Department of Medical Microbiology, Amsterdam Universitair Medische Centra, University of Amsterdam, Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands.
Department of Clinical Chemistry, Amsterdam Universitair Medische Centra, University of Amsterdam, Amsterdam, The Netherlands.
Clin Infect Dis. 2021 Dec 6;73(11):e3867-e3875. doi: 10.1093/cid/ciaa1709.
Diagnosing urinary tract infections (UTIs) in nursing home residents is complex, as specific urinary symptoms are often absent and asymptomatic bacteriuria (ASB) is prevalent. The aim of this study was to assess the sensitivity of blood C-reactive protein (CRP) and procalcitonin (PCT), measured by point-of-care tests (PoCTs), to diagnose UTIs in this setting.
Elderly residents (≥65 years old) with a suspected UTI were recruited from psychogeriatric, somatic, or rehabilitation wards across 13 participating nursing homes. CRP and PCT were tested simultaneously in the same study participants. To assess the tests' sensitivities, a stringent definition of "true" UTI was used that included the presence of symptoms, urinary leucocytes, a positive urine culture, and symptom resolution during antibiotic treatment covering isolated uropathogen(s). The original sample size was 440 suspected UTI episodes, in order to detect a clinically relevant sensitivity of at least 65% when calculated using the matched analysis approach to compare both PoCTs.
After enrollment of 302 episodes (68.6% of the planned sample size), an unplanned and funder-mandated interim analysis was done, resulting in premature discontinuation of the study for futility. For 247 of 266 eligible episodes, all mandatory items required for the true UTI definition (92.9%) were available. In total, 49 episodes fulfilled our stringent UTI definition (19.8%). The sensitivities of CRP (cut-off, 6.5 mg/L) and PCT (cut-off, 0.025 ng/mL) were 52.3% (95% confidence interval [CI], 36.7-67.5%) and 37.0% (95% CI, 23.2-52.5%), respectively.
Our results indicate that CRP and PCT are not suitable tests for distinguishing UTI and ASB in nursing home residents.
Netherlands Trial Registry NL6293.
在养老院中诊断尿路感染(UTI)较为复杂,因为特定的尿路症状往往不存在,且无症状菌尿症(ASB)较为普遍。本研究旨在评估即时检验(PoCT)检测血 C 反应蛋白(CRP)和降钙素原(PCT)在该环境下诊断 UTI 的敏感性。
从参与的 13 家养老院的精神科、躯体科或康复病房招募疑似 UTI 的老年居民(≥65 岁)。在同一名研究参与者中同时检测 CRP 和 PCT。为了评估这些检测的敏感性,采用了严格的“真正”UTI 定义,该定义包括症状、尿白细胞、阳性尿培养以及抗生素治疗期间症状缓解,抗生素治疗覆盖了孤立的尿路病原体。原始样本量为 440 例疑似 UTI 发作,目的是使用匹配分析方法比较两种 PoCT 来检测至少 65%的临床相关敏感性。
在纳入 302 例发作(计划样本量的 68.6%)后,进行了一次计划外的、受资助者要求的中期分析,导致研究因无效而提前终止。对于 266 例合格发作中的 247 例,所有满足严格 UTI 定义所需的必需项目(92.9%)均可用。共有 49 例发作符合我们严格的 UTI 定义(19.8%)。CRP(临界值 6.5mg/L)和 PCT(临界值 0.025ng/mL)的敏感性分别为 52.3%(95%置信区间[CI],36.7-67.5%)和 37.0%(95%CI,23.2-52.5%)。
我们的结果表明 CRP 和 PCT 不适用于区分养老院居民的 UTI 和 ASB。
荷兰临床试验注册 NL6293。