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

A Phase III Non-Inferiority Open-label Multicenter Randomized Clinical Trial to Compare CEPHALOSPORIN to NORFLOXACIN in the Treatment of Acute Cystitis

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

Study Overview

• Status: Withdrawn
• Conditions: Cystitis
• Intervention / Treatment: Drug: Cephalosporins; Drug: Cephalosporins; Drug: Norfloxacin

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cephalosporin oral suspension; 130 research subjects on cephalosporin oral suspension (test) 400 mg once daily	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); 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)
Experimental: Cephalosporin capsules; 130 research subjects on cephalosporin capsules (test) 400 mg once daily	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); 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)
Active Comparator: Norfloxacin; 130 research subjects on norfloxacin (test) 400 mg twice daily	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 6, 2012

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: July 24, 2015
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Acute Cystitis
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cephalosporins; Norfloxacin
• Other Study ID Numbers: EF125