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Controlling Drug Resistant Gonorrhea with Real-Time PCR Susceptibility Testing

Controlling Drug Resistant Gonorrhea with Real-Time PCR Susceptibility Testing
通过实时 PCR 药敏测试控制耐药性淋病
批准号:
8772288
负责人:
Jeffrey David Klausner
金额:
$16.72万
依托单位国家:
美国
项目类别:
财政年份:
2014
资助国家:
美国
项目状态:
已结题
起止时间:
2014-08-15 至 2016-07-31
关键词:
AddressAgarAntibiotic TherapyAntibioticsAntimicrobial ResistanceAntimicrobial susceptibilityAzithromycinBiological AssayBusinessesCaliforniaCeftriaxoneCell WallCenters for Disease Control and Prevention (U.S.)CephalosporinsCharacteristicsCiprofloxacinClinicalClinical ManagementCounselingCountyDNADetectionDiagnosisDrug resistanceEcologyEnsureErythromycinFinlandFluoroquinolonesFrequenciesGene MutationGene TargetingGeneticGonorrheaHealth Knowledge, Attitudes, PracticeHealth ServicesHumanIndividualInfectionInjectableJapanLaboratoriesLos AngelesMacrolide-resistanceMaintenanceManufacturer NameMedicineMethodsMinimum Inhibitory Concentration measurementMolecularMonitorMorbidity - disease rateMulti-Drug ResistanceMutationMycobacterium tuberculosisNeisseria gonorrhoeaeNucleic Acid Amplification TestsNucleic AcidsOralOutcome StudyPatientsPenicillinsPerformancePolymerase Chain ReactionPredispositionProteinsProtocols documentationProviderPublic HealthRNA amplificationRecommendationRegulationRelative (related person)ResearchResistanceRisk ReductionSelection for TreatmentsSexually Transmitted DiseasesSpecimenStaphylococcus aureusStreptococcal InfectionsSurveysTechniquesTestingTetracyclinesTimeTreatment FailureUnited Statesantimicrobial drugbaseclinical practicecondomsdrug developmentexperiencefluoroquinolone resistancemenmetropolitanmolecular markermortalitynovelnovel strategiesprimary outcomeprogramspublic health relevanceresponsescreeningsecondary outcomesexsurveillance datatrendvigilance

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DESCRIPTION (provided by applicant): The proposed research represents a novel approach to controlling the spread of drug-resistant Neisseria gonorrhea through the use of real-time polymerase chain reaction (PCR) to determine antimicrobial susceptibility of an individual infection and reduce the unnecessary use of broad spectrum antibiotics. Over the past 75 years, gonorrhea has become increasingly resistant to antimicrobial therapy. The continued emergence of drug-resistance in gonorrhea has many experts stating that gonorrhea might become an untreatable "superbug". Yet, the response to this serious public health problem continues to rely on clinical vigilance for treatment failure, partner treatment, maintenance of culture-based surveillance, risk-reduction counseling, condom use, repeat screening and calls for novel antimicrobial drug development. The use of molecular assays for antimicrobial susceptibility determination has been successfully used to treat M. tuberculosis and Staphylococcus aureus infections, but not yet with gonorrhea. The use of real-time PCR to determine antimicrobial susceptibility could be a "game changer" that alters the course of sexually transmitted disease medicine and leads to a critical reduction in gonorrhea drug-resistance. There are three specific aims to our proposal: 1) we will verify the real-time PCR assay in the Los Angeles County Public Health Laboratory to enable its clinical use and comply with federal regulations providing for the use of laboratory tests in clinical practice. 2) We will develop an antimicrobial susceptibility testing program that ensures that all specimens in Los Angeles County tested at the Public Health Laboratory for gonorrhea will also be tested for antimicrobial susceptibility and those results provided to the testing clinicians within two business days to use to guide antibiotic treatment. 3) We will evaluate the effect of the new assay among clinicians treating their patients with gonorrhea, including monitoring the turn-around time of susceptibility results relative to treatment, treatment selection, and surveying clinicians regarding their knowledge, attitudes, and practices regarding the molecular susceptibility results. The primary outcome of this study is the difference in the proportion of gonorrhea cases treated with an extended-spectrum cephalosporin before and after the provision of gonorrhea antimicrobial susceptibility results. Based on prior research, we hypothesize a 50% reduction in extended-spectrum cephalosporin use from 95% to 50%. Secondary outcomes will explore the association of non-extended-spectrum cephalosporin use based on both provider and case- patient characteristics. Overall, the results of this study will potentially transform the management of gonorrhea and impact the frequency of drug-resistant gonorrhea.
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