants who received Cyfendus achieved a vaccine-induced TNA 50% neutralization factor (NF₅₀) response value ≥0.56 at day 64 (coprimary endpoint). Cyfendus was also found to be noninferior to BioThrax based on the percent difference between participants achieving a threshold TNA NF₅₀ value ≥0.29 at day 64 (coprimary endpoint).

In a phase 2 study (ClinicalTrials.gov Identifier: NCT04067011), the concomitant administration of Cyfendus with oral ciprofloxacin or doxycycline was found not to have a clinically relevant impact on the pharmacokinetics of either antibiotic or on the immunogenicity of Cyfendus. The study was conducted in males and females aged 18 to 45 years.

The most common injection-site reactions reported with Cyfendus were tenderness (88.1%), pain (86.3%), arm motion limitation (63.7%), warmth (51.2%), induration (37.5%), itching (21.9%), swelling (19.7%), and erythema/redness (17.9%). The most common systemic adverse reactions were muscle aches (75.2%), tiredness (67.1%) and headache (58.0%). 

“Cyfendus vaccine is a component of the US government’s preparedness efforts against anthrax, which remains a high-priority national security threat due to its ability to be easily disseminated, lethality, and potential for major public health impact,” said Paul Williams, Emergent’s senior vice president, products business. “The approval of the Cyfendus vaccine demonstrates what effective public-private partnerships can achieve for national security. Emergent will continue to work closely with the US government to transition this product to post-approval procurement while ensuring an uninterrupted supply of this important vaccine.”

Cyfendus is supplied in multiple-dose vials containing ten 0.5mL doses.

Noting that interleukin-12 shares a common subunit with interleukin-23, Aristine Cheng, MD, from the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, and colleagues screened patients (most of whom had thymoma) who were known to have anti-interleukin-12 for autoantibodies against interleukin-23. In addition, a second cohort of patients with thymoma and those without thymoma or known anti-interleukin-12 with unusual infections was tested.

The researchers found that 50% of the 30 patients with anti-interleukin-12 who had severe mycobacterial, bacterial, or fungal infections had antibodies that neutralized interleukin-23. There was a correlation noted between the potency of such neutralization and the severity of these infections. There was no association seen for the neutralizing activity of anti-interleukin-12 alone with infection. The presence of anti-interleukin-23 was associated with infection status in 81% of the validation cohort of 91 patients with thymoma. Overall, neutralizing anti-interleukin-23 was detected in 26% of the patients with thymoma and 83% with disseminated, cerebral, or pulmonary infections. In 19 and 12% of patients with severe intracellular infections and unusual intracranial infections, respectively, anti-interleukin-23 was present.

“The study of Cheng et al provides support that anti-interleukin-23 autoantibodies contribute to adult-onset immunodeficiency,” Mihai G. Netea, MD, PhD, and Frank L. van de Veerdonk, MD, PhD, from the Radboud University Medical Center in Nijmegen, Netherlands, write in an accompanying editorial. “At the clinical level, this study should lead to the design of new diagnostic tests and therapeutic approaches based on anti-interleukin-23 autoantibodies in patients with rare and severe infections of unknown cause.”

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HealthDay News — In children with acute sinusitis, antibiotic treatment had minimal benefit for those without nasopharyngeal bacterial pathogens, according to a study published in the July 25 issue of the Journal of the American Medical Association.

Nader Shaikh, MD, MPH, from the University of Pittsburgh, and colleagues conducted a clinical trial in which 515 children (aged 2 to 11 years) diagnosed with acute sinusitis based on clinical criteria were randomly assigned to oral amoxicillin (90mg/kg/day) and clavulanate (6.4mg/kg/day; 254 patients) or placebo (256 patients) for 10 days. Daily symptom burden was compared between the groups to see if there were differences by nasopharyngeal colonization with bacterial pathogen or color of the nasal discharge.

The researchers found that the mean symptom scores were significantly lower in children in the amoxicillin and clavulanate group (9.04 vs 10.60 in the placebo group) and the length of time to symptom resolution was significantly lower for children in the antibiotic group (7.0 vs 9.0 days). The benefit from antibiotic treatment was greater in children with nasopharyngeal pathogens detected vs those with pathogens detected (between-group difference in mean symptom scores, −1.95 vs −0.88). Efficacy did not differ significantly based on whether colored nasal discharge was present vs not present (the between-group difference was −1.62 vs −1.70).

“Testing for specific bacteria on presentation may represent a strategy to reduce antibiotic use in this condition,” the authors write.

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HealthDay News — Antimicrobial stewardship programs (ASPs) reduce antibiotic prescriptions and consumption of antibiotics, according to a review and meta-analysis published online February 9 in JAMA Network Open.

Kyaw Zay Ya, MB, BS, MPH, from the Swiss Tropical and Public Health Institute in Allschwil, and colleagues conducted a systematic review and meta-analysis to examine the association between ASPs and consumption of antibiotics globally. A total of 52 studies with 1,794,889 participants were included: 40 and 12 were conducted in high-income countries and low- and middle-income countries, respectively.

The researchers found that ASPs were associated with a reduction of 10% in antibiotic prescriptions and a 28% decrease in consumption of antibiotics (rate ratio, 0.72). In pediatric hospitals, there was a 21% reduction in antibiotic consumption noted in association with ASPs. Furthermore, a 28% reduction was seen in World Health Organization Watch group antibiotics in association with ASPs (rate ratio, 0.72).

“ASPs were also associated with reduced consumption of antibiotics on the WHO Watch list, with particularly high risk of selection of bacterial resistance,” the authors write. “In light of concerning increased use of Watch antibiotics globally, this is good news, as it suggests that protecting these drugs through appropriate ASPs is possible.”

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