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

Study Overview
=================
Brief Summary
-----------------
This study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis 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

Conditions
-----------------
Cystitis

Intervention / Treatment
-----------------
* Drug: Norfloxacin
* Drug: Cephalosporins
* Drug: Cephalosporins


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cephalosporin oral suspension<br>130 research subjects on cephalosporin oral suspension (test) 400 mg once daily | Drug: Cephalosporins<br>* 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)<br>|
| Experimental: Cephalosporin capsules<br>130 research subjects on cephalosporin capsules (test) 400 mg once daily | Drug: Cephalosporins<br>* 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)<br>|
| Active Comparator: Norfloxacin<br>130 research subjects on norfloxacin (test) 400 mg twice daily | Drug: Norfloxacin<br>* 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)<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Cystitis