Journal of Infection and Chemotherapy最新文献

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Efficacy and safety of ceftazidime-avibactam in combination with metronidazole in Japanese patients with complicated intra-abdominal infection: A phase 3, multicentre, open-label study.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-20 DOI: 10.1016/j.jiac.2024.102598
Hiroshige Mikamo, Yoshiomi Nakazuru, Riko Tabuchi, Misaki Suzuki, Masahito Nagashima, Margaret Tawadrous, Michele Wible, Makoto Ohta
{"title":"Efficacy and safety of ceftazidime-avibactam in combination with metronidazole in Japanese patients with complicated intra-abdominal infection: A phase 3, multicentre, open-label study.","authors":"Hiroshige Mikamo, Yoshiomi Nakazuru, Riko Tabuchi, Misaki Suzuki, Masahito Nagashima, Margaret Tawadrous, Michele Wible, Makoto Ohta","doi":"10.1016/j.jiac.2024.102598","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.102598","url":null,"abstract":"<p><strong>Background: </strong>This phase 3 open-label study evaluated the efficacy and safety of ceftazidime-avibactam in Japanese patients with complicated intra-abdominal infections (cIAIs).</p><p><strong>Methods: </strong>Hospitalised adults with cIAI received ceftazidime-avibactam + metronidazole for 5-14 days. The primary efficacy endpoint was clinical cure at the test-of-cure (TOC) visit in the clinically evaluable (CE) analysis set. Efficacy was evaluated against a pre-defined point estimate criterion of ≥78%. Microbiological responses, safety and pharmacokinetics were assessed as secondary objectives.</p><p><strong>Results: </strong>Sixty patients were enrolled at 27 Japanese study sites; 59 (mean age 57 years, 42% female) were included in the modified intent-to-treat (MITT) analysis set. The most common baseline pathogens (microbiological MITT analysis set; n = 42) were Escherichia coli (n = 31; 74%), Pseudomonas aeruginosa (n = 6; 14%) and Klebsiella pneumoniae (n = 5; 12%); all were susceptible to ceftazidime-avibactam. In the CE analysis set (n = 40), 36 patients (90.0%; 95% confidence interval: 76.3, 97.2) achieved clinical cure at TOC. Favourable per-pathogen microbiological responses at TOC were >90% for common Gram-negative pathogens, including E. coli, K. pneumoniae, and P. aeruginosa. Adverse events were generally mild; the most common were constipation (12%), diarrhoea (12%), and insomnia (10%). Pharmacokinetic observations of ceftazidime and avibactam were consistent with previous reports.</p><p><strong>Conclusion: </strong>The proportion of patients with clinical cure at TOC was greater than the pre-defined threshold of 78.0%. These findings in Japanese patients are consistent with multi-regional phase 3 non-inferiority trials demonstrating the efficacy and safety of ceftazidime-avibactam in patients with cIAIs.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT04927312.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":"102598"},"PeriodicalIF":1.9,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
D-dimer is a strong predictor of mortality in paediatric hematological-oncological patients with severe infections.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-20 DOI: 10.1016/j.jiac.2024.12.022
Ming Jia, Shu-Peng Lin, Jing-Ying Zhang, Wei-Qun Xu, Chan Liao, Xiao-Jun Xu
{"title":"D-dimer is a strong predictor of mortality in paediatric hematological-oncological patients with severe infections.","authors":"Ming Jia, Shu-Peng Lin, Jing-Ying Zhang, Wei-Qun Xu, Chan Liao, Xiao-Jun Xu","doi":"10.1016/j.jiac.2024.12.022","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.022","url":null,"abstract":"<p><strong>Objectives: </strong>The purpose of this study was to explore the prognostic value of inflammatory biomarkers, including CRP, PCT, IL-6, IL-10,and the thrombotic biomarker D-dimer in predicting the development of severe infections and mortality in children with hematological malignancies.</p><p><strong>Methods: </strong>A retrospective observational study was performed from October 2018 to December 2020 at the Children's Hospital, Zhejiang University School of Medicine.It collected clinical data of pediatric patients diagnosed with hematological malignancies who experienced febrile illnesses. Blood samples were obtained within 24 hours of fever onset to test for D-dimer, Fibrinogen, PT, APTT, CRP, PCT and serum cytokine levels.</p><p><strong>Results: </strong>Analysis revealed that with escalating infection severity, biomarkers such as CRP, PCT, IL-6, IL-10 and D-dimer progressively increased. The D-dimer level showed the highest accuracy (AUC of 0.930) in predicting mortality among children with severe infections. The combined analysis of IL-6 and D-dimer significantly improves the accuracy of prognosis in sepsis cases. A 60-day survival rate was lower for patients with D-dimer levels above 1.91 mg/L.</p><p><strong>Conclusion: </strong>In conclusion, D-dimer levels have proven to be a reliable biomarker for predicting mortality in children with hematological malignancies experiencing severe infections.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Fulminant Edwardsiella tarda bacteremia following near-drowning episode in a patient without cirrhosis: A case report.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-19 DOI: 10.1016/j.jiac.2024.12.020
