Pilot study of linezolid for early syphilis treatment
利奈唑胺治疗早期梅毒的初步研究
基本信息
- 批准号:10575509
- 负责人:
- 金额:$ 23.72万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-11-22 至 2024-10-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdherenceAdultAftercareAllergicAnimalsAntibiotic TherapyAntibioticsBacteriaBenzathine PenicillinCase SeriesCefiximeCeftriaxoneCephalosporinsCerebrospinal FluidClinicClinicalClinical ResearchClinical TrialsCollectionControl GroupsCountryDataData AnalysesData CollectionDevelopmentDoseDoxycyclineDrug KineticsDrug resistance in tuberculosisEarly treatmentEnrollmentFDA approvedFundingGenerationsGlobus PallidusGram-Positive BacteriaHIV InfectionsHourHumanHypersensitivityIn VitroIncidenceIndividualInfectious Skin DiseasesInjectableInjectionsInternationalIntramuscularLesionLinezolidMinimum Inhibitory Concentration measurementModelingMonitorOralOral AdministrationOral cavityOryctolagus cuniculusOutcomeOxazolidinonesParticipantPatientsPenicillin AllergyPenicillin GPenicillinsPersonsPeruPhasePilot ProjectsPneumoniaPredispositionPregnancyRandomizedRandomized, Controlled TrialsRecommendationRegimenResearchSafetySamplingSchemeSerologySerology testSiteSpecimenStreptococcusSyphilisSystemTestingTetracyclinesTimeToxic effectTrainingTreponema pallidumUnited States National Institutes of HealthVancomycin resistant enterococcusWorkalternative treatmentarmbactericideclinical efficacyclinical research sitecostdata disseminationeffective therapyefficacy evaluationexperienceexperimental armexperimental studyfollow-uphealinginstrumentmen who have sex with menmethicillin resistant Staphylococcus aureusmicrobicidenovelnovel strategiesopen labelparticipant enrollmentpilot trialrecruitresearch clinical testingresponsesuccesstreatment duration
项目摘要
PROJECT ABSTRACT
The proposed pilot project will evaluate the efficacy of linezolid in the treatment of early syphilis. Syphilis rates
are increasing both in the US and internationally. Incidence is higher among men who have sex with men and in
individuals with HIV infection. Currently, injectable penicillin is used to treat syphilis; however, injectable penicillin
is not available in many countries. Doxycycline, tetracycline, and ceftriaxone are alternative treatments for non-
pregnant patients who are allergic to penicillin. Although existing treatment alternatives are based on clinical
experience, there are a limited number of small clinical trials and case series. Each non-penicillin treatment
poses clinical challenges for administration and compliance. Repurposing already approved and safe antibiotics
could bring new, safe, and efficacious antibiotic treatment options into the clinic faster and cut down on
development costs. This pilot project focuses on studying the potential efficacy of the FDA-approved antibiotic
linezolid.
In this proposal, we will test the clinical efficacy and microbicidal activity of linezolid to establish its use as a
syphilis treatment. We will build upon our successful syphilis clinical studies to conduct a randomized, open-
label, non-comparative pilot study to evaluate the efficacy of two linezolid dosing schemes (600mg, twice a day,
for ten days or for five days) in patients. We will enroll 60 participants with early syphilis from two clinical sites in
Peru. We will follow the participants to monitor clinical progress and serological response (RPR titer) at 7, 30,
90, 180, 270 and 360 days. Our hypothesis is that linezolid will be efficacious in treating early syphilis
demonstrated by four-fold decrease in RPR titer, from enrollment to three or six months after treatment
administration, and by microbicidal activity against multiple Treponema pallidum isolates.
The two specific aims of our proposal are: AIM 1: To evaluate the efficacy of linezolid for the treatment of early
syphilis. AIM 2: Evaluate the susceptibility of Treponema pallidum historical and novel strains to linezolid.
The two-year project has four phases. Phase I will last four months and will involve the development of study
instruments and staff training on recruitment, enrollment, and data collection. Phase II will last 12 months and
will involve recruitment and enrollment of patients and collection of clinical specimens. Phase III will last 24
months, but will proceed simultaneously with Phase II, and include the patient follow-up period. Phase IV will
last three months and includes data analysis and dissemination.
项目摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Jeffrey David Klausner其他文献
Jeffrey David Klausner的其他文献
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{{ truncateString('Jeffrey David Klausner', 18)}}的其他基金
Evaluating STI screening and antimicrobial resistance in Neisseria gonorrhoeae among PrEP users in Vietnam
评估越南 PrEP 使用者中性传播感染筛查和淋病奈瑟菌耐药性
- 批准号:
10389089 - 财政年份:2021
- 资助金额:
$ 23.72万 - 项目类别:
Evaluating STI screening and antimicrobial resistance in Neisseria gonorrhoeae among PrEP users in Vietnam
评估越南 PrEP 使用者中性传播感染筛查和淋病奈瑟菌耐药性
- 批准号:
10343849 - 财政年份:2021
- 资助金额:
$ 23.72万 - 项目类别:
Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
比较头孢克肟与青霉素 G 治疗早期梅毒疗效的临床试验
- 批准号:
10417271 - 财政年份:2020
- 资助金额:
$ 23.72万 - 项目类别:
Clinical Study of STI Screening to Prevent Adverse Birth and Newborn Outcomes
性传播感染筛查预防不良分娩和新生儿结局的临床研究
- 批准号:
10555240 - 财政年份:2020
- 资助金额:
$ 23.72万 - 项目类别:
Clinical Study of STI Screening to Prevent Adverse Birth and Newborn Outcomes
性传播感染筛查预防不良分娩和新生儿结局的临床研究
- 批准号:
10385627 - 财政年份:2020
- 资助金额:
$ 23.72万 - 项目类别:
Clinical trial comparing the effectiveness of cefixime versus penicillin G for treatment of early syphilis
比较头孢克肟与青霉素 G 治疗早期梅毒有效性的临床试验
- 批准号:
10079905 - 财政年份:2020
- 资助金额:
$ 23.72万 - 项目类别:
Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
比较头孢克肟与青霉素 G 治疗早期梅毒疗效的临床试验
- 批准号:
10652990 - 财政年份:2020
- 资助金额:
$ 23.72万 - 项目类别:
Clinical Study of STI Screening to Prevent Adverse Birth and Newborn Outcomes
性传播感染筛查预防不良分娩和新生儿结局的临床研究
- 批准号:
10322132 - 财政年份:2020
- 资助金额:
$ 23.72万 - 项目类别:
Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
比较头孢克肟与青霉素 G 治疗早期梅毒疗效的临床试验
- 批准号:
10392825 - 财政年份:2020
- 资助金额:
$ 23.72万 - 项目类别:
Clinical study of STI screening to prevent adverse birth and newborn outcomes
性传播感染筛查预防不良分娩和新生儿结局的临床研究
- 批准号:
10082426 - 财政年份:2020
- 资助金额:
$ 23.72万 - 项目类别:
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