CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infect… (NCT03477422) | Clinical Trial Compass
CompletedPhase 3
CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria
India230 participantsStarted 2014-01-11
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Proportion of patients with symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) at the TOC visit in the Microbiological Modified Intent-To-Treat (mMITT) analysis set
Timeframe: TOC visit (16 to 25 days after randomization)
2
Proportion of patients with both a per-patient microbiological eradication and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) at the TOC visit in the mMITT analysis set
Timeframe: TOC visit (16 to 25 days after randomization)
3
Proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set
Timeframe: TOC visit (16 to 25 days after randomization)
. 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