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

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ClinicalTrials.gov Identifier: NCT01527019
Recruitment Status : Withdrawn (the company suspended the persecution of this combination)
First Posted : February 6, 2012
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

January 31, 2012
February 6, 2012
July 27, 2015
October 2012
October 2012   (Final data collection date for primary outcome measure)
Bacteriological Eradication [ Time Frame: 5-9 days ]
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.
Same as current
Complete list of historical versions of study NCT01527019 on ClinicalTrials.gov Archive Site
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 ]
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.
Same as current
Not Provided
Not Provided
 
Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cystitis
  • 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)
  • 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 oral suspension
    130 research subjects on cephalosporin oral suspension (test) 400 mg once daily
    Intervention: Drug: Cephalosporins
  • Experimental: Cephalosporin capsules
    130 research subjects on cephalosporin capsules (test) 400 mg once daily
    Intervention: Drug: Cephalosporins
  • Active Comparator: Norfloxacin
    130 research subjects on norfloxacin (test) 400 mg twice daily
    Intervention: Drug: Norfloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
390
Not Provided
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01527019
EF125
Yes
Not Provided
Not Provided
Eurofarma Laboratorios S.A.
Eurofarma Laboratorios S.A.
Not Provided
Not Provided
Eurofarma Laboratorios S.A.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP