PROSPECTIVE, RANDOMIZED STUDY TO COMPARE CIPROFLOXACIN (IN ORAL SUSPENSION, IV SEQUENTIAL TREATMENT, ORAL SUSPENSION OR EXCLUSIVELY IV) VERSUS ESTABLISHED COMPARATIVE REGIMES (EITHER CEFIXIME ORAL SUSPENSION, SEQUENTIAL TREATMENT WITH CEFTAZIDIME IV -> CEFIXIMA ORAL SUSPENSION OR CEFTAZIDIME EXCLUSIVELY IV) FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH COMPLICATED INFECTIONS OF THE URINARY TRACT OR PIELONEFRITIS.
- Conditions
- -N390 Urinary tract infection, site not specifiedUrinary tract infection, site not specifiedN390
- Registration Number
- PER-019-01
- Lead Sponsor
- BAYER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• age> 1 year but <17 years
• written informed consent signed by parent / legal guardian and patient (if applicable)
• a positive urine culture should be obtained by means of the medium jet method, intermittent catheterization, permanent catheterization or suprapubic puncture. Positive is defined as: urine obtained by the medium jet method:> 10 6 colony forming units per milliliter (CFU / ml); urine obtained by permanent urethral catheter; > 10 6 CFU / ml; urine obtained by aseptic intermittent urethral catheterization:> 10 6 (CFU / ml); and urine obtained by suprapubic puncture:> 10 6 (CFU / ml).
• present a current episode of complicated UTI
• Patients with complicated UTI must also meet one of the following criteria:
o permanent catheter or use of intermittent catheterization
o obstructive uropathy due to obstruction of the bladder outlet
o vesicoureteral reflux or other urological abnormalities
o functional or neurogenic micturition disorders with significant impact on bladder emptying or pressure profile in the bladder.
o recurrent UTI, defined as two or more acute UTIs in a 6-month period
o evidence that the current UTI may be caused by a resistant uropathogen, including evidence that the current episode is a new infection, or a large child or adolescent receiving chronic or intermittent antimicrobial suppression with unresolved vesicoureteral reflux.
• Patients with pyelonephritis should have fever f> 38 ° C {100.4 ° F ^ oral or> 38.6 ° C (101.4 ° F> rectal) AND at least one of the following symptoms:
o nausea and / or vomiting
o sensitivity in the costovertebral angle
• Have a known hypersensitivity to ANY of the study drug regimens or related compounds, including fluoroquinolones or cephalosporins, or severe hypersensitivity to penicillin.
• They have participated in a clinical study in the month prior to this study.
• They have been previously enrolled in this clinical study.
• They have significant liver failure (ALT / AST and / or basal bilirubin> 3 times the upper limit of normal).
• They have significant confirmed renal failure (calculated creatinine clearance <30 ml / min / 1.73m2).
• Pregnant or lactating patients, or who are sexually active and use an unreliable method of contraception,
• Patients who depend on a pediatric formula for nutrition in such a way that it is impossible to receive the dose of study medication two hours before or six hours after a meal.
• Patients who were previously treated with an effective antibacterial agent at a therapeutic dose within 48 hours prior to screening, that is, an antimicrobial that demonstrated a reduction that can be determined clinically from the signs and symptoms of this cTU.
• Require any concomitant systemic antibacterial agent.
• They present evidence of calculations.
• Have a confirmed risk of seizures, a history of seizure disorders or trauma to head injuries, who are currently receiving anticonvulsants or who have had a stroke in the past two months.
• They present AIDS (guideline when a cell count is available: CD4 count <200 / mm3).
• They have received treatment with quinolones in the 14 days prior to entering the study.
• They have a confirmed underlying rheumatologic disease, joint problems secondary to trauma or pre-existing conditions that are known to be associated with arthropathy. Patients who present conditions that prevent performing a reliable series of musculoskeletal exams should be excluded from participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method