Imaging Bacterial Infections in Vivo: First in Man Studies

项目摘要/摘要 感染是几乎所有医疗器械的主要并发症。据估计，200万名患者 在美国每年都会发生医院感染，疾控中心估计这些感染的财务影响 每年感染人数超过50亿美元。这些感染中至少有一半与医疗保健直接相关 设备。最常见的是，对与医疗器械相关的感染的诊断是基于 临床标准，包括体检和微生物培养，这是有问题的，因为它只能 检测治疗难度较大的晚期感染。直接对细菌感染进行成像一直很困难 由于目前的成像技术(例如，超声、CT、MRI、PET)仅限于对软组织改变进行成像 或炎症与感染相一致，但不是感染的诊断。微生物医药公司是一家新兴的公司 专注于开发新的成像和抗生素化合物，将导致改善患者护理 在细菌感染的诊断和治疗方面。本提案中要解决的当前技术是 新的麦芽糊精氟-18显像剂将能够检测与骨科相关的感染 植入物通过PET成像。这项提议的目标是在人类研究MH18F中率先进行。我们已经选择了 将与骨科植入物相关的感染成像作为最初的商业战略。如果成功，则 商业化的技术将使临床医生能够在更早的阶段识别患有细菌感染的患者， 允许治疗，从而降低发病率、死亡率和医疗费用。

Project Summary/Abstract Infection is the major complication of virtually all medical devices. It is estimated that 2 million patients acquire a nosocomial infection in the US every year and the CDC estimates that the financial impact of these infections exceeds 5 billion dollars annually. At least half of these infections are directly associated with medical devices. Most commonly, the diagnosis of an infection associated with a medical device is made on the basis of clinical criteria including the physical exam and microbial cultures, which is problematic because it can only detect late stage infections that are challenging to treat. Directly imaging bacterial infections has been difficult as current imaging technologies (e.g., ultrasound, CT, MRI, PET) are limited to imaging either soft tissue changes or inflammation consistent with, but not diagnostic of, infection. Microbial Medical Inc. is an emerging company focused on the development of novel imaging and antibiotic compounds that will lead to improved patient care in the diagnosis and therapy of bacterial infections. The current technology to be addressed in this proposal is a new maltodextrin fluorine-18 imaging agent that will be able to detect infections associated with orthopedic implants by PET imaging. The goal of this proposal is to perform first in man studies MH18F. We have selected imaging of infections associated with orthopedic implants as an initial business strategy. If successful, the technology commercialized will allow clinicians to identify patients with bacterial infections at an earlier stage, permitting treatment, and thus reduce morbidity, mortality and healthcare costs.