A PHASE III, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GOUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY, AND TOLERABILITY OF CEFTAZIDIME AVIBACTAM (CAZ104) PLUS METRONIDAZOLE VERSUS MEROPENEM IN THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (cIAIs)IN HOSPITALIZED ADULTS.
- Registration Number
- PER-007-12
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 36
FOR INCLUSION IN THE STUDY PATIENTS SHOULD FULFILL THE FOLLOWING CRITERIA:
1. PATIENTS MUST PROVIDE A SIGNED WRITTEN INFORMED CONSENT PRIOR TO ANY STUDY-SPECIFIC PROCEDURES. HOWEVER, IF A PATIENT IS UNABLE, THE PATIENT´S LEGALLY ACCEPTABLE REPRESENTATIVE MAY PROVIDE WRITTEN CONSENT, AS APPROVED BY THE INSTITUCIONAL-SPECIFIC GUIDELINES. THOSE PATIENTS WHO ARE UNCONSCIOUS OR CONSIDERED BY THE INVESTIGATOR TO BE CLINICALLY UNABLE TO CONSENT AT SCREENING AND WHO ARE ENTERED INTO THE STUDY BY THE CONSENT OF LEGALLY ACCEPTABLE REPRESENTATIVE, SHOULD PROVIDE THEIR OWN WRITTEN INFORMED CONSENT FOR CONTINUING TO PARTICIPATE IN THE STUDY AS SOON S POSSIBLE ON RECOVERY, AS APPLICABLE IN ACCORDANCE WITH LOCAL REGULATIONS.
2. PATIENT MUST BE 18 TO 90 YEARS OF AGE INCLUSIVE.
3. WOMEN ARE AUTHORIZED TO PARTICIPATE IF THEY MEET THE FOLLOWING CRITERIA:
(a) SURGICAL STERILIZATION OR
(b) COMPLETED MENOPAUSE, AS DEFINED BY CRITERIA IN FOOTNOTE (1) (IF CRITERIA NOT MET, SHOULD BE REGARDED AS HAVING CHILDBEARING POTENTIAL).
OR
(c) FEMALE PATIENT CAPABLE OF HAVING CHILDREN AND AGREES NOT TO ATTEMPT PREGNANCY WHILE RECEIVING IV STUDY THERAPY AND FOR A PAERIOD OF 1 WEEK AFTER. ACCEPTABLE METHODS OF CONTRACEPTION FOR THIS STUDY ARE:
. PRIOR TO AND DURING THE STUDY, USE OF AN INTRAUTERINE DEVICE, REGULAR DEPO-PROGESTERONE INJECTIONS, OR SEXUAL INTERCOURSE WHIT ONLY VASECTOMIZED PARTNERS.
. COMPLETE SEXUAL ABSTINENCE FOR THE RECOMMENDED PERIOD.
4 EITHER:
INTRAOPRATIVE/POSTO
PATIENTS SHOULD NOT ENTER THE STUDY IF ANY OF THE FOLLOWING EXCLUSION CRITERIA ARE FULFILLED:
1. PATIENT DIAGNOSED WITH TRAUMATIC BOWEL PERFORATION UNDERGOING SURGERY WITHIN 12 HOURS; PERFORATION OF GASTRODUODENAL ULCERS UNDERGOING SURGERY WITHIN 24 HOURS. OTHER INTRA-ABDOMINAL PROCESSES IN WHICH THE PRIMARY ETIOLOGY IS NOT LIKELY TO BE INFECTIOUS.
2. PATIENT HAS ABDOMINAL WALL ABSCESS OR BOWEL OBSTRUCTION WITHOUT PERFORATION OR ISCHEMIC BOWEL WITHOUT PERFOARTION.
3. PATIENT HAS SIMPLE CHOLECYSTITIS, OR GANGRENOUS CHOLECYSTITIS WITHOUT RUPTURE, OR SIMPLE APPENDICITIS, OR ACUTE SUPPURATIVE CHOLANGITIS, OR INFECTED NECROTIZING PANCREATITIS OR PANCREATIC ABSCESS.
4. PATIENT´S SURGERY WILL INCLUDE STAGED ABDOMINAL REPAIR, OR OPEN ABDOMEN TECHNIQUE, OR MARSUPIALIZATION.
5. PATIENT´S IS KNOWN AT STUDY ENTRY TO HAVE A cIAI CAUSED BY PATHOGENS RESISTANT TO THE STUDY ANTIMICROBIAL AGENTS.
6. PATIENT NEEDS EFFECTIVE CONCOMITANT SYSTEMIC ANTIBACTERIALS (ORAL, IV, OR INTRAMUSCULAR) OR ANTIFUNGALS IN ADDITION TO HOSE DESIGNATED IN THE 2 STDY GROUPS, EXCEPT VANCOMYCIN, LINEZOLID, OR DAPTOMYCIN IF STARTED FOR KNOWN OR SUSPECTED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREAUS (MRSA) OR ENTEROCOCCUS SPECIES AS PER PROTOCOL SECTION 5.6.
7. PATIENT HAS EVIDENCE OF SEPSIS WITH SHOCK NOT RESPONDING TO IV FLUID CHALLENGE OR ANTICIPATED TO REQUIRE THE AMINISTRATION OF VASOPRESSORS FOR > 12 HOURS.
8. PATIENT HAS PERINEPHRIC INFECTIONS.
9. PATIENT HAS INDEWELLING PERITONEAL DIALYSIS CAT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method