Cystitis Clinical Trial
— CECIOfficial title:
A Phase III Non-Inferiority Open-label Multicenter Randomized Clinical Trial to Compare CEPHALOSPORIN to NORFLOXACIN in the Treatment of Acute Cystitis
NCT number | NCT01527019 |
Other study ID # | EF125 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 3 |
First received | January 31, 2012 |
Last updated | July 24, 2015 |
Start date | October 2012 |
This study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis treatment.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Sign, initialize and date the informed consent form - Age = 18 years - For urinary infection diagnosis, the following parameters must be considered in the urine I test: - Leukocyturia: = 15,000 leukocytes - Epidermal cells: < 20,000/mL - Presence of bacteriuria - Presence of nitrite (positive results) - To have a 2 points score (from 12 points) regarding the following symptoms of acute cystitis: - Dysuria - Urinary urgency - Frequent urination - Pain in the upper area of pubis Each symptom must be scored according to the classification below. Total score may range from 0 to 12 points. Severity Value Absent 0 Mild 1 Moderate 2 Severe 3 Exclusion Criteria: Research subjects that meet any of the criteria below will not be eligible for the study: - Asymptomatic urinary infection or infection in any organ - Documented incidence of UTI in the last year - Symptoms of pyelonephritis (cystitis symptoms plus fever, lower back pain or chills) - History of complicated urinary tract infection (congenital abnormalities, urinary tract distortion or obstruction, formation of calculus in the urinary tract) - Use of catheter in the urinary tract - Chronic renal or hepatic disease - Seizure-related diseases - Neurological deficits that interfere in the urinary flow and tract defense - Decompensated diabetes mellitus (fasting blood glucose = 150 mg/dL); - Immunodepression: - Subjects with the human immunodeficiency virus (HIV) - Chronic use of corticosteroids in a dose = 5 mg/day of prednisone for over 30 days - Any diseases related to immune dysfunction - Severe comorbidities (at the investigator's discretion) - History of allergy to penicillins, cephalosporines or quinolones - Subjects on medications such as antibiotics, amiodarone, antacids or sucralphate, tricyclic antidepressants, antipsychotics, cyclosporine, cisapride, didanosine, erythromycin, fembufeno, gliburide (a sulphonilurea), nitrofurantoin, probenecid, procainamide, quinidine, sotalol, teophylline, warfarin - Treatment due to UTI two weeks before entering study, or on antimicrobial treatment at least 3 times within the last 12 months - Use of phenazopyridine 7 days before entering the study - Hospitalization 30 days before study enrollment - Female research subjects that are pregnant, breastfeeding, or women with childbearing potential that deny to use at least two safe contraceptive methods during study - Participation in another clinical trial in the last 12 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eurofarma Laboratorios S.A. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bacteriological Eradication | The primary endpoint of this study will be the bacteriological eradication rate obtained 5-9 days following the end of the treatment with study drugs. | 5-9 days | Yes |
Secondary | Clinical Cure | To determine the bacteriological eradication rate 4-6 weeks after the end of treatment; To determine the clinical cure rate 5-9 days after the end of treatment; To determine the clinical cure rate 4-6 weeks after the end of treatment; To determine the clinical cure rate for research subjects with negative uroculture 5-9 days and 4-6 weeks after the end of treatment; To assess the research subjects adherence to the study treatment; To assess the safety of antibiotics according to the incidence of adverse events and serious adverse events. | bacteriological eradication rate 4-6 weeks; clinical cure rate 5-9 days; clinical cure rate 4-6 weeks;uroculture 5-9 days and 4-6 weeks | Yes |
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