Minori Fujita, Hiroshi Ito, Jura Oshida, Daiki Kobayashi
{"title":"Fulminant Edwardsiella tarda bacteremia following near-drowning episode in a patient without cirrhosis: A case report.","authors":"Minori Fujita, Hiroshi Ito, Jura Oshida, Daiki Kobayashi","doi":"10.1016/j.jiac.2024.12.020","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.020","url":null,"abstract":"<p><p>Edwardsiella tarda is a Gram-negative intracellular pathogen within the Enterobacterales order, recognized as a causative agent of hemorrhagic septicemia in fish but also pathogenic to humans. However, the clinical course and prognostic factors of E. tarda bacteremia are not fully understood. We present a case of fulminant E. tarda bacteremia in a 90-year-old Japanese man without significant immunosuppression, developing after exposure to freshwater. The patient was admitted to the intensive care unit with septic shock following an accidental fall into an irrigation ditch. Despite appropriate empiric treatment, he passed away within 18 hours of admission. Blood cultures identified E. tarda, while Aeromonas hydrophila was detected in sputum. This case highlights the rapid progression and high mortality risk associated with E. tarda bacteremia; prolonged exposure to contaminated water and delayed transport to medical care were likely contributory factors to the fatal outcome. Furthermore, the detection of waterborne pathogens like A. hydrophila in respiratory samples may serve as a clue to consider possible water exposure in diagnostic reasoning.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Case of Cholangitis with Vibrio fluvialis Bacteremia Possibly Related to Frequent Consumption of Supermarket Sushi in a Japanese Woman with a Gallbladder-Duodenal Fistula.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-19 DOI: 10.1016/j.jiac.2024.12.023
Naoya Itoh, Nana Akazawa-Kai, Nobumasa Okumura, Ryo Sato
{"title":"A Case of Cholangitis with Vibrio fluvialis Bacteremia Possibly Related to Frequent Consumption of Supermarket Sushi in a Japanese Woman with a Gallbladder-Duodenal Fistula.","authors":"Naoya Itoh, Nana Akazawa-Kai, Nobumasa Okumura, Ryo Sato","doi":"10.1016/j.jiac.2024.12.023","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.023","url":null,"abstract":"<p><p>Vibrio fluvialis is a halophilic, motile, flagellated, gram-negative bacterium commonly associated with acute gastroenteritis. However, extraintestinal infections are rare. We describe an unusual case of V. fluvialis cholangitis complicated by bacteremia in a 78-year-old woman with diabetes mellitus and a gallbladder-duodenal fistula. The patient presented with fever and altered mental status, with a history of frequent sushi consumption. Blood cultures yielded V. fluvialis, identified through matrix-assisted laser desorption/ionization time-of-flight mass spectrometry with the MALDI Biotyper (Bruker Daltonics Co., Ltd., Yokohama, Japan) and biochemical properties. The patient was successfully treated with 7 days of intravenous ceftriaxone. There was no recurrence of fever for 6 days from the completion of antimicrobial treatment to discharge. This case underscores the need for heightened awareness of V. fluvialis as a potential pathogen in patients with predisposing conditions and dietary habits involving raw seafood. Further research is warranted to elucidate the mechanisms underlying its extraintestinal manifestations.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Flavonifractor plautii bacteremia following bacterial translocation from the gut: A case report and literature review.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-17 DOI: 10.1016/j.jiac.2024.12.021
Yukari Osada, Keisuke Oka, Mitsutaka Iguchi, Hiroshi Morioka, Ken-Ichi Iwata, Moeko Ohara, Nami Shimaoka, Tsunaki Sawada, Tetsuya Yagi
{"title":"Flavonifractor plautii bacteremia following bacterial translocation from the gut: A case report and literature review.","authors":"Yukari Osada, Keisuke Oka, Mitsutaka Iguchi, Hiroshi Morioka, Ken-Ichi Iwata, Moeko Ohara, Nami Shimaoka, Tsunaki Sawada, Tetsuya Yagi","doi":"10.1016/j.jiac.2024.12.021","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.021","url":null,"abstract":"<p><p>A 75-year-old male, hospitalized with back pain, remained hospitalized for tests for unexplained colitis, which was diagnosed as inflammatory bowel disease unclassified and treated with antibiotics and prednisolone, resulting in Clostridioides difficile colitis. Therefore, antibiotics were discontinued, and oral metronidazole treatment was initiated; however, as the patient's fever persisted, blood cultures were performed. An anaerobic bottle of blood culture turned positive the following day. Initial Gram staining of the positive blood culture fluid showed negative rods, and restaining detected small numbers of Gram-positive rods among the Gram-negative rods. The gray colonies on the subculture medium contained only Gram-negative rods. The bacterium was identified as Flavonifractor plautii using mass spectrometry. We ordered the ATCC 29863 F. plautii strain and compared with the strain of this case. The biochemical test result and the change in colony fluorescence under ultraviolet light of the strain isolated from the patient were identical to those of the ATCC strain, supporting the mass spectrometry results. Bacterial translocation from colonic mucosa was suspected, which improved following levofloxacin and metronidazole therapy. Only eight cases of human F. plautii infection have been reported, and we summarized them as a review. Careful and thorough isolation and identification of bacteria that are rarely isolated clinically, such as F. plautii, is crucial in accumulating evidence on rare infectious diseases.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142864430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Utility of direct microorganism species identification and antimicrobial susceptibility tests in urine samples.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-16 DOI: 10.1016/j.jiac.2024.12.019
Sachie Koyama, Noriyuki Watanabe, Haruki Naruse, Kotaro Mitsutake, Yasuhiro Ebihara
{"title":"Utility of direct microorganism species identification and antimicrobial susceptibility tests in urine samples.","authors":"Sachie Koyama, Noriyuki Watanabe, Haruki Naruse, Kotaro Mitsutake, Yasuhiro Ebihara","doi":"10.1016/j.jiac.2024.12.019","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.019","url":null,"abstract":"<p><strong>Introduction: </strong>Urinary tract infections (UTIs) are one of the most common bacterial infections and a major cause of sepsis. It is important to promptly diagnose and treat UTIs.</p><p><strong>Method: </strong>We found that a Gram-staining score of ≥2+ could be substituted for a colony-forming unit value of ≥10,000/mL. Using this criterion, we evaluated the performance of direct species identification (ID) and antimicrobial susceptibility testing (AST) using 233 isolates from urine.</p><p><strong>Results: </strong>Of the 212 monomicrobial isolates, 159 (75.0%) showed spectral scores of ≥1.7 using the direct ID. Of these, 135 isolates (135/159: 84.9%) were correctly identified at the species level (spectral score ≥2.0) and 153 isolates (153/159: 96.2%) were correctly identified at the genus level (spectral score ≥1.7), indicating that direct ID may be reliable for urine samples when the spectral score is ≥1.7. GNR were identified with higher accuracy compared with GPC. The ID results of 21 polymicrobial samples were not fully consistent with the conventional method. Of the direct AST results obtained from 146 isolates, there was 97.7% (1,501/1,537) categorical agreement (CA), 0.07% (1/1,537) very major errors, 0.7% (11/1,537) major errors, and 1.4% (22/1,537) minor errors, indicating high AST capability among the various isolates, including resistant strains. Twelve extended-spectrum beta-lactamase-producing bacteria were detected in 12 isolates, indicating high CA (99.2%) with direct AST.</p><p><strong>Conclusions: </strong>Direct ID and AST may be reliable for urine samples, but further improvements are required in order to realize accurate diagnosis and treatment, especially, for Gram-positive cocci and polymicrobial samples.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A case of fatal disseminated infection with masticator space abscess caused by ESBL-producing K57-ST412 hypervirulent Klebsiella pneumoniae.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-14 DOI: 10.1016/j.jiac.2024.12.013
Kohei Ukai, Yoshitaka Tomoda, Satoe Ishii, Satoshi Nakazato, Yohei Doi, Masahiro Suzuki, Sohei Harada
