Overview

CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria

Status:
Completed
Trial end date:
2017-05-08
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis caused by β-lactamase producing gram-negative bacteria
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Venus Remedies Limited
Treatments:
Anti-Infective Agents
Ceftriaxone
Edetic Acid
Meropenem
Pentetic Acid
Sulbactam
Thienamycins
Criteria
Inclusion Criteria:

1. Patients willing to provide informed consent and who are willing to or likely to
comply with all study requirements

2. Patients of either gender must have age ≥ 18 years

3. Patients with suspected cUTI based on clinical signs and symptoms

4. Urine culture results confirm bacterial urinary tract infection caused by β-lactamase
producing gram- negative bacteria requiring intravenous therapy

5. Patients with indwelling catheters should have the catheter removed or replaced (if
removal is not clinically acceptable) before or as soon as possible, but not longer
than 12 hours, after randomization

6. Obstructive uropathy, where the obstruction is likely to be relieved by stent or
nephrostomy tube no later than 24 hours after randomization

7. Patients having received antibiotics for complicated urinary tract infection only if
the duration of therapy was ≤ 24 hours within 72 hr of enrollment

8. Patients having received prior antibiotics and not showing any clinically significant
improvement irrespective of duration of therapy

9. Females of childbearing potential require a negative urine pregnancy test and must
agree to abstinence or to use an effective method of contraception

Exclusion Criteria:

1. Patients with clinically significant cardiovascular, renal, hepatic, gastrointestinal
conditions, neurological, psychiatric, respiratory, other severely immunocompromised,
haematological, or malignant disease and other condition which may interfere with the
assessment. History of uncontrolled diabetes mellitus, HIV and hepatitis B were
excluded.

2. Patients with history of resistance to any of the investigational drugs were excluded
from the study

3. Patients with history of hypersensitivity or allergic response, any contra-indications
to penicillin, cephalosporin groups of drugs

4. Patients with creatinine clearance below 30 mL/min

5. Patients having abnormal laboratory parameters which in the opinion of PI are
clinically significant enough to pose any undue safety concern for the patient or can
interfere with patient's assessment

6. Perinephritic abscess or renal corticomedullary abscess, polycystic kidney disease,
only one functional kidney, chronic vesicoureteral reflux

7. Uncomplicated UTI

8. Previous or planned renal transplantation or cystectomy

9. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery
planned during the study period (except surgery to relieve obstruction, to place a
stent or nephrostomy)

10. Patients with a Body Mass Index ≥ 35 kg/m^2

11. Pregnant or lactating women

12. Participation in any clinical study within the previous 6 months