Development of a Novel Therapeutic Approach for Cryptococcal Meningitis
Development of a Novel Therapeutic Approach for Cryptococcal Meningitis
批准号:
8977469
负责人:
Shivanand P Lad
金额:
$22.49万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2015
资助国家:
美国
项目状态:
已结题
起止时间:
2015-07-17 至 2016-12-31
关键词:
Adverse effectsAffectAmphotericin BAnimal ModelAnimalsAntibioticsAntifungal AgentsAntifungal TherapyAreaBasidiomycotaBloodBlood CirculationCathetersCentral Nervous System InfectionsCephalicCerebrospinal FluidCessation of lifeChairpersonClinicalClinical TrialsCohort StudiesCollaborationsColony-forming unitsCombined Modality TherapyCommunicable DiseasesCryptococcal MeningitisCryptococcusCryptococcus neoformansCustomDataDevelopmentDevice or Instrument DevelopmentDevicesDiagnosisDoctor of PhilosophyDrug Delivery SystemsDrug resistanceEffectivenessEnsureEquilibriumExcisionExclusionFiltrationFlucytosineGoalsGuidelinesHIVHourImmunocompromised HostIn VitroInflammatoryIntensive Care UnitsInterventionInterviewIntravenousInvadedLifeLocal TherapyLongevityMeasurementMechanicsMedical DeviceModelingMonitorMorbidity - disease rateNeuraxisNeurologicNeurosurgeonOpportunistic InfectionsOralOrgan TransplantationOrganismOryctolagus cuniculusOutcomePathway interactionsPatientsPhaseProceduresProcessPumpRegimenResearchSafetySamplingSmall Business Technology Transfer ResearchSpecialistSpeedSpinalStagingSurfaceSystemTestingTimeTranslatingUniversitiesWorkbasecerebrospinal fluid flowclinical practicedesignexperiencein vitro testingin vivoinnovationmortalitynervous system disorderneurosurgerynovel strategiesnovel therapeutic interventionnovel therapeuticspathogenpreclinical studypressureprototypepublic health relevanceradiologiststandard of care
中文摘要
英文摘要
DESCRIPTION (provided by applicant): When Cryptococcus is manifested as Cryptococcal meningitis (CM), it creates a large burden of mortality and morbidity to the patient and is very difficult for the clinician to treat. There are now 10,000 US cases and over 1 million cases of CM worldwide annually, with estimated deaths of 700,000 per year. CM is caused when Cryptococcus neoformans, a basidiomycete fungal pathogen, invades the central nervous system (CNS), It is seen most commonly in immunocompromised patients, such as those with HIV or post organ-transplant. Current treatments include anti-fungal agents that have limited effectiveness in penetrating the CNS and various systemic side effects. Reduction in pathogen burden within the first 14 days of therapy is the best predictor of reduced morbidity and mortality. Minnetronix, a medical device development and manufacturing company, proposes this Phase I STTR in collaboration with experts from the Infectious Diseases and Neurosurgery Departments at Duke University. Phase I will focus on developing Neurapheresis, a cerebrospinal fluid (CSF) processing platform, that will rapidly clear specific pathogens for treating life-threatening infections of the central nervous system (CNS). The objective of the proposed project is to develop a tailored system to target and remove C. neoformans from the CSF and to evaluate its reduction in a CM animal model. Specific Aim 1 will focus on conducting in vitro testing using a design matrix tailored for Cryptococcus exclusion. Longevity and mechanical testing will be performed to ensure safety and reliability. Specific Aim 2 will evaluate
the in vivo reduction of CSF fungal CFUs in a validated rabbit CM model. In summary, Neurapheresis is an innovative, new therapeutic option that provides direct access to the CSF and creates active circulation combined with targeted pathogen removal. This treatment is intended to be complementary and does not replace standard of care (SOC) interventions with systemic, intravenous antifungal regimens. Successful completion of this Phase I STTR will provide Minnetronix with the data to justify broader preclinical studies and development of a GLP-quality system for treatment of CM in Phase II. During Phase II, concurrent regulatory, clinical planning, and reimbursement work will be conducted to prepare for an investigational device exemption (IDE) application at the end of Phase II. The long-term goal of the project is to develop a novel therapeutic approach that rapidly reduces CSF fungal burden and translates to reduced morbidity and mortality for CM patients worldwide.
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会议论文
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项目类别:
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依托单位:
海外基金