Clinical trial NCT01527019: Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI)
Official title: A Phase III Non-Inferiority Open-label Multicenter Randomized Clinical Trial to Compare CEPHALOSPORIN to NORFLOXACIN in the Treatment of Acute Cystitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cystitis
Keywords: Acute Cystitis
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis treatment.


Eligibility criteria: 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

Primary outcomes:
measure: Bacteriological Eradication
timeFrame: 5-9 days
Secondary outcomes:
measure: Clinical Cure
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References: