| Eligibility |
Inclusion Criteria:
1. Male or female, age 18 years or older (no racial/ethnic restrictions).
2. Urine specimen with evidence of pyuria:
- Dipstick analysis positive (at least trace) for leukocyte esterase OR
- Dipstick analysis positive (at least trace) for nitrates OR
- At least 10 white blood cells (WBCs) per cubic millimeter OR
- At least 10 WBCs per high power field.
3. Urine culture positive for E. coli, Pseudomonas, Acinetobacter, Staphylococcus, or
Klebsiella that is resistant to at least one first-line antibiotic.
4. Must agree to use an effective method of birth control in sexually active men and
women while taking the study drug and for one week thereafter. Barrier contraceptives
(condoms or diaphragm) with spermicide, intrauterine devices (IUD's), hormonal
contraceptives, oral contraceptive pills, surgical sterilization, and complete
abstinence are examples of effective methods of contraception.
5. Agrees to refrain from ethanol consumption during the study.
6. Must sign an informed consent document after complete explanation of the study
documenting that they understand the purpose of the study, procedures to be
undertaken, possible benefits, potential risks, and are willing to participate.
-
Exclusion Criteria:
1. In the judgment of the investigator, the subject requires hospitalization.
2. Uncomplicated lower UTI.
3. Receipt of effective antibacterial drug therapy for cUTI for a continuous duration of
more than 48 hours during the 72 hours prior to Screening.
4. Any recent (<4 weeks) history of trauma to the pelvis or urinary tract.
5. Concomitant infection that requires non-study systemic antibacterial therapy effective
against cUTI in addition to study drug.
6. Intractable UTI infection at baseline that the investigator anticipates would require
>14 days of study drug therapy.
7. Suspected or confirmed prostatitis, epididymitis.
8. Renal transplantation, urinary diversion of any type, or known vesico-ureteral reflux.
9. Have complete, permanent obstruction of the urinary tract.
10. Confirmed fungal UTI (with =103 fungal CFU/mL).
11. Suspected or confirmed perinephric or intrarenal abscess.
12. Have an indwelling urinary catheter that is considered unsafe or contraindicated to
remove. Note: Indwelling urinary catheters that have been in place for >24 hours prior
to Screening must be removed and replaced prior to sample collection.
13. Percutaneous nephrostomy tube
14. Indwelling ureteral stent
15. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery
planned during the study period.
16. Significantly abnormal laboratory values (usually defined as 2x normal such as for
liver function tests) or any other medical abnormality that, in the opinion of the
investigator, would compromise the safety of the subject or the quality of study data.
17. Lifetime history of any of the following: surgical procedures involving the brain or
meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder
(e.g., Alzheimer's Disease, Parkinson's Disease), epilepsy, mental retardation, or any
other disease/procedure/accident/intervention that, according to the clinician, is
deemed associated with significant injury to, or malfunction of, the CNS.
18. Other medical disease such as clinically significant congestive heart failure, septic
shock, coronary or peripheral vascular disease, chronic obstructive lung disease, or
malignancy.
19. Current or recent (<4 weeks) use of recreational drugs.
20. History of alcohol abuse within last six months
21. Pregnant or lactating.
22. Evidence of immunocompromise including human immunodeficiency virus (HIV) infection,
systemic or hematological malignancy requiring chemotherapeutic or
radiation/immunologic interventions, immunosuppressive therapy, including maintenance
corticosteroid therapy (>40 mg/day equivalent prednisolone for 5 days or more in the
30 days prior to randomization).
23. Have a documented history of any moderate or severe hypersensitivity or allergic
reaction to D-cycloserine, lurasidone, or both.
24. Lactose allergy
25. Ongoing participation in another clinical research study involving an investigational
product or having received another investigational product within the last 30 days.
|
