CystitisPhase 3CECINCT01527019
Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI)
A Phase 3 study testing Norfloxacin and Cephalosporins in people with Cystitis, run by Eurofarma Laboratorios S.A..
Trial summary
This study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystitis
- What is being tested?
- Norfloxacin and Cephalosporins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
- Conditions
- Cystitis
- Being tested
- Norfloxacin, Cephalosporins
- Keywords
- Acute Cystitis
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorfloxacinDrug
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)
CephalosporinsDrug
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)
CephalosporinsDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Cephalosporin oral suspension | Experimental | 130 research subjects on cephalosporin oral suspension (test) 400 mg once daily Receives: Drug: Cephalosporins |
| Cephalosporin capsules | Experimental | 130 research subjects on cephalosporin capsules (test) 400 mg once daily Receives: Drug: Cephalosporins |
| Norfloxacin | Active comparator | 130 research subjects on norfloxacin (test) 400 mg twice daily Receives: Drug: Norfloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-9 days
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2012
Why it stopped: the company suspended the persecution of this combination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527019
- Sponsor's protocol ID
- EF125
- Acronym
- CECI
- Status last verified
- Feb 2012
- First submitted
- 31 Jan 2012
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Non-Inferiority Open-label Multicenter Randomized Clinical Trial to Compare CEPHALOSPORIN to NORFLOXACIN in the Treatment of Acute Cystitis
- ClinicalTrials.gov ID
- NCT01527019
- Acronym / sponsor ID
- CECI / EF125
- Conditions
- Cystitis
- Keywords
- Acute Cystitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the company suspended the persecution of this combination
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cephalosporin oral suspension | Experimental | Drug: Cephalosporins130 research subjects on cephalosporin oral suspension (test) 400 mg once daily |
| Cephalosporin capsules | Experimental | Drug: Cephalosporins130 research subjects on cephalosporin capsules (test) 400 mg once daily |
| Norfloxacin | Active comparator | Drug: Norfloxacin130 research subjects on norfloxacin (test) 400 mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorfloxacinNorfloxacin 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 | Norfloxacin |
| CephalosporinsCephalosporins 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 | Cephalosporin capsules |
| CephalosporinsCephalosporins 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) | Drug | Cephalosporin oral suspension |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Norfloxacin and Cephalosporins in people with Cystitis, run by Eurofarma Laboratorios S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteriological Eradication (time frame: 5-9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.