None listed
Conditions
Interventions
APPROXIMATELY 780 SUBJECTS WILL BE ENROLLED AND RANDOMIZED 1:1 TO RECIBE CXA-201 AND METRONIDAZOLE OR COMPARADOR (MEROPENEM). RANDOMIZATION WILL BE STRATIFIED BY ANATOMIC SITE FOR INFECTION (BOWEL [S
AND
FOR THE MEROPENEM GROUP: 60-MIN INFUSION OF MEROPENEM (Q8H [± 2 HOURS] FOLLOWING THE PREVIOUS MEROPENEM INFUSION), FOLLOWED BY A 60-MIN DUMMY UNFUSION (SALINE).
Sponsors
Cubist Pharmaceuticals, Inc,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. PROVIDE WRITTEN INFORMED CONSENT PRIOR TO ANY STUDY-RELATED PROCEDURE NOT PART OF NORMAL MEDICAL CARE (A LEGALLY ACCEPTABLE REPRESENTATIVE MAY PROVIDE CONSENT IF THE SUBJECT IS UNABLE TO DO SO, PROVIDED THIS IS APPROVED BY LOCAL COUNTRY AND INSTITUTION SPECIFIC GUIDELINES). 2. BE MALES OR FEMALES ≥ 18 YEARS OF AGE. 3. IF FEMALE, SUBJECT IS NON-LACTATING, AND IS EITHER: A. NOT OF CHILDBEARING POTENTIAL, DEFINED AS POSTMENOPAUSAL FOR AT LEAST 1 YEAR OR SURGICALLY STERILE DUE TO BILATERAL TUBAL LIGATION, BILATERAL OOPHORECTOMY, OR HYSTERECTOMY; OR B. OF CHILDBEARING POTENTIAL AND IS PRACTICING A BARRIER METHOD OF BIRTH CONTROL (E.G., A DIAPHRAGM OR CONTRACEPTIVES SPONGE) ALONG WITH 1 OF THE FOLLOWING METHODS: ORAL OR PATENTERAL CONTRACEPTIVES (FOR 3 MONTHS PRIOR TO STUDY DRUG ADMINISTRATION), OR A VASECTOMIZED PARTNER. OR,THE SUBJECT IS PRACTICING ABSTINENCE FROM SEXUAL INTERCOURSE. SUBJECTS MUST BE WILLING TO PRACTICE THESE METHODS FOR THE DURATION OF THE TRIAL AND FOR AT LEAST 35 DAYS AFTER LAST DOSE OF STUDY MEDICATION. 4. MALES ARE REQUIRED TO PRACTICE RELIABLE BIRTH CONTROL METHODS (CONDOM OR OTHER BARRIER DEVICE) DURING THE CONDUCT OF THE STUDY AND FOR AT LEAST 35 DAYS AFTER LAST DOSE OF STUDY MEDICATION.
Exclusion criteria
Exclusion criteria: 1. DIAGNOSIS OF ABDOMINAL WALL ABSCESS; SMALL BOWEL OBSTRUCTION OR ISCHEMIC BOWEL DISEASE WITHOUT PERFORATION. 2. SIMPLE APPENDICITIS; ACUTE SUPPURATIVE CHOLANGITIS; INFECTED NECROTIZING PANCREATITIS; PANCREATIC ABSCESS; OR PELVIC INFECTIONS. 3. SPONTANEOUS [PRIMARY] BACTERIAL PERITONITIS ASSOCIATED WITH CIRRHOSIS AND CHRONIC ASCITES. 4. COMPLICATED INTRAABDOMINAL INFECTION MANAGED BY STAGED ABDOMINAL REPAIR (STAR), OPEN ABDOMEN TECHNIQUE INCLUDING TEMPORARY CLOSURE OF THE ABDOMEN, OR ANY SITUATION WHERE INFECTION SOURCE CONTROL IS NOT LIKELY TO BE ARCHIEVED. 5. KNOWN PRIOR TO RANDOMIZATION TO HAVE AN IAI OR POSTOPERATIVE INFECTION CAUSED BY PATHOGEN(S) RESISTANT TO MEROPENEM. 6. USE OF SYSTEMIC ANTIBIOTIC THERAPY IAI FOR MORE THAN 24 HOURS PRIOR TO THE FIRST DOSE OF STUDY DRUG, UNLESS THERE IS A DOCUMENTED TREATMENT FAILURE WITH SUCH THERAPY. 7. MORE THAN ONE DOSE OF AN ACTIVE NON-STUDY ANTIBACTERIAL REGIMEN GIVEN POSTOPERATIVELY. FOR SUBJECTS ENROLLED PREOPERATIVELY , NO POSTOPERATIVE NON-STUDY ANTIBACTERIAL THERAPY IS ALLOWED. 8. SUBJECTS WHO PREVIOUS RECEIVED IMIPENEM, MEROPENEM, DORIPENEM OR CEFEPIME FOR THE CURRENT INTRAABDOMINAL INFECTION. 9. HAVE A CONCOMITANT INFECTION AT THE TIME OF RANDOMIZATION, WHICH REQUIRES NON-STUDY SYSTEMIC ANTIBACTERIAL THERAPY IN ADDITION TO IV STUDY DRUG THERAPY. (DRUGS WITH ONLY GRAM-POSITIVE ACTIVITY {E.J., DAPTOMICYN, VANCOMICYN, LINEZOLID] ARE ALLOWED).
Countries
Australia, Belgium, Georgia, Mexico, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United States
Contacts
Public ContactTeresa Nancy Victoria Laos
PHARMACEUTICAL RESEARCH ASSOCIATES PERU SAC
Outcome results
None listed