Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI)

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Cephalosporins; Norfloxacin

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