VE303,一个定义的细菌联盟,用于预防复发的Clostridioides difficile感染:随机临床试验
Thomas Louie1, Yoav Golan2, Sahil Khanna3
1University of Calgary and Foothills Medical Centre, Calgary, Alberta, Canada.
JAMA
|April 15, 2023
概括
与安慰剂相比,高剂量VE303,一种已定义的开始性Clostridia,显著降低了高风险成年人的复发性Clostridioides difficile感染 (CDI). 需要进一步的第三阶段试验来证实这些有前途的CDI预防结果.
科学领域:
- 微生物学
- 胃肠病学
- 临床试验
背景情况:
- 困难杆菌感染 (CDI) 具有显著的复发风险,特别是在高风险的成年人群中.
- 开始性Clostridia在预防CDI复发中的作用在很大程度上是未知的.
- VE303是一种合理定义的细菌联盟,包括8种非致病性,非毒性Clostridia菌株.
研究的目的:
- 评估VE303在高风险成年人中预防复发性CDI的疗效.
- 为未来的第三阶段临床试验确定最佳的VE303剂量.
主要方法:
- 进行了一项2期随机双盲,安慰剂控制,剂量调整的研究.
- 79名已确诊的CDI和高复发风险的参与者被随机分配给高剂量VE303,低剂量VE303或安慰剂14天.
- 主要终点是使用临床和实验室标准评估的8周后CDI复发.
主要成果:
- 与安慰剂相比,高剂量VE303在8周内显著减少了CDI复发率 (13. 8%与45. 5%,P=. 006).
- 与安慰剂相比,低剂量VE303也显示出复发率下降的趋势,但没有达到统计学意义 (37. 0%).
- 所有治疗组的基线特征都相似.
结论:
- 高剂量的VE303在高危成年人中有效预防复发性CDI.
- 这些发现支持在更大的第三阶段研究中对VE303进行进一步的研究.
- VE303代表了预防CDI的潜在新疗法.
相关概念视频
Drugs for Treatment of Diarrhea-Predominant IBS
236
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
236
Antimicrobial Effectiveness
99
The effectiveness of antimicrobial agents depends on various factors influencing their ability to eliminate microbial populations. Larger microbial populations require more time for complete eradication, emphasizing the importance of population size analysis when evaluating antimicrobial efficacy.Microbial resistance to antimicrobial agents varies significantly. Highly resilient microorganisms include endospores, gram-negative bacteria, and non-enveloped viruses, while prions are exceptionally...
99
Healthcare Associated Infections II: Preventive Measures
2.7K
Essential infection prevention measures are based on the knowledge of the infection chain, the modes of transmission in healthcare settings, and the use of the best practices in all healthcare settings. Compulsory public reporting of healthcare-associated infection rates is needed to allow individuals and the community to make informed choices regarding selecting a healthcare facility.
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...
2.7K
Urinary Tract Infection III: Diagnostic Studies and Interprofessional Care
17
A healthcare provider can diagnose a urinary tract infection (UTI) through several methods:Medical History and Symptoms: The provider will take a detailed medical history and ask about symptoms such as frequent urination, burning sensation during urination, and lower abdominal pain.Urinalysis: A clean-catch urine sample is collected in a sterile container and tested for the presence of bacteria, white blood cells (leukocytes), nitrites, blood, and protein. The presence of leukocytes and...
17
Drugs for Treatment of Ulcerative Colitis in IBD
186
Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide...
186
Bacterial Flora of the Large Intestine
545
The gut microbiome is formed by a vast and diverse community of bacteria that colonizes our large intestine. These bacteria start residing in the gut from birth and continue diversifying throughout life, influenced by factors such as diet, lifestyle, and stress. The gut bacterial community also includes bacteria from food and those that enter the colon through the anus.
The normal gut flora of the colon plays a critical role in generating essential vitamins such as vitamins K, B5, and B7.
The normal gut flora of the colon plays a critical role in generating essential vitamins such as vitamins K, B5, and B7.
545


