Clinical utility of PCR compared to conventional culture and sensitivity testing for the management of complicated urinary tract infections in adults: Part I. Assessment of clinical outcomes, investigator satisfaction scores, and turnaround times
Managing complicated urinary tract infections (cUTIs) poses significant challenges, often resulting in the overprescription of empiric antibiotics. This approach exposes patients to multiple antimicrobials and raises the risk of inadequate treatment efficacy. The purpose of this study is to assess a...
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creator | 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. |
description | Managing complicated urinary tract infections (cUTIs) poses significant challenges, often resulting in the overprescription of empiric antibiotics. This approach exposes patients to multiple antimicrobials and raises the risk of inadequate treatment efficacy. The purpose of this study is to assess and compare the clinical utility of molecular testing (PCR) versus conventional culture and sensitivity (C&S) in managing cUTI, to identify optimal management strategies for cUTI patients.
773 symptomatic adult patients with suspected cUTI diagnosis were randomized (1:1) into either the PCR-guided treatment group or the control group (C&S-guided) and followed up for 28 days. The primary outcome measure was the number (and percentage) of patients in each study arm with favorable clinical outcomes at the end of the study visit.
Overall, 468 patients completed all study procedures, and of those, data from 362 patients were analyzed (193 PCR arm, 169 C&S arm) for this Part 1 of the primary study analysis. Treatments guided by PCR results provided significantly better clinical outcomes compared to treatments guided by conventional C&S results (88.08 % vs. 78.11, p = 0.011), with a significantly shorter mean turnaround time (49.68 h vs. 104.4 h, p < 0.001), and a significant higher investigator satisfaction total score (23.95 ± 1.96 vs. 20.64 ± 4.12, p < 0.001).
This data demonstrated the clinical utility of PCR in improving therapeutic clinical outcomes and facilitating expedited, patient-specific management of cUTI for optimal patient care. Furthermore, this study showed a clear preference among investigators for PCR over C&S when making clinical decisions and managing patients with cUTI. |
doi_str_mv | 10.1016/j.diagmicrobio.2024.116601 |
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773 symptomatic adult patients with suspected cUTI diagnosis were randomized (1:1) into either the PCR-guided treatment group or the control group (C&S-guided) and followed up for 28 days. The primary outcome measure was the number (and percentage) of patients in each study arm with favorable clinical outcomes at the end of the study visit.
Overall, 468 patients completed all study procedures, and of those, data from 362 patients were analyzed (193 PCR arm, 169 C&S arm) for this Part 1 of the primary study analysis. Treatments guided by PCR results provided significantly better clinical outcomes compared to treatments guided by conventional C&S results (88.08 % vs. 78.11, p = 0.011), with a significantly shorter mean turnaround time (49.68 h vs. 104.4 h, p < 0.001), and a significant higher investigator satisfaction total score (23.95 ± 1.96 vs. 20.64 ± 4.12, p < 0.001).
This data demonstrated the clinical utility of PCR in improving therapeutic clinical outcomes and facilitating expedited, patient-specific management of cUTI for optimal patient care. Furthermore, this study showed a clear preference among investigators for PCR over C&S when making clinical decisions and managing patients with cUTI.]]></description><identifier>ISSN: 0732-8893</identifier><identifier>ISSN: 1879-0070</identifier><identifier>EISSN: 1879-0070</identifier><identifier>DOI: 10.1016/j.diagmicrobio.2024.116601</identifier><identifier>PMID: 39532029</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Anti-Bacterial Agents - therapeutic use ; Female ; Humans ; Male ; Microbial Sensitivity Tests ; Middle Aged ; Molecular Diagnostic Techniques - methods ; molecular diagnostic testing ; polymerase chain reaction ; Polymerase Chain Reaction - methods ; randomized controlled trial ; Treatment Outcome ; Urinary tract infection ; Urinary Tract Infections - diagnosis ; Urinary Tract Infections - drug therapy</subject><ispartof>Diagnostic microbiology and infectious disease, 2025-01, Vol.111 (1), p.116601, Article 116601</ispartof><rights>2024</rights><rights>Copyright © 2024. Published by Elsevier Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c1689-a1d10405ada5358aec290bbb18f07866a11a0a11ab943c47394ecbb8cb053dae3</cites><orcidid>0000-0002-9537-2274</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.diagmicrobio.2024.116601$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>315,782,786,3552,27931,27932,46002</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39532029$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Spangler, Frank L.</creatorcontrib><creatorcontrib>Williams, Cheau</creatorcontrib><creatorcontrib>Aberger, Michael E.</creatorcontrib><creatorcontrib>Wilson, Bradley A.</creatorcontrib><creatorcontrib>Ajib, Khaled</creatorcontrib><creatorcontrib>Gholami, Shahram S.</creatorcontrib><creatorcontrib>Goodwin, Henry N.</creatorcontrib><creatorcontrib>Park, Lauren Y.</creatorcontrib><creatorcontrib>Kardjadj, Moustafa</creatorcontrib><creatorcontrib>Derrick, DeAndre</creatorcontrib><creatorcontrib>Huard, Thomas K.</creatorcontrib><title>Clinical utility of PCR compared to conventional culture and sensitivity testing for the management of complicated urinary tract infections in adults: Part I. Assessment of clinical outcomes, investigator satisfaction scores, and turnaround times</title><title>Diagnostic microbiology and infectious disease</title><addtitle>Diagn Microbiol Infect Dis</addtitle><description><![CDATA[Managing complicated urinary tract infections (cUTIs) poses significant challenges, often resulting in the overprescription of empiric antibiotics. This approach exposes patients to multiple antimicrobials and raises the risk of inadequate treatment efficacy. The purpose of this study is to assess and compare the clinical utility of molecular testing (PCR) versus conventional culture and sensitivity (C&S) in managing cUTI, to identify optimal management strategies for cUTI patients.
773 symptomatic adult patients with suspected cUTI diagnosis were randomized (1:1) into either the PCR-guided treatment group or the control group (C&S-guided) and followed up for 28 days. The primary outcome measure was the number (and percentage) of patients in each study arm with favorable clinical outcomes at the end of the study visit.
Overall, 468 patients completed all study procedures, and of those, data from 362 patients were analyzed (193 PCR arm, 169 C&S arm) for this Part 1 of the primary study analysis. Treatments guided by PCR results provided significantly better clinical outcomes compared to treatments guided by conventional C&S results (88.08 % vs. 78.11, p = 0.011), with a significantly shorter mean turnaround time (49.68 h vs. 104.4 h, p < 0.001), and a significant higher investigator satisfaction total score (23.95 ± 1.96 vs. 20.64 ± 4.12, p < 0.001).
This data demonstrated the clinical utility of PCR in improving therapeutic clinical outcomes and facilitating expedited, patient-specific management of cUTI for optimal patient care. Furthermore, this study showed a clear preference among investigators for PCR over C&S when making clinical decisions and managing patients with cUTI.]]></description><subject>Adult</subject><subject>Aged</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Microbial Sensitivity Tests</subject><subject>Middle Aged</subject><subject>Molecular Diagnostic Techniques - methods</subject><subject>molecular diagnostic testing</subject><subject>polymerase chain reaction</subject><subject>Polymerase Chain Reaction - methods</subject><subject>randomized controlled trial</subject><subject>Treatment Outcome</subject><subject>Urinary tract infection</subject><subject>Urinary Tract Infections - diagnosis</subject><subject>Urinary Tract Infections - drug therapy</subject><issn>0732-8893</issn><issn>1879-0070</issn><issn>1879-0070</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2025</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkUtvFDEQhEcIRDaBv4AsThzYxZ735BZteESKRITgbPV4epZezdiL7Vkpf5wzbTaJOHKx-1D1VduVZW-V3Cip6g_7zUCwm8l415Pb5DIvN0rVtVTPspVqm24tZSOfZyvZFPm6bbviLDsPYS-lyrtSvszOiq4q2Natst_biSwZmMQSaaJ4L9wo7rbfhHHzATwOIjqe7RFtJGdZZ5YpLh4F2EEEtIEiHZMvYohkd2J0XsSfKGawsMOZfQmZcBPnRCYunix4dngwUZAd0SR24FHAwPhwKe7AR3GzEVchYAhPlMdl3RKZiOE9e44peAeRcwNECiP8xYlgnE-KtChvzJFuSSOx71X2YoQp4OuH-yL78enj9-2X9e3Xzzfbq9u1UXXbrUENSpayggGqomoBTd7Jvu9VO8qmrWtQCmQ6-q4sTNkUXYmm71vTy6oYAIuL7N2Je_Du18KL6pmCwWkCi24JulB529SyVRVLL09SrjUEj6M-eJr5n7SSOvWu9_rf3nXqXZ96Z_Obh5yln3F4sj4WzYLrkwD5tUdCr4MhtAYH8vz9enD0Pzl_AKjIzZM</recordid><startdate>202501</startdate><enddate>202501</enddate><creator>Spangler, Frank L.</creator><creator>Williams, Cheau</creator><creator>Aberger, Michael E.</creator><creator>Wilson, Bradley A.</creator><creator>Ajib, Khaled</creator><creator>Gholami, Shahram S.</creator><creator>Goodwin, Henry N.</creator><creator>Park, Lauren Y.</creator><creator>Kardjadj, Moustafa</creator><creator>Derrick, DeAndre</creator><creator>Huard, Thomas K.</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9537-2274</orcidid></search><sort><creationdate>202501</creationdate><title>Clinical utility of PCR compared to conventional culture and sensitivity testing for the management of complicated urinary tract infections in adults: Part I. Assessment of clinical outcomes, investigator satisfaction scores, and turnaround times</title><author>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.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1689-a1d10405ada5358aec290bbb18f07866a11a0a11ab943c47394ecbb8cb053dae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2025</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Microbial Sensitivity Tests</topic><topic>Middle Aged</topic><topic>Molecular Diagnostic Techniques - methods</topic><topic>molecular diagnostic testing</topic><topic>polymerase chain reaction</topic><topic>Polymerase Chain Reaction - methods</topic><topic>randomized controlled trial</topic><topic>Treatment Outcome</topic><topic>Urinary tract infection</topic><topic>Urinary Tract Infections - diagnosis</topic><topic>Urinary Tract Infections - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Spangler, Frank L.