None listed
Conditions
Interventions
THE DURATION OF TREATMENT IS 5 TO 21 DAYS, WHERE A FULL DAY IS DEFINED AS A 24-HOUR PERIOD. THE PRECISE DURATION OF THERAPY WILL BE DETERMINED BY THE INVESTIGATOR BASED ON THE PATIENT´S RESPONSE. EACH
18 AND ≤
90 YEARS OF AGE) DIAGNOSED WITH CLAL OR CUTI CAUSED BY CEFTAZIDIME-RESISTANT GRAM-NEGATIVE PATHOGENS WILL BE ENROLLED IN THE STUDY.
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 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 OR (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.
Exclusion criteria
Exclusion criteria: 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.
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea North, Mexico, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed