Cefadroxil

主要研究目的 评价中国健康成年研究参与者空腹及餐后条件下单次单剂量口服头孢羟氨苄干混悬剂受试制剂（规格：500mg/5mL，申办者：苏州第三制药厂有限责任公司）和参比制剂（商品名：Cefadroxil®，规格：500mg/5mL，持证商：Lupin Pharmaceuticals, Inc.）后的药代动力学特点和生物等效性。 次要研究目的 研究头孢羟氨苄干混悬剂受试制剂（规格：500mg/5mL）和参比制剂（商品名：Cefadroxil®，规格：500mg/5mL）在中国健康成年研究参与者中的安全性。

This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent effectiveness with improved safety of early transition from intravenous (IV) antimicrobial therapy to complex outpatient oral antimicrobial therapy (COpAT) across various infectious diseases (endovascular, bone and joint, skin and soft tissue, pulmonary, gastrointestinal, and genitourinary infections).
All patients referred for outpatient parenteral antimicrobial therapy (OPAT) will be evaluated by the research team with respect to inclusion/exclusion criteria. If determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT Trial. Once informed consent is obtained, patients will be randomized 2:1 using computer software into experimental or control (standard of care) group, respectively: Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides. Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital discharge. At the 6-week ID Clinic follow-up, patients will be asked to complete a patient satisfaction survey. The following 2 primary outcomes will be assessed: cure at 3 months using clinical (resolution of infection) and laboratory (improvement in inflammatory markers) parameters and adverse events related to antimicrobial therapy/vascular access complication or readmission at 3 months. The following secondary outcome will be assessed: patient satisfaction at 6 weeks. The experimental group is being compared to standard of care in current clinical practice.
As this is a pragmatic clinical trial, patients will not undergo additional invasive testing or procedures.