</creatorcontrib><creatorcontrib>Williams, Cheau</creatorcontrib><creatorcontrib>Aberger, Michael E.</creatorcontrib><creatorcontrib>Wilson, Bradley A.</creatorcontrib><creatorcontrib>Ajib, Khaled</creatorcontrib><creatorcontrib>Gholami, Shahram S.</creatorcontrib><creatorcontrib>Goodwin, Henry N.</creatorcontrib><creatorcontrib>Park, Lauren Y.</creatorcontrib><creatorcontrib>Kardjadj, Moustafa</creatorcontrib><creatorcontrib>Derrick, DeAndre</creatorcontrib><creatorcontrib>Huard, Thomas K.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Diagnostic microbiology and infectious disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Spangler, Frank L.</au><au>Williams, Cheau</au><au>Aberger, Michael E.</au><au>Wilson, Bradley A.</au><au>Ajib, Khaled</au><au>Gholami, Shahram S.</au><au>Goodwin, Henry N.</au><au>Park, Lauren Y.</au><au>Kardjadj, Moustafa</au><au>Derrick, DeAndre</au><au>Huard, Thomas K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical utility of PCR compared to conventional culture and sensitivity testing for the management of complicated urinary tract infections in adults: Part I. Assessment of clinical outcomes, investigator satisfaction scores, and turnaround times</atitle><jtitle>Diagnostic microbiology and infectious disease</jtitle><addtitle>Diagn Microbiol Infect Dis</addtitle><date>2025-01</date><risdate>2025</risdate><volume>111</volume><issue>1</issue><spage>116601</spage><pages>116601-</pages><artnum>116601</artnum><issn>0732-8893</issn><issn>1879-0070</issn><eissn>1879-0070</eissn><abstract><![CDATA[Managing complicated urinary tract infections (cUTIs) poses significant challenges, often resulting in the overprescription of empiric antibiotics. This approach exposes patients to multiple antimicrobials and raises the risk of inadequate treatment efficacy. The purpose of this study is to assess and compare the clinical utility of molecular testing (PCR) versus conventional culture and sensitivity (C&S) in managing cUTI, to identify optimal management strategies for cUTI patients.
773 symptomatic adult patients with suspected cUTI diagnosis were randomized (1:1) into either the PCR-guided treatment group or the control group (C&S-guided) and followed up for 28 days. The primary outcome measure was the number (and percentage) of patients in each study arm with favorable clinical outcomes at the end of the study visit.
Overall, 468 patients completed all study procedures, and of those, data from 362 patients were analyzed (193 PCR arm, 169 C&S arm) for this Part 1 of the primary study analysis. Treatments guided by PCR results provided significantly better clinical outcomes compared to treatments guided by conventional C&S results (88.08 % vs. 78.11, p = 0.011), with a significantly shorter mean turnaround time (49.68 h vs. 104.4 h, p < 0.001), and a significant higher investigator satisfaction total score (23.95 ± 1.96 vs. 20.64 ± 4.12, p < 0.001).
This data demonstrated the clinical utility of PCR in improving therapeutic clinical outcomes and facilitating expedited, patient-specific management of cUTI for optimal patient care. Furthermore, this study showed a clear preference among investigators for PCR over C&S when making clinical decisions and managing patients with cUTI.]]></abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>39532029</pmid><doi>10.1016/j.diagmicrobio.2024.116601</doi><orcidid>https://orcid.org/0000-0002-9537-2274</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adult Aged Anti-Bacterial Agents - therapeutic use Female Humans Male Microbial Sensitivity Tests Middle Aged Molecular Diagnostic Techniques - methods molecular diagnostic testing polymerase chain reaction Polymerase Chain Reaction - methods randomized controlled trial Treatment Outcome Urinary tract infection Urinary Tract Infections - diagnosis Urinary Tract Infections - drug therapy |
title | Clinical utility of PCR compared to conventional culture and sensitivity testing for the management of complicated urinary tract infections in adults: Part I. Assessment of clinical outcomes, investigator satisfaction scores, and turnaround times |
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