{"title":"A case of fatal disseminated infection with masticator space abscess caused by ESBL-producing K57-ST412 hypervirulent Klebsiella pneumoniae.","authors":"Kohei Ukai, Yoshitaka Tomoda, Satoe Ishii, Satoshi Nakazato, Yohei Doi, Masahiro Suzuki, Sohei Harada","doi":"10.1016/j.jiac.2024.12.013","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.013","url":null,"abstract":"<p><p>A 70-year-old Japanese man with well-controlled diabetes mellitus and chronic kidney disease was hospitalized for an examination of acute renal failure and elevated inflammatory reactions. He had a history of Klebsiella pneumoniae bacteremia without extended-spectrum β-lactamase (ESBL) production five months earlier. The patient was found to have bacteremia due to hypermucoviscous ESBL-producing Klebsiella pneumoniae, and developed septic shock, multiple cerebral infarctions, and an abscess in the left masticatory muscle space. The causative organism was resistant to ampicillin-sulbactam and piperacillin-tazobactam, which were used for empiric therapy, and the patient died despite subsequent definitive treatment with meropenem. Whole genome sequencing analysis showed that the strain of K. pneumoniae was ST412 with capsular genotype K57 and carried virulence genes iroBCDN, iucABCD, iutA, mrkABCDFHIJ, rmpA2, ybtAEPQSTUX. The strain also carried the bla<sub>CTX-M-15</sub> ESBL gene. Although the antimicrobial susceptibility of the causative organisms of hvKp infections in Japan has been favorable in most cases, severe infections caused by ESBL-producing hvKp may increase in the near future considering the recent increase in ESBL-producing K. pneumoniae.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142837169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical value of serum miRNA-206 in pulmonary tuberculosis.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-13 DOI: 10.1016/j.jiac.2024.12.018
Wei Chu, Hongqiu Pan, Zhongting Fei, Tiantian Zhang
{"title":"Clinical value of serum miRNA-206 in pulmonary tuberculosis.","authors":"Wei Chu, Hongqiu Pan, Zhongting Fei, Tiantian Zhang","doi":"10.1016/j.jiac.2024.12.018","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.018","url":null,"abstract":"<p><strong>Objective: </strong>This study sought to investigate the diagnostic value and the effect of microRNA (miR)-206 on drug resistance in pulmonary tuberculosis (TB) patients.</p><p><strong>Methods: </strong>This study included 88 TB patients (TB group) as study subjects, 80 healthy subjects as control 1 (Control group), and 85 latent TB infection (LTBI) patients as control 2 (LTBI group). The drug resistance of TB patients after standard anti-TB treatment was recorded. TB patients were assigned into the pan-sensitive and drug-resistance groups, with miR-206 level in drug-resistant TB patients analyzed. The correlation coefficients between inflammatory indicators (TNF-α, IgG, IL-4, IFN-γ, IP-10) and drug resistance in TB patients were analyzed, and the independent correlation between miR-206 levels and drug resistance was analyzed.</p><p><strong>Results: </strong>Compared to the Control and LTBI groups, serum miR-206 and IP-10 were highly-expressed in TB group. The miR-206 levels positively correlated with IP-10 levels. miR-206 had potential diagnostic value for TB. Levels of TNF-α, IgG, IFN-γ, and IL-4 were elevated in TB group and positively-correlated with miR-206 levels. Moreover, miR-206 levels were higher in the Drug-resistance group than the pan-sensitive group. The low-expression group had a lower incidence of drug resistance than the high-expression group (χ<sup>2</sup> = 16.84, P < 0.0001). miR-206 was the most significant indicator affecting drug resistance in TB patients (β = 0.516, P = 0.013). miR-206 was an independent risk factor for drug resistance.</p><p><strong>Conclusion: </strong>High miR-206 expression helps TB diagnosis and may predict drug-resistance incidence. miR-206 may be an independent risk factor for drug resistance in TB patients.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risks and Prevention of Severe Respiratory Syncytial Virus Infection among Infants and Children with Pulmonary Hypoplasia, Airway Stenosis, Congenital Esophageal Atresia, Inborn Errors of Metabolism, or Neuromuscular Diseases in Japan.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-12 DOI: 10.1016/j.jiac.2024.12.017
Masaaki Mori, Yoshinori Ito, Naruhiko Ishiwada, Kenta Ito, Masayoshi Shinjoh, Takeshi Tsugawa, Takanori Funaki, Munehiro Furuichi, Tadashi Hoshino, Isao Miyairi, Takuya Kondo, Akinari Hinoki, Motoshi Wada, Kuniyuki Okada, Seigo Korematsu, Naoyuki Tanuma, Hisaya Hasegawa, Kenichiro Hosoi, Kanako Yoshizaki, Mika Ishige
