AN OPEN-LABEL, RANDOMIZED, MULTCENTER, PHASE III STUDY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI, FORMERLY CAZ104) AND BEST AVALABLE THERAPY FOR THE TREATMENT OF INFECTIONS DUE TO CEFTAZIDIME RESISTANT GRAM-NEGATIVE PATHOGENS

AstraZeneca AB,0 个研究点目标入组 9 人开始时间: 2013年3月21日最近更新: 2023年9月4日

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暂无简介。

•ALL PATIENTS
•1. PATIENT MUST BE ≥ 18 AND ≤ 90 YEARS OF AGE
•2. PATIENT MUST PROVIDE A SIGNED WRITTEN INFORMED CONSENT PRIOR TO ANY STUDY-SPECIFIC PROCEDURES.
•3. FEMALE PATIENT IS AUTHORIZED TO PARTICIPATE IN THIS CLINICAL STUDY IF SHE MEETS THE
•FOLLOWING CRITERIA:
•(A) HAS BEEN SURGICALLY STERILIZED OR POSTMENOPAUSAL FOR AT LEAST 1 YEAR OR HER SEXUAL PARTNER HAS HAD A VASECTOMY
•(B) IS OF CHILDBEARING POTENTIAL AND ALL OF THE FOLLOWING CONDITIONS ARE MET:
•. HAD NORMAL MENSTRUAL PERIODS FOR THE 3 MONTHS PRIOR TO STUDY ENTRY, AND
•. HAS A NEGATIVE SERUM PREGNANCY TEST (SERUM Β-HUMAN CHORIONIC GONADOTROPIN [Β-HCG]) WITHIN 1 DAY PRIOR TO STUDY ENTRY (IF THE RESULTS OF THE SERUM Β-HCG CANNOT BE OBTAINED PRIOR TO DOSING OF THE IP, A PATIENT MAY BE ENROLLED ON THE BASIS OF A NEGATIVE URINE PREGNANCY TEST, THOUGH SERUM (Β-HCG MUST STILL BE OBTAINED), AND
•. MUST BE WILLING, DURING TREATMENT AND FOR AT LEAST 28 DAYS AFTER LAST INFUSION OF STUDY THERAPY, TO PRACTICE HIGHLY EFFECTIVE METHODS OF BIRTH CONTROL SUCH AS INTRAUTERINE DEVICE (WITH COPPER BANDED COIL), LEVONORGESTREL INTRAUTERINE SYSTEM (EG, MIRENE®), MEDROXYPROGESTERONE INJECTIONS (DEPO-PROVERA®), OR REMAIN SEXUALLY ABSTINENT.

•ALL PATIENTS
•1. PATIENT HAS AN APACHE II SCORE >30
•2. PATIENT HAS AN INFECTION DUE TO GRAM-NEGATIVE BACTERIAL SPECIES THAT IS UNLIKELY TO RESPOND TO CAZ-AVI TREATMENT (EG, ACINETOBACTER SPP., STENOTROPHOMONAS SPP.)
•3. PATIENT HAS A RAPIDLY PROGRESSIVE OR TERMINAL ILLNESS, INCLUDING ACUTE HEPATIC FAILURE OR RESPIRATORY FAILURE WITH A HIGH RISK OF MORTALITY DUE TO OTHER CAUSES
•4. PATIENT HAS A HISTORY OF SERIOUS ALLERGY, HYPERSENSITIVITY (EG, ANAPHYLAXIS), OR ANY SERIOUS REACTION TO CARBAPENEM OR CEPHALOSPORIN OR OTHER Β-LACTAM ANTIBIOTICS
•5. PATIENT IS UNLIKELY TO RESPOND TO 5 TO 21 DAYS OF STUDY TREATMENT
•6. PATIENT HAS A CONCURRENT INFECTION THAT MAY INTERFERE WITH THE EVALUATION OF RESPONSE TO THE STUDY ANTIBACTERIALS
•7. PATIENT HAS A NEED FOR EFFECTIVE CONCOMITANT SYSTEMIC ANTIBACTERIALS IN ADDITION TO THOSE ALLOWED PER PROTOCOL
•8. PATIENT IS RECEIVING HEMODIALYSIS OR PERITONEAL DIALYSIS
•9. PATIENT HAS AN ESTIMATED CRC1 <6 ML/MIN BY COCKCROFT-GAULT FORMULA (COCKCROFT AND GAULT 1976). REFER TO APPENDIX E FOR THE FORMULA FOR CALCULATING CRCL.

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