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

Primary Purpose

Cystitis

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Norfloxacin

Cephalosporins

About this trial

This is an interventional treatment trial for Cystitis focused on measuring Acute Cystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Cephalosporin oral suspension

Cephalosporin capsules

Norfloxacin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01527019

First Posted

January 31, 2012

Last Updated

July 24, 2015

Sponsor

Eurofarma Laboratorios S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01527019

Brief Title

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

Acronym

CECI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Withdrawn

Why Stopped

the company suspended the persecution of this combination

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystitis

Keywords

Acute Cystitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cephalosporin oral suspension

Arm Type

Experimental

Arm Description

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

Arm Title

Cephalosporin capsules

Arm Type

Experimental

Arm Description

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

Arm Title

Norfloxacin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Norfloxacin

Intervention Description

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

Intervention Name(s)

Cephalosporins

Intervention Description

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

Intervention Name(s)

Cephalosporins

Intervention Description

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)

Primary Outcome Measure Information:

Title

Bacteriological Eradication

Description

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.

Time Frame

5-9 days

Secondary Outcome Measure Information:

Title

Clinical Cure

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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