{"title":"Risks and Prevention of Severe Respiratory Syncytial Virus Infection among Infants and Children with Pulmonary Hypoplasia, Airway Stenosis, Congenital Esophageal Atresia, Inborn Errors of Metabolism, or Neuromuscular Diseases in Japan.","authors":"Masaaki Mori, Yoshinori Ito, Naruhiko Ishiwada, Kenta Ito, Masayoshi Shinjoh, Takeshi Tsugawa, Takanori Funaki, Munehiro Furuichi, Tadashi Hoshino, Isao Miyairi, Takuya Kondo, Akinari Hinoki, Motoshi Wada, Kuniyuki Okada, Seigo Korematsu, Naoyuki Tanuma, Hisaya Hasegawa, Kenichiro Hosoi, Kanako Yoshizaki, Mika Ishige","doi":"10.1016/j.jiac.2024.12.017","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.017","url":null,"abstract":"<p><strong>Background: </strong>In March 2024, children with pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, inborn errors of metabolism, and neuromuscular diseases became eligible for palivizumab in Japan. Despite limited epidemiological data, expert consensus guided the recommendation for palivizumab use in these children to ensure its proper application.</p><p><strong>Objectives: </strong>This article outlines the proper use of palivizumab for RSV infection in infants and children with the specified conditions, aiming to enhance understanding of the medical basis for its clinical guidance.</p><p><strong>Methods: </strong>A nationwide survey targeted pediatric specialist facilities. Additionally, an investigator-initiated clinical trial under AMED evaluated palivizumab's efficacy and safety in newborns, infants, and young children with the five high-risk diseases.</p><p><strong>Results: </strong>Palivizumab was given to 23 children aged 24 months or younger with the specified conditions. No RSV-related hospitalizations occurred, and serum concentrations remained therapeutically effective. Adverse events were consistent with existing data, with no serious events linked to palivizumab.</p><p><strong>Conclusion: </strong>Following successful trial results, early approval was granted on March 26, 2024. This article aims to promote the appropriate use of palivizumab for RSV infection in children with the specified conditions through clinical guidance.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Building vancomycin population pharmacokinetic model for Japanese low birth weight infants in comparing it with previously reported pediatric population pharmacokinetic models.
IF 1.9 4区 医学
Journal of Infection and Chemotherapy Pub Date : 2024-12-11 DOI: 10.1016/j.jiac.2024.12.009
K O J I Masuda, K E N J I Ikeda, A I J U Endo, T A K A H I R O Ishikawa, T E T S U Y A Matsumoto
{"title":"Building vancomycin population pharmacokinetic model for Japanese low birth weight infants in comparing it with previously reported pediatric population pharmacokinetic models.","authors":"K O J I Masuda, K E N J I Ikeda, A I J U Endo, T A K A H I R O Ishikawa, T E T S U Y A Matsumoto","doi":"10.1016/j.jiac.2024.12.009","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.12.009","url":null,"abstract":"<p><strong>Background and objectives: </strong>Vancomycin (VAN) is one of therapeutic agents for severe infections, and its efficacy and safety are subject to therapeutic drug monitoring. However, there is a lack of data regarding the administration of VAN to low birth weight (LBW) infants. This presents a challenge to ensure optimal dosing and maximize the benefits of VAN therapy in this specialized patients.</p><p><strong>Materials and methods: </strong>VAN serum samples were collected through opportunistic sampling for clinical use. Population Pharmacokinetics (PopPK) analysis was conducted with a one-compartment model in a nonlinear mixed-effects model using Phoenix NLME (Certara ver.8.4). We compared the final model with the 12 previously reported PopPK models.</p><p><strong>Results: </strong>A total of 106 samples from 25 patients were obtained to establish the PopPK model for LBW infants. We successfully developed one-compartment PopPK model using Phoenix NLME based on Japanese LBW infants receiving VAN with body weights of less than 2,500 g. The covariates in our PopPK model are postmenstrual age, body weight, and serum creatinine for clearance and postnatal age for volume of distribution. A comparison of the goodness-of-fit metrics indicated that our PopPK model achieved better prediction accuracy for VAN blood concentrations, as indicated by the lower values of these metrics.</p><p><strong>Conclusion: </strong>We successfully established a PopPK model incorporating PNA and PMA as new covariates. By addressing the issue of data scarcity in LBW infants, our study provides insights and strategies to manage VAN therapy in LBW infants, thus optimizing its effectiveness and safety.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142822105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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