Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI) - Full Text View

Purpose

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

Condition	Intervention	Phase
Cystitis	Drug: Norfloxacin Drug: Cephalosporins	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Non-Inferiority Open-label Multicenter Randomized Clinical Trial to Compare CEPHALOSPORIN to NORFLOXACIN in the Treatment of Acute Cystitis

Resource links provided by NLM:

Drug Information available for: Norfloxacin

U.S. FDA Resources

Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:

Bacteriological Eradication [ Time Frame: 5-9 days ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Clinical Cure [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	390
Study Start Date:	October 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cephalosporin oral suspension 130 research subjects on cephalosporin oral suspension (test) 400 mg once daily	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)
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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:	NCT01527019 History of Changes
Other Study ID Numbers:	EF125
Study First Received:	January 31, 2012
Last Updated:	February 2, 2012
Health Authority:	Brazil: Ethics Committee Brazil: National Health Surveillance Agency

Keywords provided by Eurofarma Laboratorios S.A.:

Acute Cystitis

Additional relevant MeSH terms:

Cystitis
Acute Disease
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Norfloxacin
Cephalosporins

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013