None listed
Conditions
Interventions
APPROXIMATELY 776 SUBJECTS WILL BE ENROLLED INTO THIS STUDY AND RANDOMIZED 1:1 RATIO TO RECEIVE CXA-201 OR COMPARATOR (LEVOFLOXACIN) RESULTING IN 330 mMITT SUBJECTS PER TREATMENT ARM. THIS SAMPLE SIZE
Sponsors
Cubist Pharmaceuticals, Inc,
Eligibility
Age
18 Years to 120 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 TUBL LIGATION, BILATERAL OOPHORECTOMY, OR HYSTERECTOMY; OR B. OF CHILDBEARING POTENTIAL AND IS PRACTICING A BARRIER METHOD OF BIRTH CONTROL (e.g., A DIAPHRAGM OR CONTRACEPTIVE SPONGE) ALONG WITH 1 OF THE FOLLOWING METHODS: ORAL OR PARENTERAL CONTRACEPTIVES (FOR 3 MONTHS PRIOR TO STUDY DRUG ADMINISTRATION), OR A VASECTOMIZED PARTNER. 0R, 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 3S DAYS AFTER LAST DOSE OF STUDY MEDICATION.
Exclusion criteria
Exclusion criteria: 1. HAVE A DOCUMENTED HISTORY OF ANY MODERATE OR SEVERE HYPERSENSITIVITY OR ALLERGIC REACTION TO ANY β-LACTAM ANTIBACTERIAL (A HISTORY OF A MILD RASH FOLLOWED BY UNEVENTFUL RE-EXPOSURE IS NOT A CONTRAINDICATION TO ENROLLEMENT). 2. HAVE A CONCOMITANT INFECTION AT THE TIME OF RANDOMIZATION, WHICH REQUIRES NON-STUDY SYSTEMIC ANTIBACTERIAL THERAPY IN ADDITON TO IV STUDY DRUG THERAPY. (DRUGS WITH ONLY GRAM- POSITIVE ACTIVITY [e.g., VANCOMYCIN, LINEZOLID] ARE ALLOWED.) 3. RECEIPT OF ANY AMOUNT OF POTENTIALLY THERAPEUTIC ANTIBACTERIAL THERAPY AFTER COLLECTION OF THE PRETREATMENT BASELINE URINE CULTURE AND BEFORE ADMINISTRATION OF THE FIRST DOSE OF STUDY DRUG. 4. RECEIPT OF ANY DOSE OF A POTENTIALLY THERAPEUTIC ANTIBACTERIAL AGENT FOR THE TREATMENT OF THE CURRENT UTI WITHIN 48 HOURS BEFORE THE STUDY-QUALIFYING PRETREATMENT BASELINE URINE IS OBTAINED (EXCEPTIONS: SUBJECTS WITH AN ACTIVE cUTI WHO HAVE RECEIVED PRIOR ANTIBIOTICS MAY BE ENROLLED PROVIDED A MINIMUM OF 48 HOURS HAVE ELAPSED BETWEEN THE LAST DOSE OF THE PRIOR ANTIBIOTIC AND THE TIME OF OBTAINING THE BASELINE URINE SPECIMEN.
Countries
Bulgaria, Chile, Croatia, India, Korea North, Peru, Poland, Russian Federation, Slovenia, Spain, Ukraine, United States
Contacts
Public ContactTeresa Nancy Victoria Laos
PHARMACEUTICAL RESEARCH ASSOCIATES PERU SAC
Outcome results
None listed