Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

Conditions:Other Indications, Infectious Disease, Nephrology, Urology, Urinary Tract Infections
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology, Other
Age Range:18 - Any
Start Date:September 24, 2018
End Date:December 30, 2019

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Cefepime-AAI101 Compared to Piperacillin/Tazobactam in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis.

Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg
combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients
with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU,
the US, Central, South America and South Africa.

Inclusion Criteria

1. Male or female patients >18 years of age at the time of signing of informed consent;

2. Expectation that the patient's cUTI or AP will require hospitalisation and initial
treatment with at least 7 days of intravenous (i.v.) antibiotics;

3. Female patients who are no longer of childbearing potential

4. Female patients of childbearing potential must have a negative urine and/or serum
pregnancy test (serum β-human chorionic gonadotropin) within 1 day prior to study

5. Male patients, female patients receiving hormone replacement therapy (HRT), and female
patients of childbearing potential must agree to use highly effective contraception

6. Pyuria, defined as: a. White blood cell count >10 cells/mm3 in unspun urine or ≥10
cells/high power field in spun urine sediment; or b. Urinalysis/dipstick analysis
positive for leukocyte esterase;

7. Clinical signs and/or symptoms of cUTI or AP

8. Have a baseline urine culture specimen obtained within 48 hours prior to randomization

9. Expectation, in the judgment of the Investigator, that any implanted urinary
instrumentation (e.g., nephrostomy tubes, ureteric stents, etc.) will be surgically
removed or replaced before or within 24 hours after randomisation, unless removal or
replacement is considered unsafe or contraindicated.

Exclusion Criteria

1. Known urine culture with Gram-positive primary pathogen at ≥105 colony-forming units
(CFU)/mL (not contaminant) or suspected Gram-positive pathogen by Gram staining (Note:
Gram staining is optional);

2. History of significant hypersensitivity or allergic reaction to cefepime,
piperacillin/tazobactam, any of the excipients used in the respective formulations,
any beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or
monobactams), or any beta-lactamase inhibitors (e.g., tazobactam, sulbactam, or
clavulanic acid);

3. In the opinion of the Investigator, the patient is considered unlikely to survive the
approximately 6-week study period;

4. Weight >180 kg;

5. Concurrent infection that would interfere with evaluation of response to the study

6. Need for or receipt of concomitant systemic antimicrobial agents after signing of
informed consent, in addition to those designated in the study-treatment groups, with
the exception of a single oral dose of any antifungal treatment for vaginal

7. Receipt of potentially effective systemic antibacterial therapy for a continuous
duration of > 24 hours during the previous 72 hours before the study-qualifying
baseline urine is obtained;

8. Complicated urinary tract infection (UTI) known at study entry to be caused by
pathogens resistant to the study antibiotics;

9. Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the
patient's participation in the study;

10. Intractable UTI at baseline that the Investigator anticipates would require >14 days
of study drug therapy;

11. Complete, permanent obstruction of the urinary tract that is not anticipated to be
medically or surgically relieved during i.v. study therapy and before End of Treatment

12. Gross hematuria requiring intervention other than administration of study drug or
removal or exchange of a urinary catheter;

13. Presence of any known or suspected disease or condition that, in the opinion of the
Investigator, may confound the assessment of efficacy.

14. Suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis, or chronic
bacterial prostatitis as determined by history and/or physical examination;

15. Impairment of renal function with estimated glomerular filtration rate <30 mL/min/1.73
m2 calculated by the 4-variable Modification of Diet in Renal Disease study equation,

16. Urinary tract surgery within 7 days prior to randomisation or urinary tract surgery
planned during the study period (except surgery required to relieve an obstruction or
place a stent or nephrostomy prior to EOT);

17. Any condition or circumstance that, in the opinion of the Investigator, would
compromise the safety of the patient or the quality of study data;

18. Any rapidly progressing disease or immediately life-threatening illness, including
acute hepatic failure and respiratory failure;

19. Presence of sepsis, producing life-threatening organ dysfunction

20. A QT interval corrected using Fridericia's formula >450 msec;

21. Immunocompromising condition, including known history of acquired immune deficiency
syndrome or known recent CD4 count <200/mm3, hematological malignancy, or bone marrow
transplantation; or immunosuppressive therapy including cancer chemotherapy,
medications for prevention of organ transplantation rejection, or the administration
of corticosteroids ≥20 mg of prednisone or equivalent per day administered
continuously for >14 days prior to randomisation;

22. One or more of the following laboratory abnormalities in baseline specimens obtained
at Screening: aspartate aminotransferase, alanine aminotransferase, alkaline
phosphatase, or total bilirubin level >3 × upper limit of normal, or current
clinically significant liver disease, including any form of known liver cirrhosis;

23. One or more of the following laboratory abnormalities at Screening: platelet count
<50,000/μL, absolute neutrophil count <1,000/mm3, or hemoglobin <8 g/dL;
We found this trial at
Albuquerque, New Mexico 87131
Principal Investigator: Max Gallegos, MD
Phone: 505-272-5505
Albuquerque, NM
Click here to add this to my saved trials
Anaheim, California 92804
Principal Investigator: Richard Keech, MD
Phone: 657-337-5088
Anaheim, CA
Click here to add this to my saved trials
Buena Park, California 90620
Principal Investigator: Soledad Lee, MD
Phone: 714-827-1899
Buena Park, CA
Click here to add this to my saved trials
Buenos Aires,
Principal Investigator: Javier Alejandro Cima, MD
Phone: +52 9 11 5135-9073
Buenos Aires,
Click here to add this to my saved trials
Butte, Montana 59701
Principal Investigator: John Pullman, MD
Phone: 406-723-1375
Butte, MT
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Robert Poirier, MD
Phone: 314-362-7961
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
Click here to add this to my saved trials
Tampa, Florida 33607
Principal Investigator: Osvaldo Padron, MD
Phone: 813-875-8567
Tampa, FL
Click here to add this to my saved trials