None listed
Conditions
Interventions
COMPLICATED UTI INCLUDES ACUTE PYELONEPHRITIS, UTIS IN MEN WITH A DOCUMENTED HISTORY OF CHRONIC URINARY RETENTION, OR UTI ASSOCIATED WITH OBSTRUCTION, FOREIGN BODIES, RECENT URINARY INSTRUMENTATION, O
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT 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 INSTITUTIONAL 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 A LEGALLY ACCEPTABLE REPRESENTATIVE SHOULD PROVIDE THEIR OWN WRITTEN INFORMED CONSENT FOR CONTINUING TO PARTICIPATE IN THE STUDY AS SOON AS POSSIBLE ON RECOVERY, AS APPLICABLE IN ACCORDANCE WITH LOCAL REGULATIONS. 2. PATIENT MUST BE 18 TO 90 YEARS OF AGE, INCLUSIVE. 3. PATIENT HAS A CLINICALLY SUSPECTED AND/OR BACTERIOLOGICALLY DOCUMENTED CUTI OR ACUTE PYELONEPHRITIS JUDGED BY THE INVESTIGATOR TO BE SERIOUS (REQUIRES PATIENT TO BE HOSPITALIZED FOR TREATMENT WITH IV THERAPY). 4. FEMALE PATIENT IS AUTHORIZED TO PARTICIPATE IN THIS CLINICAL STUDY IF SHE MEETS THE FOLLOWING CRITERIA:
Exclusion criteria
Exclusion criteria: 1. A GRAM STAIN OR URINE CULTURE (IF URINE CULTURE RESULTS ARE AVAILABLE) DEMONSTRATES THAT A GRAM-POSITIVE ORGANISM IS PRESENT AT ≥ 10⁵ CFU/ML. 2. WHERE A URINE CULTURE RESULT IS AVAILABLE, AT LEAST 1 GRAM-NEGATIVE UROPATHOGEN IS RESISTANT TO CAZ-A VI OR DORIPENEM. 3. WHERE A URINE CULTURE RESULT IS AVAILABLE, PATIENT´S URINE CULTURE AT STUDY ENTRY ISOLATES MORE THAN 2 MICROORGANISMS REGARDLESS OF THE COLONY COUNT. 4. WHERE A URINE CULTURE RESULT IS AVAILABLE, PATIENT HAS A CONFIRMED FUNGAL UTI WITH COLONY COUNT > 10₃ /ML. 5. PATIENT HAS RECEIVED ANY PRIOR ANTIBIOTIC BEFORE THE INITIATION OF STUDY THERAPY FOR THIS INFECTION. 6. PATIENT IS RECEIVING PROPHYLACTIC ANTIBIOTICS, UNLESS THE PROPHYLACTIC ANTIBIOTICS ARE STOPPED AT STUDY ENTRY. 7. PATIENT NEEDS EFFECTIVE CONCOMITANT SYSTEMIC ANTIBACTERIALS (IE, ORAL, INTRAMUSCULAR, AND/OR IV) IN ADDITION TO THOSE DESIGNATED IN THE 2 TREATMENT GROUPS. 8. PATIENT HAS COMPLETE OBSTRUCTION OF ANY PORTION OF THE URINARY TRACT, PERINEPHRIC OR INTRARENAL ABSCESS, PROSTATITIS, OR HISTORY OF ANY ILLNESS THAT, IN THE OPINION OF THE INVESTIGATOR, MAY CONFOUND THE RESULTS OF THE STUDY OR POSE ADDITIONAL RISK IN ADMINISTERING THE STUDY THERAPY TO THE PATIENT.
Countries
Argentina, Brazil, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Korea North, Mexico, Peru, Poland, Romania, Russian Federation, Spain, Taiwan, Ukraine, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed