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

NCT01527019 | Withdrawn Phase 3 DMC

• 1 other identifier: EF125
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Acute Cystitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Cure

  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

Study Arms (3)

Cephalosporin oral suspension

EXPERIMENTAL

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

Drug: Cephalosporins

Cephalosporin capsules

EXPERIMENTAL

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

Drug: Cephalosporins

Norfloxacin

ACTIVE COMPARATOR

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

Drug: Norfloxacin

Interventions

Norfloxacin 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)

Norfloxacin

Cephalosporins 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)

Cephalosporin capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

MeSH Terms

Conditions

Cystitis

Interventions

Norfloxacin; Cephalosporins

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 6, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2012
• Last Updated: July 27, 2015

Record last verified: 2012-02