A PHASE II, RANDOMIZED, ACTIVE COMPARATOR-CONTROLLED CLINICAL TRIAL TO STUDY THE SAFETY, TOLERABILITY, AND EFFICACY OF MK-7655 + IMIPENEM/CILASTATIN VERSUS IMIPENEM/CILASTATIN ALONE IN PATIENTS WITH COMPLICATED URINARY TRACT INFECTIO

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,0 个研究点目标入组 21 人开始时间: 2012年11月23日最近更新: 2023年9月4日

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•1.PATIENT IS ≥ 18 YEARS OF AGE ON DAY OF SIGNING INFORMED CONSENT.
•NOTE: ADULTS ARE THE INTENDED STUDY POPULATION FOR THIS PROTOCOL. SUBJECTS UNDER THE AGE OF LEGAL CONSENT WILL BE EXCLUDED FROM PARTICIPATION IN THIS STUDY.
•2.PATIENT OR PARIENT’S LEGAL REPRESENTATIVE UNDERSTANDS THE STUDY PROCEDURES, ALTERNATIVE TREATMENTS AVAILABLE, AND RISKS INVOLVED WITH THE STUDY, AND VOLUNTARILY AGREES TO PARTICIPE BY GIVING WRITTEN INFORMED CONSENT FOR THE TRIAL. THE SUBJECT MAY ALSO PROVIDE CONSENT/ASSENT FOR FUTURE BIOMEDICAL RESEARCH. HOWEVER, THE SUBJECT MAY PARTICIPATE IN THE MAIN TRIAL WITHOUT PARTICIPATING IN FUTURE BIOMEDICAL RESEARCH.
•3.PATIENT HAS BEEN DOMICILED IN A HEALTH CARE FACILITY (E.G., HOSPITAL, NURSING HOME) FOR AL LEAST 48 HOURS WITHIN THE PROCEDING 30 CALENDAR DAYS PRIOR TO SIGNING INFORMED CONSENT.
•4.SEXUALLY ACTIVE FEMALES OF CHILDBEARING POTENTIAL WITH A NEGATIVE URINE PREGNANCY TEST ARE ELIGIBLE FOR ENROLLEMENT; HOWEVER, THIS MUST BE FOLLOWED UP WITH A CONFIRMEDNEGATIVE SERUM PREGNANCY TEST (Β-HCG) AS SOON AS POSSIBLE (WITHIN 48 HOURS OF THE SCREENING VISIT).

•1.PATIENT HAS COMPLETE OBSTRUCTION OF ANY PORTION OF THE URINARY TRACT (REQUIRING A PERMANENT INDWELLING URINARY CATHETER OR INSTRUMENTATION), HAS A KNOWN ILEAL LOOP, OR INTRACTABLE VESICO-URETRAL REFLUX.
•2.PATIENT HAS A CUTI IN WHOM A TEMPORARY INDWELLING URINARY CATHETER IS IN PLACE AND CANNOT BE REMOVED AT STUDY ENTRY.
•NOTE: ALL INDWELLING URINARY CATHETERS MUST BE REMOVED PRIOR TO THE START OF IV STUDY THERAPY. IT IS ALSO ANTICIPATED THAT AN INDWELLING URINARY CATHETER WILL NOT BE REINSERTED DURING THE STUDY (AT LEAST WHILE ON IV STUDY THERAPY).
•3.PATIENT HAS A PERINEPHRIC OR INTRARENAL ABSCESS OR KNOWN OR SUSPECTED PROSTATITIS.
•4.PATIENT HAS AN UNCOMPLICATED UTI (E.G., A FEMALE PATIENT WITH URINARY FREQUENCY, URGENCY OR PAIN/DISCOMFORT WITHOUT ANY RISK FACTORS FOR INFECTION AS OUTLINED IN INCLUSION CRITERIA # 5B).
•5.PATIENT HAS ANY HISTORY OF RECENT ACCIDENTAL TRAUMA TO THE PELVIS OR URINARY TRACT.
•6.PATIENT HAS RECEIVED ANY AMOUNT OF EFFECTIVE ANTIBIOTIC THERAPY (DEFINED AS THERAPY KNOWN TO BE ACTIVE AGAINST THE IDENTIFIED UROPATHOGEN) AFTER OBTAINING THE URINE CULTURE FOR ADMISSION TO THIS STUDY (ADMISSION URINE CULTURE) AND PRIOR TO THE ADMINISTRATION OF THE FIRST DOSE OF IV STUDY THERAPY.

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,