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

Eurofarma

Status and phase: Withdrawn; Phase 3

Conditions: Cystitis

Treatments: Drug: Norfloxacin; Drug: Cephalosporins

Study type: Interventional

Funder types: Industry

Identifiers

NCT01527019

EF125

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Cephalosporin oral suspension

Experimental group

Description:

130 research subjects on cephalosporin oral suspension (test) 400 mg once daily

Treatment:

Drug: Cephalosporins

Drug: Cephalosporins

Cephalosporin capsules

Experimental group

Description:

130 research subjects on cephalosporin capsules (test) 400 mg once daily

Treatment:

Drug: Cephalosporins

Drug: Cephalosporins

Norfloxacin

Active Comparator group

Description:

130 research subjects on norfloxacin (test) 400 mg twice daily

Treatment:

Drug: Norfloxacin