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 WITHCOMPLICATED URINARY TRACT INFECTIO

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,0 个研究点目标入组 7 人开始时间: 2013年2月14日最近更新: 2023年9月4日

试验速览

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•1. PATIENT IS ≥ 18 YEARS OF AGE ON THE DAY OF SIGNING INFORMED CONSENT (VISIT 1).
•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 THE PATIENT´S LEGAL REPRESENTATIVE UNDERSTANDS THE STUDY PROCEDURES, ALTERNATIVE TREATMENTS AVAILABLE, AND RISKS INVOLVED WITH THE STUDY, AND VOLUNTARILY AGREES TO PARTICIPATE BY GIVING WRITTEN INFORMED CONSENT FOR THE TRIAL. THE SUBJECT MAY ALSO PROVIDE CONSENT FOR FUTURE BIOMEDICAL RESEARCH. HOWEVER, THE SUBJECT MAY PARTICIPATE IN THE MAIN TRIAL WITHOUT PARTICIPATING IN FUTURE BIOMEDICAL RESEARCH.
•SEXUALLY ACTIVE FEMALES OF CHILDBEARING POTENTIAL WITH A NEGATIVE URINE PREGNANCY TEST ARE ELIGIBLE FOR ENROLLMENT; HOWEVER, THIS MUST BE FOLLOWED UP WITH A CONFIRMED NEGATIVE SERUM PREGNANCY TEST ((3-HCG) WITHIN 48 HOURS FOLLOWING THE-SCREENING VISIT. A FEMALE WHO IS OF REPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENT OR USE (OR HAVE THEIR PARTNER USE) A MEDICALLY ACCEPTABLE EFFECTIVE METHOD OF BIRTH CONTROL FOR I MONTH AFTER STUDY ENTRY. FEMALE PATIENTS IN REGIONS IN WHICH ABSTINENCE IS NOT A LOCALLY ACCEPTABLE METHOD OF CONTRACEPTION MUST USE ANOTHER MEDICALLY ACCEPTABLE EFFECTIVE BIRTH CONTROL METHOD.

•1. PATIENT HAS AN INFECTION WHICH SHOULD BE MANAGED BY STAGED ABDOMINAL REPAIR (STAR) OR OPEN ABDOMEN TECHNIQUE. (FOR A DESCRIPTION OF VARIOUS SURGICAL PROCEDURES, PLEASE REFER TO [2]).
•2. PATIENT WITH AN APACHE II SCORE >30 (SEE SECTION 3.2.1.6) AT SCREENING.
•3. PATIENT HAS RECEIVED ANY AMOUNT OF EFFECTIVE ANTIBIOTIC THERAPY (DEFINED AS THERAPY KNOWN TO BE ACTIVE AGAINST THE IDENTIFIED PATHOGEN) AFTER OBTAINING THE CULTURE FOR ADMISSION TO THIS STUDY (ADMISSION CULTURE) AND PRIOR TO THE ADMINISTRATION OF THE FIRST DOSE OF IV STUDY THERAPY.
•4. PATIENT HAS AN INFECTION WHICH HAS BEEN TREATED WITH >24 HOURS OF SYSTEMIC ANTIBIOTIC THERAPY KNOWN TO BE EFFECTIVE AGAINST THE PRESUMED OR DOCUMENTED ETIOLOGIC PATHOGEN(S) WITHIN THE 72-HOUR PERIOD IMMEDIATELY PRIOR TO CONSIDERATION FOR ENTRY INTO THE STUDY (E.G., >3 DOSES OF AN EVERY 8 HOUR [Q8H] ANTIBIOTIC BEFORE ENROLLMENT).
•NOTE: PATIENTS ON PROPHYLACTIC ANTIBIOTIC THERAPY SHOULD BE ENROLLED ONLY IF
•THEIR ADMISSION CULTURE IS CONFIRMED TO BE POSITIVE FOR AT LEAST 1 GRAM-NEGATIVE ENTERIC(S) AND/OR ANAEROBIC PATHOGEN(S) COMMONLY ISOLATED IN IAI.

发起方

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