Spangler Frank L, Williams Cheau, Aberger Michael E, Wilson Bradley A, Ajib Khaled, Gholami Shahram S, Goodwin Henry N, Park Lauren Y, Kardjadj Moustafa, Derrick DeAndre, Huard Thomas K
Soft Cell Laboratories, Saint George, UT, USA.
Colquitt Regional Medical Center, Moultrie, Georgia.
Diagn Microbiol Infect Dis. 2025 Mar;111(3):116646. doi: 10.1016/j.diagmicrobio.2024.116646. Epub 2024 Dec 7.
Complicated urinary tract infections (cUTIs) are difficult to manage due to their polymicrobial nature and resistance to standard therapies. In current clinical practice, the management of a cUTI often starts with broad-spectrum antimicrobials until culture and sensitivity (C&S) results are available, but these diagnostic delays further hinder treatment efficacy. Polymerase Chain Reaction (PCR) offers a faster alternative. This study evaluates PCR's utility compared to C&S, focusing on agreeability, discordant results, clinical outcomes, and antimicrobial selection efficacy to improve cUTI management.
The clinical study was conducted in two parts: the primary study focused on patients with cUTIs, while the sub-study involved healthy individuals without signs or symptoms of urinary tract infection (UTI). All collected samples underwent analysis using both PCR and C&S for comparison. Building on the first part of the study, the research evaluated outcome measures related to discordant analysis.
Overall, our study supports good agreement between PCR and C&S in positive cases (95.32 % at baseline and 88.06 % at end of study (EOS)) but reveals some discordance in negative cases (38.30 % at baseline and 62.91 % at EOS). The negative percent agreement (NPA) in the sub-study on the healthy population was 70.16 %. Further analysis of discordant results revealed that symptomatic patients treated for PCR-positive infections trended toward better clinical outcomes (77.45 % vs. 71.42 %) and higher rates of microbiological eradication (53.92 % vs. 50 %) compared to those treated for C&S-positive infections. Additional analysis on antimicrobial use and microbiological aspects revealed that the PCR group received more oral medication-based treatments, while the C&S group received other forms (intramuscular or bladder irrigation). In cases of discordant results, there were more PCR-positive but culture-negative cases than PCR-negative but culture-positive cases.
Our clinical utility study data suggests that PCR-guided management of cUTIs is overall superior to conventional C&S, offering several advantages. PCR has the potential to enhance patient care by enabling the early adoption of narrower antibiotic therapies, improving clinical outcomes, and ensuring the effective selection of antimicrobials. A PCR-guided management plan could be particularly beneficial in managing patients with cUTIs, addressing infections that are occasionally overlooked with current C&S-guided treatment protocols.
复杂性尿路感染(cUTIs)因其微生物种类多样且对标准疗法耐药,难以进行管理。在当前临床实践中,cUTI的管理通常始于使用广谱抗菌药物,直至获得培养和药敏(C&S)结果,但这些诊断延迟进一步阻碍了治疗效果。聚合酶链反应(PCR)提供了一种更快的替代方法。本研究评估了PCR与C&S相比的效用,重点关注一致性、不一致结果、临床结局以及抗菌药物选择效果,以改善cUTI的管理。
临床研究分两部分进行:主要研究聚焦于cUTI患者,而子研究涉及无尿路感染(UTI)体征或症状的健康个体。所有收集的样本均采用PCR和C&S进行分析以作比较。在研究的第一部分基础上,该研究评估了与不一致分析相关的结局指标。
总体而言,我们的研究支持PCR与C&S在阳性病例中的良好一致性(基线时为95.32%,研究结束时(EOS)为88.06%),但在阴性病例中发现了一些不一致性(基线时为38.30%,EOS时为62.91%)。健康人群子研究中的阴性百分比一致性(NPA)为70.16%。对不一致结果的进一步分析显示,与接受C&S阳性感染治疗的患者相比,接受PCR阳性感染治疗的有症状患者临床结局有改善趋势(77.45%对71.42%),微生物根除率更高(53.92%对50%)。关于抗菌药物使用和微生物学方面的额外分析显示,PCR组接受更多基于口服药物的治疗,而C&S组接受其他形式(肌肉注射或膀胱冲洗)。在结果不一致的情况下,PCR阳性但培养阴性的病例比PCR阴性但培养阳性的病例更多。
我们的临床效用研究数据表明,PCR指导的cUTI管理总体上优于传统的C&S,具有多个优势。PCR有可能通过尽早采用更窄谱的抗生素疗法、改善临床结局以及确保抗菌药物的有效选择来提高患者护理水平。PCR指导的管理计划在管理cUTI患者方面可能特别有益,可解决当前C&S指导的治疗方案偶尔会忽略的感染问题。