Status:
COMPLETED
CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria
Lead Sponsor:
Venus Remedies Limited
Conditions:
Urinary Tract Infection Complicated
Acute Pyelonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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, incl...
Detailed Description
cUTIs are mostly caused by gram-negative bacteria, including Enterobacteriaceae (particularly Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis) and Pseudomonas aeruginosa, and often posse...
Eligibility Criteria
Inclusion
- Patients willing to provide informed consent and who are willing to or likely to comply with all study requirements
- Patients of either gender must have age ≥ 18 years
- Patients with suspected cUTI based on clinical signs and symptoms
- Urine culture results confirm bacterial urinary tract infection caused by β-lactamase producing gram- negative bacteria requiring intravenous therapy
- 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
- Obstructive uropathy, where the obstruction is likely to be relieved by stent or nephrostomy tube no later than 24 hours after randomization
- Patients having received antibiotics for complicated urinary tract infection only if the duration of therapy was ≤ 24 hours within 72 hr of enrollment
- Patients having received prior antibiotics and not showing any clinically significant improvement irrespective of duration of therapy
- Females of childbearing potential require a negative urine pregnancy test and must agree to abstinence or to use an effective method of contraception
Exclusion
- 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.
- Patients with history of resistance to any of the investigational drugs were excluded from the study
- Patients with history of hypersensitivity or allergic response, any contra-indications to penicillin, cephalosporin groups of drugs
- Patients with creatinine clearance below 30 mL/min
- 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
- Perinephritic abscess or renal corticomedullary abscess, polycystic kidney disease, only one functional kidney, chronic vesicoureteral reflux
- Uncomplicated UTI
- Previous or planned renal transplantation or cystectomy
- 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)
- Patients with a Body Mass Index ≥ 35 kg/m\^2
- Pregnant or lactating women
- Participation in any clinical study within the previous 6 months
Key Trial Info
Start Date :
January 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2017
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT03477422
Start Date
January 11 2014
End Date
May 8 2017
Last Update
August 29 2019
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Sher-i-Kashmir Institute of Medical Sciences (SKIMS)
Srinagar, Jammu and Kashmir, India, 190011
2
Sapthagiri Institute of Medical Sciences and Research Center
Bangalore, Karnataka, India, 560 090
3
KLES, Dr Prabhakar Kore Hospital and Medical Centre , , India
Belagavi, Karnataka, India, 590010
4
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India, 411004