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

NCT ID: NCT01527019

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31

Brief Summary

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

Conditions

Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cephalosporin oral suspension

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

Group Type: EXPERIMENTAL

Cephalosporins

Intervention Type: DRUG

Cephalosporins Oral Suspension, 400 mg once daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)

Cephalosporin capsules

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

Group Type: EXPERIMENTAL

Cephalosporins

Intervention Type: DRUG

Cephalosporins Caps, 400 mg once daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)

Norfloxacin

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

Group Type: ACTIVE_COMPARATOR

Norfloxacin

Intervention Type: DRUG

Norfloxacin Pills, 400 mg twice daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)

Interventions

Norfloxacin

Norfloxacin Pills, 400 mg twice daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)

Intervention Type: DRUG

Cephalosporins

Cephalosporins Caps, 400 mg once daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)

Intervention Type: DRUG

Cephalosporins

Cephalosporins Oral Suspension, 400 mg once daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EF125

Identifier Type: -

Identifier Source: org_study_id