None listed
Conditions
Interventions
Stratum I Arm I Type of group
Oral ciprofloxacin at a dose of 5 to 20 mg / kg every 12 hours (1,500 mg per day maximum) to complete 7 to 21 days inclusive of total oral treatment
Group name:Stratum II Arm II Type of group
Intravenous ceftazidime at a dose of 30 mg / kg every 8 hours (6 grams per day maximum)
OR
Intravenous ceftazidime at a dose of 30 mg / kg every 8 hours (6 grams per day maximum) followed by oral cefixime at a dose of 4 mg / kg every 12 hours (400 mg maximum each day) for patients weighing 50kg and over 12 years of age will be treated with the recommended adult dose of 200 mg every 12 hours. The oral treatment will continue in order to complete 7 to 21 days inclusive of total treatment.
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • age> 1 year but 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Examination of the march and joints. A two-tailed 95% Confidence Interval will be constructed for the weighted difference between treatment groups in the Arthropathy Incidence indices using the Mantel-Haenszel weights that reflect the stratum of the disease. Measure:Index of incidence of arthropathy in the first follow-up visit Timepoints:Day 28 to day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The events will be tabulated by type and frequency, for all events and for those events that the Investigator considers have a possible or probable relationship with the drug treatment. Measure:Incidence indices of all types of adverse events Timepoints:Day 28 to day 42 ; Outcome name:Clinical evaluation A two-tailed 95% confidence interval will be constructed for the weighted difference between the treatment groups in the clinical success rates using the Mantel-Haenszel weights based on the stratum of the disease. Measure:Clinical success rate (resolution) Timepoints:Day 5 to day 9 | — |
Outcome results
None listed