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

Information source: Eurofarma Laboratorios S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystitis

Intervention: Norfloxacin (Drug); Cephalosporins (Drug); Cephalosporins (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Eurofarma Laboratorios S.A.

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bacteriological Eradication

Secondary outcome: Clinical Cure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: October 2012
Last updated: July 24, 2015

Page last updated: August 23, 2015

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